Activities of Nicolás GONZÁLEZ CASARES related to 2023/0132(COD)
Shadow opinions (1)
OPINION on the proposal for a directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC
Amendments (384)
Amendment 21 #
Proposal for a directive
Recital 3
Recital 3
(3) This revision is part of the implementation of the Pharmaceutical strategy for Europe and aims to promote innovation, in particular for unmet medical needs, while reducing regulatory burden and the environmental impact of medicines; ensure access to innovative and est, ensure access to innovative and established medicines for patients and improve affordabilished medicines for patientty of these medicines, with special attention to enhancing security of supply and addressing risks of shortages, taking into account the challenges of the smaller markets of the Union; promote innovation, in particular for unmet medical needs, while reducing regulatory burden and the environmental impact of medicines; and create a balanced and competitive system that keeps medicines affordable for health systems whileand patients while particularly rewarding targeted innovation that improves access to medicinal products in all Member States, where they address unmet medical needs and where preclincial studies and development has taken place in the Union, reinforcing our industrial ecosystems.
Amendment 29 #
Proposal for a directive
Recital 6
Recital 6
(6) The regulatory framework for medicinal products for human use should also take into account the needs of the undertakings in the pharmaceutical sector and trade in medicinal products within the Union, without jeopardising the quality, safety and efficacy of medicinal products.
Amendment 32 #
Proposal for a directive
Recital 11
Recital 11
(11) The Directive should work in synergy with the Regulation to enable innovation and promote competitiveness of the Union pharmaceutical industry, in particular SMEs. In this respect a balanced system of incentives is proposed that rewards innovation especially in areas of unmet medical need and, innovation that reaches patients and improves access across the Union and innovation that stems from preclinical studies developed in the Union. To make the regulatory system more efficient and innovation- friendly the Directive also aims at reducing administrative burden and simplifying procedures for undertakings.
Amendment 35 #
Proposal for a directive
Recital 11 a (new)
Recital 11 a (new)
(11 a) It is however, difficult to establish a direct link between incentives offered nowadays at Union level and Union competitiveness in the pharmaceutical sphere vis a vis third country based companies. While incentives can make the EU a more attractive market for industry, they remain agnostic to medicines´ geographical origin. Medicines originating from third country based companies are eligible to all EU incentives. Equally, EU based innovative companies can benefit from incentives elsewhere if they sell their products in these markets. Therefore a reduction in the regulatory data protection period does not harm EU companies vis a vis non EU companies coming to the EU market in terms of competitiveness.
Amendment 37 #
Proposal for a directive
Recital 11 b (new)
Recital 11 b (new)
(11 b) However, to improve research and development in the pharmaceutical sphere stemming from the Union, as well as contributing to open EU strategic autonomy, it could be beneficial to establish a direct link between preclinical studies conducted in the Union and an incentive pronlonging data protection for a medicinal product. Therefore, an incentive to extend the data protection period is proposed where a company can demonstrate this.
Amendment 41 #
Proposal for a directive
Recital 15
Recital 15
(15) In order to take account both of the emergence of new therapies and of the growing number of so-called ‘borderline’ products between the medicinal product sector and other sectors, certain definitions and derogations should be modified, so as to avoid any doubt as to the applicable legislation. With the same objective of clarifying situations when a product fully falls within the definition of a medicinal product and also meet the definition of other regulated products, the rules for medicinal products under this Directive applyAgency and the advisory and regulatory bodies established in other Union legislation, as relevant, should engage in consultations, in order to find consensus on the regulatory status of the product or the application of Union law to the borderline product in question. Where necessary, the Commission should be empowered to take the decision on the regulatory status or applicability of legal rules to the borderline product,the assessment and conclusions of which should be made publicly available. Furthermore, for transparency purposes, the respective opinions and conclusions of the Agency and the other advisory and regulatory bodies established in other Union legislation should be made publicly available. Furthermore, to ensure the clarity of applicable rules, it is also appropriate to improve the consistency of the terminology of the pharmaceutical legislation and clearly indicate the products excluded from the scope of this Directive.
Amendment 42 #
Proposal for a directive
Recital 17 a (new)
Recital 17 a (new)
(17 a) For SoHO derived medicinal products each Member State shoud ensure through public service obligations that those manufacturers provide an appropriate and continuous supply of SoHO derived medicinal products to patients in their territory. Member States should negotiate fair and transparent prices for SoHO derived medicinal products that are derived from altruistic and unpaid donations. Member States should also ensure that affordable SoHO derived medicinal products are available to patients in their territory. In this regard, manufactureres of these products should report annually to authorities on the quantities prepared and the amount supplied for public use.
Amendment 46 #
Proposal for a directive
Recital 18
Recital 18
(18) Advanced therapy medicinal products that are prepared on a non- routine basis according to specific quality standards, and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient, should be excluded from the scope of this Directive whilst at the same time ensuring that relevant Union rules related to quality and safety are not undermined (‘hospital exemption’). Experience has shown that there are great differences in the application of hospital exemption among Member States. To improve the application of hospital exemption this Directive introduces measures for collection, reporting of data as well as review of these data yearly by the competent authorities and their publication by the Agency in a repository. Furthermore, the Agency should provide a report on the implementation of hospital exemption on the basis of contributions from Member States in order to examine whether an adapted framework should be established for certain less complex ATMPs that have been developed and used under the hospital exemption. When an authorisation for the manufacturing and use of an ATMP under hospital exemption is revoked because of safety concerns, the relevant competent authorities shall inform the competent authorities of other Member States.
Amendment 47 #
Proposal for a directive
Recital 18 a (new)
Recital 18 a (new)
(18 a) Hospital exemption pathway is a crucial way of providing patients with access to innovative and affordable treatments that may not be available through other channels. Any limitations to this pathway should avoided, but only based on efficacy, quality and safety criteria, without time restrictions or restrictions on quantities. Competent authorities must guarantee that the authorisation of other products through the centralized procedure does not adversely affect the activities and responsibilities of developers functioning under the hospital exemption. The Agency, as well as competent authorities at the national level, should support academic institutions and other non-profit entities through the requirements of the hospital exemption clause and, when adequate, should provide guidance through centralised marketing authorisation procedure.
Amendment 53 #
Proposal for a directive
Recital 27
Recital 27
(27) Certain particulars and documentation that are normally to be submitted with an application for a marketing authorisation should not be required if a medicinal product is a generic medicinal product or a similar biological medicinal product (biosimilar) that is authorised or has been authorised in the Union. Both generic and biosimilar medicinal products are important to ensure access of medicinal products to a wider patient population at more affordable prices and create a competitive internal market . In a joint statement authorities of the Member States confirmed that the experience with approved biosimilar medicinal products over the past 15 years has shown that in terms of efficacy, safety and immunogenicity they are comparable to their reference medicinal product and are therefore interchangeable and can be used instead of its reference product (or vice versa) or replaced by another biosimilar of the same reference product.
Amendment 54 #
Proposal for a directive
Recital 31
Recital 31
(31) Directive 2010/63/EU of the European Parliament and of the Council43[1] lays down provisions on the protection of animals used for scientific purposes based on the principles of replacement, reduction and refinement. Any study involving the use of animals, which provides essential information on the quality, safety and efficacy of a medicinal product, should take into account those principles of replacement, reduction and refinement, where they concern the care and use of live animals for scientific purposes, and should be undertaken as a last resort and be optimised in order to provide the most satisfactory results whilst using the minimum number of animals. The marketing authorisation applicant should not carry out animal tests in case scientifically satisfactory non-animal testing methods are available. Where scientifically satisfactory non-animal testing methods are not available, applicants that use animal testing should ensure that the principle of replacement, reduction and refinement of animal testing for scientific purposes has been with regard to any animal study conducted for the purpose of supporting the application. The procedures of such testing should be designed to avoid causing pain, suffering, distress or lasting harm to animals and should follow the available EMA and ICH guidelines. In particular, the marketing authorisation applicant and the marketing authorisation holder should take into account the principles laid down in Directive 2010/63/EU, including, where possible, use new approach methodologies in place of animal testing. These can include but are not limited to: in vitro models, such as microphysiological systems including organ-on-chips, (2D and 3D-) cell culture models, organoids and human stem cells-based models; in silico tools or read-across models. _________________ 43 Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).
Amendment 55 #
Proposal for a directive
Recital 39
Recital 39
(39) In the interest of as broad as possible access to medicinal products, a Member State that has an interest in receiving access to a particular medicinal product undergoing authorisation through the decentralised and mutual recognition procedures should be able to opt-into that procedure. A Member State who did not join the initital application for the decentralised procedure within 30 days of the sumission of the application should still have a second opportunity to opt into the procedure at a later point, in this case they should immeditately inform the applicant and the competent authority of the reference Member State for the decentralised procedure.
Amendment 57 #
Proposal for a directive
Recital 44
Recital 44
(44) As regards access to medicinal products, previous amendments to the Union pharmaceutical legislation have addressed this issue by providing for accelerated assessment of marketing authorisation applications or by allowing conditional marketing authorisation for medicinal products for unmet medical need. While these measures accelerated the authorisation of innovative and promising therapies, these medicinal products do not always reach the patient and patients in the Union still have different levels of access to medicinal products. Patient access to medicinal products depends on many factors. Marketing authorisation holders are not obliged to market a medicinal product in all Member States; they may decide not to market their medicinal products in, or withdraw them from, one or more Member States, often due to profitability considerations. National pricing and reimbursement policies, the size of the population, the organisation of health systems, and national administrative procedures are other factors influencing market launch and patient access.
Amendment 58 #
Proposal for a directive
Recital 45
Recital 45
(45) Addressing unequal patient access and affordability of medicinal products has become a key priority of the Pharmaceutical Strategy for Europe, as also highlighted by Council conclusions 45 and a resolution of the European Parliament 46 . Member States called for revised mechanisms and incentives for development of medicinal products tailored to the level of unmet medical need, while ensuring health system sustainability, patient access and availability of affordable medicinal products in all Member States. _________________ 45 Council conclusions on strengthening the balance in the pharmaceutical systems in the EU and its Member States, (OJ C, C/269, 23.07.2016, p. 31). Council Conclusions on Access to medicines and medical devices for a Stronger and Resilient EU, (2021/C 269 I/02). 46 European Parliament resolution of 2 March 2017 on EU options for improving access to medicine (2016/2057(INI)) Shortages of medicines, 2020/2071(INI)Puting in place tolls to evaluate access to medicines at a Union level is key to follow-up on the results achieved through incentives.
Amendment 61 #
Proposal for a directive
Recital 48
Recital 48
(48) While pricing and reimbursement decisions are a Member State competence, the Pharmaceutical Strategy for Europe announced actions to support cooperation of Member States to improve affordability. The Commission has transformed the group of National Competent Authorities on Pricing and Reimbursement and public healthcare payers (NCAPR) from an ad- hoc forum to a continuous voluntary cooperation with the aim to exchange information and best practices on pricing, payment and procurement policies to improve the affordability and cost- effectiveness of medicines and health system’s sustainability. The Commission is committed to stepping up this cooperation and further supporting information exchange among national authorities, including on public procurement of medicines, while fully respecting the competences of Member States in this area. Such procurement efforts should be based on the principle of the ‘most economically advantageous tender’ (‘MEAT’ criteria), which aims to ensure the best value for money rather than most economically advantageous product. Such an approach could also help in defining adequate supply in relation to critical medicines and, thereby, compensate and incentivise industry, and support the application of these criteria in a coordinated way, at EU level. Predictability of supply would also be helped by medium-term contractual incentives to diversify and attract the next generation of manufacturing investments in Europe. The Commission may also invite NCAPR members to participate in deliberations of the Pharmaceutical Committee on topics that may have an impact on pricing or reimbursement policies, such as the market launch incentive.
Amendment 67 #
Proposal for a directive
Recital 49 a (new)
Recital 49 a (new)
(49 a) Practices in procurement procedures for medicines differ between Member States and long-term availability is rarely a primary consideration. The 2014 Procurement Directive encourages a more strategic approach through award criteria, including criteria beyond price. Using the lowest price as the main selection criterion may reduce incentives for the industry to build for long-term supply in the EU. At the same time, vulnerability may be increased when public procurement procedures award contracts to a single company. Where challenges with access to a critical medicine and related affordability may be an issue, Member States can work together to increase buying power. Joint procurement between Member States can act as a powerful tool to improve access, affordability and security of supply, of particular benefit in smaller EU markets. This can improve the negotiating position of Member States to incentivise production capacities, as well as diversifying supply chains. In specific cases, those instruments could also support enhanced predictability through multi-annual contracts. The joint procurement of medicines or on Member States’ behalf in the case of the COVID- 19 pandemic, for example, provided a powerful tool to improve access, affordability, and security of supply, was of particular benefit to smaller EU Member States with less economic power.
Amendment 79 #
Proposal for a directive
Recital 52
Recital 52
(52) For the initial marketing authorisation application for medicinal products containing a new active substance, the submission of clinical trials that include as a comparator an evidence- based existing treatment should be incentivised, in order to foster the generation of comparative clinical evidence that is relevant and can accordingly support subsequent health technology assessments and decisions on pricing and reimbursement by Member States. National competent authorities and the Agency should promote, when possible, the use of comparative studies when giving regulatory advise prior to marketing authorization for medicinal products.
Amendment 91 #
Proposal for a directive
Recital 56
Recital 56
(56) Member States have the possibility to waive the condition of launch in their territory for the purpose of the prolongation of data protection for market launch. This can be done through a statement of non-objection to prolong the period of regulatory data protection. This is expected to be the case particularly in situations where launch in a particular Member State is materially impossible or because there are special reasons why a Member State wishes that launch take place later. In the case where a Member State does not react to the application by the marketing authoirsation holder within the deadline provided, it shall be considered that a statement of non objection has been provided and the condition in that Member State should be waived. The Commission should ensure that marketing authorisation holders are not unduly prevented from receiving the incentives for actions beyond their control.
Amendment 103 #
Proposal for a directive
Recital 61
Recital 61
(61) When a compulsory licence has been granted by a relevant authority in the Union to tackle asafeguard public health emergency, regulatory data protection may, if still in force, prevent the effective use of the compulsory licence as they impede the authorisation of generic medicinal products, and thus access to the medicinal products needed to address thea crisis or safeguard public health interests as determined on a Member State level. For this reason, data and market protection should be suspended when a compulsory licence has been issued to tackle asafeguard public health emergency.. Such a suspension of the regulatory data protection should be allowed only in relation to the compulsory licence granted and its beneficiary. The suspension shall comply with the objective, the territorial scope, the duration and the subject matter of the granted compulsory licence.
Amendment 104 #
Proposal for a directive
Recital 61 a (new)
Recital 61 a (new)
(61 a) The WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) provides for a possibility, under conditions, to issue compulsory licences. This provides governments the authority to grant the use of a patented invention without the consent of the patent owner. The Doha Declaration on the TRIPS Agreement and Public Health provides that each WTO Member has not only the right to grant compulsory licences, but also the freedom to determine the grounds upon which such licences are granted.
Amendment 107 #
Proposal for a directive
Recital 62
Recital 62
(62) The suspension of the regulatory data protection should be granted only for the duration of the compulsory licence. A ‘suspension‘ of data and market protection in cases ofto safeguard public health emergency shall mean that data and market protection shall produce no effect in relation to the particular licensee of the compulsory licence while that compulsory licence is in effect. When the compulsory licence ends, the data and market protection shall resume their effect. The suspension should not result in an extension of the original duration.
Amendment 110 #
Proposal for a directive
Recital 63
Recital 63
(63) It is currently possible for applicants for marketing authorisation of generic, biosimilar, hybrid and bio-hybrid medicinal products to conduct studies, trials and the subsequent practical requiremeThe timely entry of generics and biosimilars onto the Union market is importants, necessarotably to obtain cregulatory approvals for those medicinal products during the term of protection of the patent or Supplementary Protection Certificate (SPC) of the reference medicinal product, without this being consideredase competition, to reduce prices and to ensure both the sustainability of national healthcare systems and better access to affordable medicines by patient or SPC infringement. The application of this limited exemption is however fragmented across the Union ands in the EU. The importance of such timely entry has been underlined by the Council in it is considered necessary, in order to facilitate the market entry of generic, biosimilar, hybrid and bio-hybrid medicinal products that rely on a reference medicinal product, to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confinedclusions of 17 June 2016 on strengthening the balance in the pharmaceutical systems in the Union and its Member States. It is currently possible for applicants for marketing authorisation of medicinal products to conduct studies and, trials and other activities needed for the regulatory approval process, health technology assessment and pricing reimbursement request, even subsequent practical requirements necessary to obtain regulatory approvals and variations thereof, withought this may require substantial amounts of test production to demonstrate reliable manufacturing. During the term of protection of the patent or SPC of the reference medicinal product, there can be no commercial use of the resulting final medicinal products obtained for the purposes of the regulatory approval processbeing considered patent or Supplementary Protection Certificate (SPC) infringement.
Amendment 114 #
Proposal for a directive
Recital 63 a (new)
Recital 63 a (new)
(63 a) The application of this limited exemption is however fragmented across the Union and it is considered necessary, in order to facilitate entering the market of any Member State of medicinal products and in particular generic, biosimilar, hybrid and bio-hybrid medicinal products, upon expiry of the corresponding patent or supplementary protection certificate (EU ‘Day-one’ entry) that rely on a reference medicinal product, to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confined to conduct studies, trials and other activities needed for the administrative or regulatory approval process, health technology assessment and and for obtaining pricing and reimbursement, as well as the public and private procurement of medicinal products to be supplied immediately after tbe expiry of the corresponding patent or supplementary protection certificate), even though this may require substantial amounts of test production to demonstrate reliable manufacturing both by the applicant or third party suppliers or service providers. During the term of protection of the patent or SPC of the medicinal product, there can be no placing on the market (within the meaning of the Commission Notice – The ‘Blue Guide’ on the implementation of EU product rules 2022 2022/C 247/01) in that Member State) of the resulting final medicinal products obtained for the purposes of the regulatory approval process.
Amendment 119 #
Proposal for a directive
Recital 64
Recital 64
(64) It will allow all steps required to effectively launch on day-one after patent and SPC protection, inter alia, to conduct studactivities to support regulatory approval, health technology assessment, pricing and reimbursement as well as the manufacture or purchase of patent protected active substances for the purpose of seeking marketing authorisations during that periodaforementioned purposes, contributing to the market entry of generics and biosimilars on day one of loss of the patent or SPC protection.
Amendment 125 #
Proposal for a directive
Recital 65 a (new)
Recital 65 a (new)
(65 a) Under EU law, originator reference product patent protection status is not a criterion to be considered by authorities when granting a marketing authorisation, approving pricing or granting reimbursement status or any regulatory approval for a generic medicinal product, due to its anticompetitive effects. In the context of the goals of the revision of the pharmaceutical framework, it is therefore appropriate to explicitly prohibit patent linkage practices in this context.
Amendment 127 #
Proposal for a directive
Recital 68 a (new)
Recital 68 a (new)
(68 a) In line with European Green Deal and the European Union Strategic Approach to Pharmaceuticals in the Environment, this regulatory framework should also contribute to avoiding potential risks to the environment. The evaluation of the framework showed that strengthened measures to reduce the environmental impact of medicinal products in the would be necessary.
Amendment 130 #
Proposal for a directive
Recital 69 a (new)
Recital 69 a (new)
(69 a) There is strong scientific evidence that the emissions of active substances during manufacturing are a threat to the environment and public health. Therefore, the requirements to protect the environment and public health should be extended in order to cover the entire lifecycle of medicinal products, starting from manufacturing, through use and to disposal.
Amendment 131 #
Proposal for a directive
Recital 70
Recital 70
(70) Marketing authorisation applications for medicinal products in the Union should include an Environmental Risk Assessment (ERA) and risk mitigation measures. The proven efficacy and safety of a medicinal product for human use should remain a top criteria in terms of marketing authorisation, however applicants for marketing authorisation should ensure they complete the ERA in parallel with the marketing authorisation application to be able sufficiently mitigate negative environmental impacts. The ERA should also evaluate the risks to the environment and public health, including antimicrobial resistance that arise in the manufacturing of medicinal products.If the applicant fails to submit a complete or sufficiently substantiated environmental risk assessment or they do not propose risk mitigation measures to sufficiently address the risks identified in the environmental risk assessment, the marketing authorisation should be refused. The ERA should be updated in a timely manner when new data or knowledge about relevant risks become available and risk mitigation measures should be adapted accordingly. Moreover, to take into account the additional exposure resulting from the use of the medicinal product, the ERA should be updated in any case five years after the initial authorisation.
Amendment 136 #
Proposal for a directive
Recital 70 a (new)
Recital 70 a (new)
(70 a) In exceptional cases where the ERA is incomplete due to missing data and this can be duly justified and substantiated by the marketing authorisation holder it may still be placed on the market for reasons in the interest of public health, and with certain post authorisation conditions and oblgiations. Where a medicinal product has been authorised and the ERA is imcomplete for the reason above, the marketing authorisation holder should submit the completed ERA in the timeline agreed with the authorities and deliver upon any other post authorisation obligations.
Amendment 137 #
Proposal for a directive
Recital 70 b (new)
Recital 70 b (new)
(70 b) Detailed requirements for an ERA should be set out in the annexes to this Directive for medicinal products that have been authorised prior to October 2005, i.e. prior to the requirement of submitting an ERA, specific provisions should be introduced to set up a programme for the environmental risk assessement of those products that are identified as potentially harmful to the environment. Moreover, the establishment of a single Union assessment of the environmental properties of active substances for veterinary use by means of an active substance based review (‘monograph’) system could be potential alternative. Such a system should be set up by the Agency following a positive recommendation of the Commission.
Amendment 141 #
Proposal for a directive
Recital 72
Recital 72
(72) The emissions and discharges of antimicrobials to the environment from manufacturing sites may lead to the proliferation of antimicrobial resistance (“AMR”), which is a global concern regardless of where the emissions and discharges take place. Therefore, the ERA scope should be extended to cover the risk of AMR selection during the entire life cycle of antimicrobials, including manufacturing.
Amendment 146 #
Proposal for a directive
Recital 3
Recital 3
(3) This revision is part of the implementation of the Pharmaceutical strategy for Europe and aims to promote innovation, in particular for unmet medical needs, while reducing regulatory burden and the environmental impact of medicines; ensure access to innovative and estensure access to innovative and established medicines for patients and improve affordabilished medicines for patientty of these medicines, with special attention to enhancing security of supply and addressing risks of shortages, taking into account the challenges of the smaller markets of the Union; promote innovation, in particular for unmet medical needs, while reducing regulatory burden and the environmental impact of medicines; and create a balanced and competitive system that keeps medicines affordable for health systems whileand patients while particularly rewarding targeted innovation that improves access to medicinal products in all Member States, where they address unmet medical needs and where preclincial studies and development has taken place in the Union, reinforcing our industrial ecosystems.
Amendment 150 #
Proposal for a directive
Recital 93
Recital 93
(93) To optimise the use of resources for both applicants for marketing authorisation and competent authorities and avoid duplication of assessment of chemical active substances of medicinal products, marketing authorisation applicants should be able to rely on an active substance master file certificate or a monograph of the European Pharmacopeia, instead of submitting the relevant data as required in accordance with Annex II. An active substance master file certificate may be granted by the Agency when the relevant data on the active substance concerned is not already covered by a monograph of the European Pharmacopeia or by another active substance master file certificate. The Commission should be empowered to establish the procedure for the single assessment of an active substance master file. To further optimise the use of resources, the Commission should be empowered to allow use a certification scheme also for additional quality master files i.e. for active substances other than chemical active substances, or for other substances present or used in the manufacture of a medicinal product, required in accordance with Annex II, e.g. in case of novel excipients, adjuvants, radiopharmaceutical precursors and active substance intermediates, when the intermediate is a chemical active substance by itself or used in conjugation with a biological substance.
Amendment 152 #
Proposal for a directive
Recital 100
Recital 100
(100) It is necessary to take account of changes arising as a result of international harmonisation of definitions, terminology and technological developments in the field of pharmacovigilance and digitalisation.
Amendment 153 #
Proposal for a directive
Recital 105
Recital 105
(105) Experience has shown the need to maintain to a certain extent the principle of the use in medicinal products of those colours authorised as food additives. However, it is also appropriate to foresee a specific assessment for the use of the colour in medicines when a food additive is removed from Union list of food additives when it has a functionality beyond colouring. Therefore, in this specific case, EMA should carry out its own assessment for the use of the colour in medicines, taking into account the EFSA opinion and its underlying scientific evidence, as well as any additional scientific evidence and giving particular consideration to the use in medicines. EMA should also be responsible for following any scientific evidence for the colours retained for specific medicine use only. Directive 2009/35/EC should therefore be repealed.
Amendment 154 #
Proposal for a directive
Recital 4
Recital 4
(4) This revision focuses on provisions relevant to achieve its specific objectives; therefore it covers all but provisions concerning falsified medicines, homeopathic and traditional herbal medicines. Nevertheless, for the sake of clarity, it is necessary to replace Directive 2001/83/EC of the European Parliament and of the Council38[1] with a new Directive. The provisions on falsified medicines, homeopathic medicines and traditional herbal medicines are therefore maintained in this Directive without changing their substance compared to previous harmonisations. However, in view of the changes in the governance of the Agency, the Herbal Committee is replaced by a working group. _________________ 38 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
Amendment 154 #
Proposal for a directive
Recital 109
Recital 109
(109) There may be cases where manufacturing or testing steps of medicinal products need to take place in sites close to patients, for example advanced therapy medicinal products with short shelf-life. In such cases, these manufacturing or testing steps may need to be decentralised to multiple sites to reach patients across the Union. When the manufacturing or testing steps are decentralised, they should be carried out under the responsibility of the qualified person of an authorised central site. Additionally, in order to ensure smooth functioning of decentralised sites under this framework with the activities relevant for other Union legal frameworks competent authorities of Member States supervising the decentralised site should coordinate their acitivities and supervisory tasks with the relevant authorities responsible for the supervision of the manufacturing or testing activities under other Union acts. The decentralised sites should not require a separate manufacturing authorisation from the one granted to the relevant central site but should be registered by the competent authority of the Member State in which the decentralised site is established. In the case of medicinal products containing, consisting or derived from autologous SoHO, the decentralised sites have to be registered as a SoHO entity as defined in and pursuant to [SoHO Regulation] for the activities of donor review and eligibility assessment, donor testing and collection, or just for collection in the case of products manufactured for autologous use.
Amendment 158 #
Proposal for a directive
Recital 6
Recital 6
(6) The regulatory framework for medicinal products for human use should also take into account the needs of the undertakings in the pharmaceutical sector and trade in medicinal products within the Union, without jeopardising the quality, safety and efficacy of medicinal products.
Amendment 163 #
Proposal for a directive
Recital 129
Recital 129
(129) Where Member States decide thatshould make the package leaflet should be made available in principle onlyavailable electronically, and they should also ensure that a paper version of the package leaflet is to be made available on demand and without additonal cost to patientsprovided.. They should also ensure that the information in digital format is easily accessible to all patients, for instance by including in the outer packaging of the product a digitally readable barcode, which would direct the patient to the electronic version of the package leaflet. However, Member States may choose to use only electronic leaflets for a limited range of medicinal products dispensed to in hospital patients where the provision of medical information can be ensured by health professional. The Commission should be empowered in the future to, by means of delegated acts, transition completely to electronic leaflets.
Amendment 165 #
Proposal for a directive
Recital 131
Recital 131
(131) To ensure a high level of transparency of public and private support to the research and development of medicinal products, the reporting of public and private contribution for the development of a particular medicinal product should be a requirement for all medicines. Given however the practical difficulty to identify how indirect public funding instruments, such as tax advantages, have supported a particular product, the reporting obligation should only concern the direct public finanThis should apply also to any independent legal entity from which it obtained a license in relation to the medicinal product in its previous phases of development. The information should be dissagregated to each stage of drug research and development, basic research, pre-clinical research, phase I, II, III of the clinical investigation of the medicinal support, such as direct grants or contractproduct; as well as post-market studies. Therefore, the provisions of this Directive ensure, without prejudice to the rules on the protection of confidential and personal data, transparency regarding any direct and indirect financial support received from any public authority or public body to carry out any activities for the research and development of medicinal products.
Amendment 166 #
Proposal for a directive
Recital 11
Recital 11
(11) The Directive should work in synergy with the Regulation to enable innovation and promote competitiveness of the Union pharmaceutical industry, in particular SMEs. In this respect a balanced system of incentives is proposed that rewards innovation especially in areas of unmet medical need and, innovation that reaches patients and improves access across the Union and innovation that stems from preclinical studies developed in the Union. To make the regulatory system more efficient and innovation- friendly the Directive also aims at reducing administrative burden and simplifying procedures for undertakings.
Amendment 167 #
Proposal for a directive
Recital 11 a (new)
Recital 11 a (new)
(11 a) It is however, difficult to establish a direct link between incentives offered nowadays at Union level and Union competitiveness in the pharmaceutical sphere vis-à-vis third country based companies. While incentives can make the EU a more attractive market for industry, they remain agnostic to medicines´ geographical origin. Medicines originating from third country based companies are eligible to all EU incentives. Equally, EU based innovative companies can benefit from incentives elsewhere if they sell their products in these markets. Therefore a reduction in the regulatory data protection period should not harm EU companies vis-à-vis non EU companies coming to the EU market in terms of competitiveness.
Amendment 169 #
Proposal for a directive
Recital 11 b (new)
Recital 11 b (new)
(11 b) However, to improve research and development in the pharmaceutical sphere stemming from the Union, as well as contributing to open EU strategic autonomy, it could be beneficial to establish a direct link between preclinical studies conducted in the Union and an incentive pronlonging data protection for a medicinal product. Therefore, an incentive to extend the data protection period is proposed where a company can demonstrate this.
Amendment 169 #
Proposal for a directive
Recital 133
Recital 133
(133) In order to ensure a harmonised and consistent reporting of public and private contribution for the development of a particular medicinal products, the Commission should be able to adopt implementing acts to clarify the principles and format that the marketing authorisation holder should adhere to when reporting this information.
Amendment 170 #
Proposal for a directive
Recital 135
Recital 135
(135) Advertising, even of medicinal products not subject to a prescription, could affect public health and distort competition. Therefore, advertising of medicinal products should meet certain criteria ensuring high standards of protection. Persons qualified to prescribe, administer or supply medicinal products can properly evaluate the information available in advertising because of their knowledge, training and experience. The advertising of medicinal products to persons who cannot properly assess the risk associated with their use may lead to medicinal product misuse or overconsumption which is liable to harm public health. Therefore advertisement to the general public of medicinal products that are available only on medical prescription should be prohibited. Furthermore, distribution of samples free of charge to the general public for promotional ends is to be prohibited, also teleshopping for medicinal products shall be prohibited pursuant to Directive 2010/13/EU of the European Parliament and of the Council[65 ]. It should be possible within certain restrictive conditions to provide samples of medicinal products free of charge to persons qualified to prescribe or supply them so that they can familiarise themselves with new products and acquire experience in dealing with them. _________________ 65 Directive 2010/13/EU of the European Parliament and of the Council of 10 March 2010 on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the provision of audiovisual media services (Audiovisual Media Services Directive) (OJ L 095 15.4.2010, p. 1).
Amendment 173 #
Proposal for a directive
Article 1 – paragraph 4
Article 1 – paragraph 4
4. In cases where, taking into account all its characteristics, questions arise as to the regulatory status of product or a product falls within the definition of a ‘medicinal product’ and within the definition of a product covered by other Union law and there is a conflict between this Directive and other Union law, the provisions of this Directive shall prevailegislation, the Agency and the advisory and regulatory bodies established in other Union legislation shall consult as relevant, in order to find consensus on the regulatory status of the product or the application of Union law to the product. Where the Agency and the advisory and regulatory bodies established in other Union legislation cannot reach consensus on the regulatory status or Union law applicable to the product: (a) The Commission shall be empowered to take a decision on the regulatory status or the Union law applicable to the law in question, duly taking into account the relevant opinions and conclusions of the Agency and other advisory bodies and regulatory bodies established under Union law. This decision along with the supporting analysis and conclusion shall be made publicly available. (b) For transparency purposes, the respective opinions and conclusions of the Agency and the relevant advisory and regulatory bodies should be made publicly available.
Amendment 174 #
Proposal for a directive
Recital 15
Recital 15
(15) In order to take account both of the emergence of new therapies and of the growing number of so-called ‘borderline’ products between the medicinal product sector and other sectors, certain definitions and derogations should be modified, so as to avoid any doubt as to the applicable legislation. With the same objective of clarifying situations when a product fully falls within the definition of a medicinal product and also meet the definition of other regulated products, the rules for medicinal products under this Directive applyAgency and the advisory and regulatory bodies established in other Union legislation, as relevant, should engage in consultations, in order to find consensus on the regulatory status of the product or the application of Union law to the borderline product in question. Where necessary, the Commission should be empowered to take the decision on the regulatory status or applicability of legal rules to the borderline product,the assessment and conclusions of which should be made publicly available. Furthermore, for transparency purposes, the respective opinions and conclusions of the Agency and the other advisory and regulatory bodies established in other Union legislation should be made publicly available. Furthermore, to ensure the clarity of applicable rules, it is also appropriate to improve the consistency of the terminology of the pharmaceutical legislation and clearly indicate the products excluded from the scope of this Directive.
Amendment 174 #
Proposal for a directive
Article 1 – paragraph 6
Article 1 – paragraph 6
Amendment 176 #
Proposal for a directive
Recital 16
Recital 16
(16) The new definition for a substance of human origin (SOHO) by the [SoHO Regulation] covers any substance collected from the human body in whatever manner, whether it contains cells or not and regardless of whether it meets the definition of ‘blood’, ‘tissue’ or ‘cell’, for example human breast milk, intestinal microbiota and any other SoHO that may be applied to humans in the future. Such substances of human origin, other than tissues and cells, may become SoHO derived medicinal products, other than ATMPs, when the SoHO is subject to an industrial process involving systematisation, reproducibility and operations performed on a routine basis or batch-wise resulting in a product of standardised consistency. When a process concerns extraction of an active ingredient from the SoHO, other than tissues and cells, or a transformation of a SoHO, other than tissues and cells, by changing its inherent properties, this should also be considered a SoHO derived medicinal product. When a process concerns concentratpooling, separating or isolating elements in the preparation of blood componentsSoHO, as well as methods to reduce, inactivate or eliminate microbes to enhance micro-biological quality, this should not be considered as changing their inherent properties.
Amendment 177 #
Proposal for a directive
Article 1 – paragraph 10
Article 1 – paragraph 10
Amendment 178 #
Proposal for a directive
Recital 17 a (new)
Recital 17 a (new)
(17 a) For SoHO derived medicinal products, each Member State shoud ensure through public service obligations that those manufacturers provide an appropriate and continuous supply of SoHO derived medicinal products to patients in their territory. Member States should negotiate fair and transparent prices for SoHO derived medicinal products that are derived from altruistic and unpaid donations. Member States should also ensure that affordable SoHO derived medicinal products are available to patients in their territory. In this regard, manufacturers of these products should report annually to authorities on the quantities prepared and the amount supplied for public use.
Amendment 179 #
Proposal for a directive
Article 2 – paragraph 1
Article 2 – paragraph 1
1. By way of derogation from Article 1(1), only this Article shall apply to advanced therapy medicinal products prepared on a non-routine basis in accordance with the requirements set in paragraph 3 and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient (‘advanced therapy medicinal products prepared under hospital exemption’).
Amendment 184 #
Proposal for a directive
Article 2 – paragraph 3
Article 2 – paragraph 3
3. Member States shall ensure that advanced therapy medicinal products prepared under hospital exemption comply with the requirements equivalent to the good manufacturing practices and traceability for advanced therapy medicinal products referred to in Articles 5 and 15 of Regulation (EC) No 1394/2007 [69] respectively, and with pharmacovigilance requirements equivalent to those provided for at Union level pursuant to [revised Regulation (EC) No 726/2004]. _________________ 69 Regulation (EC) No 1394/2007 of the European ParliamentThis shall include site inspections and GMP CPF accreditation, as well as traceability and pharmacovigilance plans and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 1)evaluation of the preclinical and clinical data generated by the applicant.
Amendment 185 #
Proposal for a directive
Recital 18
Recital 18
(18) Advanced therapy medicinal products that are prepared on a non- routine basis according to specific quality standards, and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient, should be excluded from the scope of this Directive whilst at the same time ensuring that relevant Union rules related to quality and safety are not undermined (‘hospital exemption’). Experience has shown that there are great differences in the application of hospital exemption among Member States. To improve the application of hospital exemption this Directive introduces measures for collection, reporting of data as well as review of these data yearly by the competent authorities and their publication by the Agency in a repository. Furthermore, the Agency should provide a report on the implementation of hospital exemption on the basis of contributions from Member States in order to examine whether an adapted framework should be established for certain less complex ATMPs that have been developed and used under the hospital exemption. When an authorisation for the manufacturing and use of an ATMP under hospital exemption is revoked because of safety concerns, the relevant competent authorities shall inform the competent authorities of other Member States.
Amendment 185 #
Proposal for a directive
Article 2 – paragraph 4
Article 2 – paragraph 4
4. Member States shall ensure that data on the use, safety and the efficacy of advanced therapy medicinal products prepared under hospital exemption is collected and reported by the hospital exemption approval holder to the competent authority of the Member State at least annually. The competent authority of the Member State shall review such data and shall verify the compliance of advanced therapy medicinal products prepared under hospital exemption with the requirements referred to in paragraph 3set the requirements for the collection and reporting of such data, in a structured and standarized way that allows obtaining more robust, reliable and comparable results and conclusions. The competent authority of the Member State shall review such data and shall verify the compliance of advanced therapy medicinal products prepared under hospital exemption with the requirements referred to in paragraph 3. Competent authorities shall ensure that sufficient scientific and regulatory advice is provided to non-profit and academic institutions in order to ensure appropriate reporting mechanisms.
Amendment 186 #
Proposal for a directive
Recital 18 a (new)
Recital 18 a (new)
(18 a) Hospital exemption pathway is a crucial way of providing patients with access to innovative and affordable treatments that may not be available through other channels. Any limitations to this pathway should avoided, but only based on efficacy, quality and safety criteria, without time restrictions or restrictions on quantities. Competent authorities should guarantee that the authorisation of other products through the centralized procedure does not adversely affect the activities and responsibilities of developers functioning under the hospital exemption. The Agency, as well as competent authorities at the national level, should support academic institutions and other non-profit entities through the requirements of the hospital exemption clause and, when adequate, should provide guidance through centralised marketing authorisation procedure.
Amendment 189 #
Proposal for a directive
Article 2 – paragraph 4 a (new)
Article 2 – paragraph 4 a (new)
4 a. Competent authorities shall ensure that sufficient scientific and regulatory advice is provided to non-profit and academic institutions in order to assist them through the requirements of the hospital exemption clause. In cases where a product under hospital exemption becomes a suitable candidate to begin a centralized marketing authorization procedure, competent authorities shall assist non-profit and academic institutions also through this authorization process.
Amendment 194 #
Proposal for a directive
Recital 24
Recital 24
(24) It is therefore necessary to introduce a requirement for new medicinal products or when developing paediatric indications of already authorised products covered by a patent or a supplementary protection certificate to present either the results of studies in the paediatric population in accordance with an agreed paediatric investigation plan or proof of having obtained a waiver or deferral, at the time of filing a marketing authorisation application or an application for a new therapeutic indication, new pharmaceutical form or new route of administration. However, in order to avoid exposing children to unnecessary clinical trials or due to the nature of the medicinal products, that requirement should not apply to generics or similar biological medicinal products and medicinal products authorised through the well-established medicinal use procedure, nor to homeopathic medicinal products and traditional herbal medicinal products authorised through the simplified registration procedures of this Directive.
Amendment 194 #
Proposal for a directive
Article 2 – paragraph 6
Article 2 – paragraph 6
6. The competent authority of the Member State shall transmit the data related to the use, safety and efficacy of an advanced therapy medicinal product prepared under the hospital exemption approval to the Agency annually. The Agency shall, in collaboration with the competent authorities of Member States and the Commission, set up and maintain a repository of that data, as well as of information on the authorisation, suspension or withdrawal of hospital exemption approvals, reimbursement prices, and public and private contributions to the development of the product; which shall be updated regularly.
Amendment 195 #
Proposal for a directive
Recital 27
Recital 27
(27) Certain particulars and documentation that are normally to be submitted with an application for a marketing authorisation should not be required if a medicinal product is a generic medicinal product or a similar biological medicinal product (biosimilar) that is authorised or has been authorised in the Union. Both generic and biosimilar medicinal products are important to ensure access of medicinal products to a wider patient population at more affordable prices and create a competitive internal market . In a joint statement authorities of the Member States confirmed that the experience with approved biosimilar medicinal products over the past 15 years has shown that in terms of efficacy, safety and immunogenicity they are comparable to their reference medicinal product and are therefore interchangeable and can be used instead of its reference product (or vice versa) or replaced by another biosimilar of the same reference product.
Amendment 197 #
Proposal for a directive
Recital 31
Recital 31
(31) Directive 2010/63/EU of the European Parliament and of the Council43[1] lays down provisions on the protection of animals used for scientific purposes based on the principles of replacement, reduction and refinement. Any study involving the use of animals, which provides essential information on the quality, safety and efficacy of a medicinal product, should take into account those principles of replacement, reduction and refinement, where they concern the care and use of live animals for scientific purposes, and should be undertaken as a last resort and be optimised in order to provide the most satisfactory results whilst using the minimum number of animals. The marketing authorisation applicant should not carry out animal tests in case scientifically satisfactory non-animal testing methods are available. Where scientifically satisfactory non-animal testing methods are not available, applicants that use animal testing should ensure that the principle of replacement, reduction and refinement of animal testing for scientific purposes has been with regard to any animal study conducted for the purpose of supporting the application. The procedures of such testing should be designed to avoid causing pain, suffering, distress or lasting harm to animals and should follow the available EMA and ICH guidelines. In particular, the marketing authorisation applicant and the marketing authorisation holder should take into account the principles laid down in Directive 2010/63/EU, including, where possible, use new approach methodologies in place of animal testing. These can include but are not limited to: in vitro models, such as microphysiological systems including organ-on-chips, (2D and 3D-) cell culture models, organoids and human stem cells-based models; in silico tools or read-across models. _________________ 43[1] Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).
Amendment 197 #
Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 – point b
Article 2 – paragraph 7 – subparagraph 1 – point b
(b) the format for collection and reporting of data referred to in paragraph 3 and 4;
Amendment 200 #
Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 – point d
Article 2 – paragraph 7 – subparagraph 1 – point d
(d) the modalities for preparation and use of advanced therapy medicinal products under hospital exemption on a non-routine basis.;
Amendment 201 #
Proposal for a directive
Recital 32
Recital 32
(32) Procedures should be in place to facilitate joint animal testing, wherever possible, in order to avoid unnecessary duplication of testing using live animals covered by Directive 2010/63/EU. Marketing authorisation applicants and marketing authorisation holders should make all efforts to reuse animal study results and make the results obtained from animal studies publicly available. For abridged applications marketing authorisation applicants should refer to the relevant studies conducted for the reference medicinal product.
Amendment 201 #
Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 – point d a (new)
Article 2 – paragraph 7 – subparagraph 1 – point d a (new)
(d a) the modalities of guidance for academic and other not-for-profit entities through the requirements of the hospital exemption clause and the centralised marketing authorisation procedure.
Amendment 203 #
Proposal for a directive
Recital 39
Recital 39
(39) In the interest of as broad as possible access to medicinal products, a Member State that has an interest in receiving access to a particular medicinal product undergoing authorisation through the decentralised and mutual recognition procedures should be able to opt-into that procedure. A Member State who did not join the initital application for the decentralised procedure within 30 days of the sumission of the application should still have a second opportunity to opt into the procedure at a later point, in this case they should immeditately inform the applicant and the competent authority of the reference Member State for the decentralised procedure.
Amendment 206 #
Proposal for a directive
Article 2 – paragraph 8 a (new)
Article 2 – paragraph 8 a (new)
8 a. Competent authorities shall guarantee that the authorization of products through the centralized procedure shall not adversely affect the activities and responsibilities of developers functioning under the hospital exemption as outlined in paragraphs 3 and 4.
Amendment 207 #
Proposal for a directive
Article 3 – paragraph 1 – subparagraph 1
Article 3 – paragraph 1 – subparagraph 1
A Member State may, in order to fulfil special needs, exclude from the scope of this Directive medicinal products supplied in response to a bona fide unsolicited order, prepared in accordance with the specifications of an authorised healthcare professional and for use by an individual patient under their direct personal responsibility, or prepared in accordance with the specifications of a competent authority. However, in such case Member States shall encourage healthcare professionals and patients to report data on the safety of the use of such products to the competent authority of the Member State in accordance with Article 97.
Amendment 209 #
Proposal for a directive
Recital 44
Recital 44
(44) As regards access to medicinal products, previous amendments to the Union pharmaceutical legislation have addressed this issue by providing for accelerated assessment of marketing authorisation applications or by allowing conditional marketing authorisation for medicinal products for unmet medical need. While these measures accelerated the authorisation of innovative and promising therapies, these medicinal products do not always reach the patient and patients in the Union still have different levels of access to medicinal products. Patient access to medicinal products depends on many factors. Marketing authorisation holders are not obliged to market a medicinal product in all Member States; they may decide not to market their medicinal products in, or withdraw them from, one or more Member States, often due to profitability considerations. National pricing and reimbursement policies, the size of the population, the organisation of health systems, and national administrative procedures are other factors influencing market launch and patient access.
Amendment 211 #
Proposal for a directive
Recital 45
Recital 45
(45) Addressing unequal patient access and affordability of medicinal products has become a key priority of the Pharmaceutical Strategy for Europe, as also highlighted by Council conclusions45[1] and a resolution of the European Parliament46 [2]. Member States called for revised mechanisms and incentives for development of medicinal products tailored to the level of unmet medical need, while ensuring health system sustainability, patient access and availability of affordable medicinal products in all Member States. _________________ 45 Council conclusions on strengthening the balance in the pharmaceutical systems in the EU and its Member States, (OJ C, C/269, 23.07.2016, p. 31). Council Conclusions on Access to medicines and medical devices for a Stronger and Resilient EU, (2021/C 269 I/02). 46 European Parliament resolution of 2 March 2017 on EU options for improving access to medicine (2016/2057(INI)) Shortages of medicines, 2020/2071(INI)Putting in place tolls to evaluate access to medicines at a Union level is key to follow-up on the results achieved through incentives.
Amendment 214 #
Proposal for a directive
Article 4 – paragraph 1 – point 10 a (new)
Article 4 – paragraph 1 – point 10 a (new)
(10 a) 'clock stop’ means a period of time during which the evaluation of a medicine is officially stopped, while the applicant prepares responses to questions from the regulatory authority. The clock resumes when the applicant has sent its responses.
Amendment 216 #
Proposal for a directive
Recital 46
Recital 46
(46) Access also comprises affordability. In this regard, the Union pharmaceutical legislation respects the competence of the Member States in terms of pricing and reimbursement. In a complementary manner, it aims to have a positive impact on affordability and sustainability of health systems with measures that support competition from generic and biosimilar medicinal products. The competition from generic and biosimilar medicinal products should also, in turn, increase patient access to medicinal products.
Amendment 221 #
(48) While pricing and reimbursement decisions are a Member State competence, the Pharmaceutical Strategy for Europe announced actions to support cooperation of Member States to improve affordability. The Commission has transformed the group of National Competent Authorities on Pricing and Reimbursement and public healthcare payers (NCAPR) from an ad- hoc forum to a continuous voluntary cooperation with the aim to exchange information and best practices on pricing, payment and procurement policies to improve the affordability and cost- effectiveness of medicines and health system’s sustainability. The Commission is committed to stepping up this cooperation and further supporting information exchange among national authorities, including on public procurement of medicines, while fully respecting the competences of Member States in this area. Such procurement efforts should be based on the principle of the ‘most economically advantageous tender’ (‘MEAT’ criteria), which aims to ensure the best value for money rather than most economically advantageous product. Such an approach could also help in defining adequate supply in relation to critical medicines and, thereby, compensate and incentivise industry, and support the application of these criteria in a coordinated way, at EU level. Predictability of supply would also be helped by medium-term contractual incentives to diversify and attract the next generation of manufacturing investments in Europe. The Commission may also invite NCAPR members to participate in deliberations of the Pharmaceutical Committee on topics that may have an impact on pricing or reimbursement policies, such as the market launch incentive.
Amendment 228 #
Proposal for a directive
Recital 49 a (new)
Recital 49 a (new)
(49 a) Practices in procurement procedures for medicines differ between Member States and long-term availability is rarely a primary consideration. The 2014 Procurement Directive encourages a more strategic approach through award criteria, including criteria beyond price. Using the lowest price as the main selection criterion may reduce incentives for the industry to build for long-term supply in the EU. At the same time, vulnerability may be increased when public procurement procedures award contracts to a single company. Where challenges with access to a critical medicine and related affordability may be an issue, Member States can work together to increase buying power. Joint procurement between Member States can act as a powerful tool to improve access, affordability and security of supply, of particular benefit in smaller EU markets. This can improve the negotiating position of Member States to incentivise production capacities, as well as diversifying supply chains. In specific cases, those instruments could also support enhanced predictability through multi-annual contracts. The joint procurement of medicines or on Member States’ behalf in the case of the COVID- 19 pandemic, for example, provided a powerful tool to improve access, affordability, and security of supply, was of particular benefit to smaller EU Member States with less economic power.
Amendment 229 #
Proposal for a directive
Article 4 – paragraph 1 – point 33
Article 4 – paragraph 1 – point 33
(33) ‘environmental risk assessment’ means the evaluation of the risks and potential risks to the environment, or risks to public health, posed by the release of the medicinal product in the environment from the use, manufacturing and disposal of the medicinal product and the identification of risk prevention, limitation and mitigation measures. For medicinal product with an antimicrobial mode of action, the ERA also encompasses an evaluation of the risk for antimicrobial resistance selection in the environment due to the manufacturing, use and disposal of that medicinal product;
Amendment 230 #
Proposal for a directive
Recital 50
Recital 50
Amendment 240 #
Proposal for a directive
Article 4 – paragraph 1 – point 70 a (new)
Article 4 – paragraph 1 – point 70 a (new)
(70 a) Decentralised manufacturing means a production model where manufacturing of medicinal products needs to take place in local sites close to patients.
Amendment 241 #
Proposal for a directive
Article 5 – paragraph 2
Article 5 – paragraph 2
2. When an initial marketing authorisation has been granted in accordance with paragraph 1, any development concerning the medicinal product covered by the authorisation such as additional therapeutic indication, strengths, pharmaceutical forms, administration routes, presentations, as well as any variations of the marketing authorisation shall also be granted an authorisation in accordance with paragraph 1 or be included in the initial marketing authorisation. All those marketing authorisations as well as those obtained by this marketing authorisation holder according to article 9 to 12 shall be considered as belonging to the same global marketing authorisation, in particular for the purpose of the marketing authorisations applications under Articles 9 to 12, including as regards the expiry of the regulatory data protection period for applications using a reference medicinal product.
Amendment 243 #
Proposal for a directive
Article 6 – paragraph 5 – subparagraph 1 – point a a (new)
Article 6 – paragraph 5 – subparagraph 1 – point a a (new)
(a a) in the absence of comparative studies, a justification to substantiate the reasons why the above mentioned studies could not be conducted;
Amendment 245 #
Proposal for a directive
Article 6 – paragraph 7 – subparagraph 2
Article 6 – paragraph 7 – subparagraph 2
The marketing authorisation applicant shall not carry out animal testing in case scientifically satisfactory non-animal testing methods are available. The marketing authorisation applicant shall not carry out animal tests in case scientifically satisfactory non-animal testing methods are available. Where scientifically satisfactory non-animal testing methods are not available, applicants that use animal testing shall ensure that the principle of replacement, reduction and refinement of animal testing for scientific purposes has been applied in compliance with Directive 2010/63/EU with regard to any animal study conducted for the purpose of supporting the application.
Amendment 246 #
Proposal for a directive
Article 9 – paragraph 3 – subparagraph 1
Article 9 – paragraph 3 – subparagraph 1
Paragraph 1 shall also apply if the reference medicinal product has not been authorised in the Member State in which the application for the generic medicinal product is submitted. In this, unless the applicant of the generic product is also the MAH or a related company of the reference medicinal product. In the latter case the complete dossier should be submitted. In the former case,, the applicant shall indicate in the application the name of the Member State in which the reference medicinal product is or has been authorised. At the request of the competent authority of the Member State in which the application is submitted, the competent authority of the other Member State shall transmit within a period of one month a confirmation that the reference medicinal product is or has been authorised together with the full composition of the reference medicinal product and if necessary, any other relevant documentation.
Amendment 247 #
Proposal for a directive
Recital 52
Recital 52
(52) For the initial marketing authorisation application for medicinal products containing a new active substance, the submission of clinical trials that include as a comparator an evidence- based existing treatment should be incentivised, in order to foster the generation of comparative clinical evidence that is relevant and can accordingly support subsequent health technology assessments and decisions on pricing and reimbursement by Member States. National competent authorities and the Agency should promote, when possible, the use of comparative studies when giving regulatory advice prior to marketing authorization for medicinal products.
Amendment 247 #
Proposal for a directive
Article 10 – paragraph 1
Article 10 – paragraph 1
In cases where the medicinal product does not fall within the definition of a generic medicinal product or has changes in strength, pharmaceutical form, route of administration or therapeutic indications, compared to the reference medicinal product, the results of the appropriate non- clinical tests orand clinical studies shall be provided to the competent authorities to the extent necessary to establish a scientific bridge to the data relied upon ino the extent necessary to demonstrate (essential) similarity to the marketing authorisation for the reference medicinal product, and to demonstrate the safety and efficacy profile of the hybrid medicinal product in any additional indication.
Amendment 251 #
Proposal for a directive
Article 13 – paragraph 1
Article 13 – paragraph 1
In cases where no reference medicinal product is or has been authorised for the active substance of the medicinal product concerned, the applicant shall, by way of derogation from Article 6(2), not be required to provide the results of non- clinical tests or clinical studies if the applicant can demonstrate that the active substances of the medicinal product have been in well-established medicinal use within the Union for the same therapeutic use and route of administration and for at least ten years, with recognised efficacy and an acceptable level of safety in terms of the conditions set out in Annex II. In that event, the test and trial results shall be replaced by appropriate bibliographic data in the form of scientific literature and demonstration that this literature is relevant for the applied product.
Amendment 257 #
Proposal for a directive
Recital 56
Recital 56
(56) Member States have the possibility to waive the condition of launch in their territory for the purpose of the prolongation of data protection for market launch. This can be done through a statement of non-objection to prolong the period of regulatory data protection. This is expected to be the case particularly in situations where launch in a particular Member State is materially impossible or because there are special reasons why a Member State wishes that launch take place later. In the case where a Member State does not react to the application by the marketing authorisation holder within the deadline provided, it should be considered that a statement of non objection has been provided and the condition in that Member State should be waived. The Commission should ensure that marketing authorisation holders are not unduly prevented from receiving the incentives for actions beyond their control.
Amendment 264 #
Proposal for a directive
Article 17 – paragraph 1 – point b
Article 17 – paragraph 1 – point b
(b) a description of the special information requirements outlined in Article 69 and listed in Annex I, for prior review and approval by the competent authority.
Amendment 265 #
Proposal for a directive
Article 17 – paragraph 2
Article 17 – paragraph 2
2. The competent authority mayshall impose obligations on the marketing authorisation holder if it finds the risk mitigation measures contained in the antimicrobial stewardship plan unsatisfactory.
Amendment 272 #
Proposal for a directive
Recital 61
Recital 61
(61) When a compulsory licence has been granted by a relevant authority in the Union to tackle asafeguard public health emergency,,[A1] regulatory data protection may, if still in force, prevent the effective use of the compulsory licence as they impede the authorisation of generic medicinal products, and thus access to the medicinal products needed to address thea crisis or safeguard public health interests as determined on a Member State level. For this reason, data and market protection should be suspended when a compulsory licence has been issued to tackle asafeguard public health emergency.. Such a suspension of the regulatory data protection should be allowed only in relation to the compulsory licence granted and its beneficiary. The suspension shall comply with the objective, the territorial scope, the duration and the subject matter of the granted compulsory licence.
Amendment 273 #
Proposal for a directive
Recital 61 a (new)
Recital 61 a (new)
(61 a) The WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) provides for a possibility, under conditions, to issue compulsory licences. This provides governments the authority to grant the use of a patented invention without the consent of the patent owner. The Doha Declaration on the TRIPS Agreement and Public Health provides that each WTO Member has not only the right to grant compulsory licences, but also the freedom to determine the grounds upon which such licences are granted.
Amendment 273 #
Proposal for a directive
Article 22 – paragraph 1
Article 22 – paragraph 1
1. When preparing the environmental risk assessment (‘ERA’) to be submitted pursuant to Article 6(2), the applicant shall take into account the scientific guidelines on the environmental risk assessment of medicinal products for human use as referred to in paragraph 6, or provide the duly justified reasons for any divergence from the scientific guidelines to the Agency or, as appropriate to the competent authority of the Member State concerned, in a timely manner. Where available, the applicant shall take into account existing ERAs performed under other Union legislation.
Amendment 276 #
Proposal for a directive
Recital 62
Recital 62
(62) The suspension of the regulatory data protection should be granted only for the duration of the compulsory licence. A ‘suspension‘ of data and market protection in cases ofto safeguard public health emergency shall mean that data and market protection shall produce no effect in relation to the particular licensee of the compulsory licence while that compulsory licence is in effect. When the compulsory licence ends, the data and market protection shall resume their effect. The suspension should not result in an extension of the original duration.
Amendment 278 #
Proposal for a directive
Article 22 – paragraph 2 – introductory part
Article 22 – paragraph 2 – introductory part
2. The ERA shall evaluate the possible risks to the environment due to the use and disposal of the medicinal product according to the requirements referred to in Annex II . It shall indicate whether the medicinal product or any of its ingredients or other constituents is one of the following substances according to the criteria of Annex I to the Regulation (EC) No 1272/2008:
Amendment 284 #
Proposal for a directive
Recital 63
Recital 63
(63) It is currently possible for applicants for marketing authorisation of generic, biosimilar, hybrid and bio-hybrid medicinal products to conduct studies, trials and the subsequent practical requiremeThe timely entry of generics and biosimilars onto the Union market is importants, necessarotably to obtain cregulatory approvals for those medicinal products during the term of protection of the patent or Supplementary Protection Certifiase competition, to reduce prices and to ensure both the sustainability of national healthcatre (SPC) of the reference medicinal product, without this being consideredsystems and better access to affordable medicines by patient or SPC infringement. The application of this limited exemption is however fragmented across the Union ands in the EU. The importance of such timely entry has been underlined by the Council in it is considered necessary, in order to facilitate the market entry of generic, biosimilar, hybrid and bio-hybrid medicinal products that rely on a reference medicinal product, to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confinedclusions of 17 June 2016 on strengthening the balance in the pharmaceutical systems in the Union and its Member States. It is currently possible for applicants for marketing authorisation of medicinal products to conduct studies and, trials and other activities needed for the regulatory approval process, health technology assessment and pricing reimbursement request, even subsequent practical requirements necessary to obtain regulatory approvals and variations thereof, withought this may require substantial amounts of test production to demonstrate reliable manufacturing. During the term of protection of the patent or SPC of the reference medicinal product, there can be no commercial use of the resulting final medicinal products obtained for the purposes of the regulatory approval processbeing considered patent or Supplementary Protection Certificate (SPC) infringement.
Amendment 285 #
Proposal for a directive
Article 22 – paragraph 2 a (new)
Article 22 – paragraph 2 a (new)
2 a. With regards to risks resulting from manufacturing the ERA shall provide information on discharged and emissions of the active susbtance(s) and other environmentally relevant susbtances according to the requirements referred to in Annex II.
Amendment 288 #
Proposal for a directive
Article 22 – paragraph 3
Article 22 – paragraph 3
3. The applicant shall also include in the ERA risk mitigation measures to avoid or where it is not possible, limit emissions to air, water and soil of pollutants listed in Directive 2000/60/EC, Directive 2006/118/EC, Directive 2008/105/EC and Directive 2010/75/EU or in the cases where risks to the environment are identified in the scientific guidelines drawn up by the Agency on the ERA requirements for medicinal products for human use as referred to in paragraph 5. The applicant shall provide detailed explanation that the proposed mitigation measures are appropriate and sufficient to address the identified risks to the environment.
Amendment 289 #
Proposal for a directive
Recital 63 a (new)
Recital 63 a (new)
(63 a) The application of this limited exemption is however fragmented across the Union and it is considered necessary, in order to facilitate entering the market of any Member State of medicinal products and in particular generic, biosimilar, hybrid and bio-hybrid medicinal products, upon expiry of the corresponding patent or supplementary protection certificate (EU ‘Day-one’ entry) that rely on a reference medicinal product, to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confined to conduct studies, trials and other activities needed for the administrative or regulatory approval process, health technology assessment and and for obtaining pricing and reimbursement, as well as the public and private procurement of medicinal products to be supplied immediately after tbe expiry of the corresponding patent or supplementary protection certificate), even though this may require substantial amounts of test production to demonstrate reliable manufacturing both by the applicant or third party suppliers or service providers. During the term of protection of the patent or SPC of the medicinal product, there can be no placing on the market (within the meaning of the Commission Notice – The ‘Blue Guide’ on the implementation of EU product rules 2022 2022/C 247/01) in that Member State) of the resulting final medicinal products obtained for the purposes of the regulatory approval process.
Amendment 297 #
Proposal for a directive
Recital 64
Recital 64
(64) It will allow all steps required to effectively launch on day-one after patent and SPC protection, inter alia, to conduct studactivities to support regulatory approval, health technology assessment, pricing and reimbursement as well as the manufacture or purchase of patent protected active substances for the purpose of seeking marketing authorisations during that periodaforementioned purposes, contributing to the market entry of generics and biosimilars on day one of loss of the patent or SPC protection.
Amendment 298 #
Proposal for a directive
Article 22 – paragraph 5
Article 22 – paragraph 5
5. The Agency shall draw up scientific guidelines in accordance with Article 138 of [revised Regulation No (EC) 726/2004], to specify technical details regarding the ERA requirements for medicinal products for human use including environmental risk mitigation measures thereof. Where appropriate, the Agency shall consult the European Chemical Agency (ECHA), the European Food Safety Authority (EFSA) and the European Environmental Agency (EEA) on, the European Centre of Disease Control (ECDC) and other relevant stakeholders, including those managing residues from medicinal products and wastewater treatment the drafting of these scientific guidelines.
Amendment 302 #
Proposal for a directive
Article 22 – paragraph 6 – subparagraph 1
Article 22 – paragraph 6 – subparagraph 1
The marketing authorisation holder shall update the ERA with new information without undue delay to the relevant competent authorities, in accordance with Article 90(2), if new information pertaining to the assessment criteria referred to in Article 29 becomes available and could lead to a change of the conclusions of the ERA, including updates on the emissions of the medicinal product in manufacturing effluents. The update shall include any relevant information from environmental monitoring, including monitoring under Directive 2000/60/EC, from eco-toxicity studies, from new or updated risk assessments under other Union legislation, as referred to in paragraph 1, the collation of sales data and environmental exposure data.
Amendment 306 #
Proposal for a directive
Recital 65 a (new)
Recital 65 a (new)
(65 a) Under EU law, originator reference product patent protection status is not a criterion to be considered by authorities when granting a marketing authorisation, approving pricing or granting reimbursement status or any regulatory approval for a generic medicinal product, due to its anitcompetitive effects. In the context of the goals of the revision of the pharmaceutical framework, it is therefore appropriate to explicitly prohibit patent linkage practices in this context.
Amendment 306 #
Proposal for a directive
Article 22 – paragraph 6 – subparagraph 2
Article 22 – paragraph 6 – subparagraph 2
For an ERA conducted prior to [OP please insert the date = 18 months after the date of entering into force of this Directive], the competent authority shall request the marketing authorisation holder to update the ERA if missing information has been identified for medicinal products potentially harmful to the environment and to update missing information in relation to risk mitigation measures referred to in paragraph 3.
Amendment 309 #
Proposal for a directive
Article 22 – paragraph 7
Article 22 – paragraph 7
7. For medicinal products referred to in Articles 9 to 12, the applicant may refer to ERA studies conducted for the reference medicinal product when preparing the ERAand shall provide any other data required in accordance with Annex II and the scientific guidelines referred to in the paragraph 5.
Amendment 312 #
Proposal for a directive
Recital 68 a (new)
Recital 68 a (new)
(68 a) In line with European Green Deal and the European Union Strategic Approach to Pharmaceuticals in the Environment, this regulatory framework should also contribute to avoiding potential risks to the environment. The evaluation of the framework showed that strengthened measures to reduce the environmental impact of medicinal products in the would be necessary.
Amendment 316 #
Proposal for a directive
Article 23 – paragraph 1 – subparagraph 1
Article 23 – paragraph 1 – subparagraph 1
By [OP please insert the date = 3012 months after the date of the entry into force of this Directive] the Agency shall, after consultation with the competent authorities of the Member States, the European Chemical Agency (ECHA), the European Food Safety Authority (EFSA) and the European Environmental Agency (EEA), establish a programme for the ERA to be submitted in accordance with Article 22 of the medicinal products authorised before 30 October 2005 that have not been subject to any ERA and that the Agency has identified as potentially harmful to the environment in accordance with paragraph 2.
Amendment 318 #
Proposal for a directive
Recital 69 a (new)
Recital 69 a (new)
(69 a) There is strong scientific evidence that the emissions of active substances during manufacturing are a threat to the environment and public health. Therefore, the requirements to protect the environment and public health should be extended in order to cover the entire lifecycle of medicinal products, starting from manufacturing, through use and to disposal.
Amendment 320 #
Proposal for a directive
Recital 70
Recital 70
(70) Marketing authorisation applications for medicinal products in the Union should include an Environmental Risk Assessment (ERA) and risk mitigation measures. The proven efficacy and safety of a medicinal product for human use should remain a top criteria in terms of marketing authorisation. However, applicants for marketing authorisation should ensure they complete the ERA in parallel with the marketing authorisation application to be able to sufficiently mitigate negative environmental impacts. The ERA should also evaluate the risks to the environment and public health, including antimicrobial resistance that arise in the manufacturing of medicinal products. If the applicant fails to submit a complete or sufficiently substantiated environmental risk assessment or they do not propose risk mitigation measures to sufficiently address the risks identified in the environmental risk assessment, the marketing authorisation should be refused. The ERA should be updated in a timely manner when new data or knowledge about relevant risks become available. and risk mitigation measures should be adapted accordingly. Moreover, to take into account the additional exposure resulting from the use of the medicinal product, the ERA should be updated in any case five years after the initial authorisation.
Amendment 322 #
Proposal for a directive
Article 23 – paragraph 3
Article 23 – paragraph 3
3. The marketing authorisation holders for medicinal products identified in the programme referred to in paragraph 1 shall submit the ERA to the Agency. The outcome of the assessment of the ERA including the dataa summary of ERA studies and their results as submitted by the marketing authorisation holder and the assessment of the ERA and scientific guidelines referred to in Article 22(5) shall be made publicly available by the Agency.
Amendment 325 #
Proposal for a directive
Article 23 – paragraph 4
Article 23 – paragraph 4
4. Where there are several medicinal products identified in the programme referred to in paragraph 1 that contain the same active substance and that are expected to pose the same risks to the environment, the competent authorities of the Member States or the Agency shall encourageinform and recommend the marketing authorisation holders of the possibility to conduct joint studies for the ERA, to minimise unnecessary duplication of data and use of animals. In this regard, to facilitate and foster the increased use of joint studies, the Agency shall oversee these in a cooridnating role, where necessary and appropriate.
Amendment 329 #
Proposal for a directive
Recital 70 a (new)
Recital 70 a (new)
(70 a) In exceptional cases where the ERA is incomplete due to missing data and this can be duly justified and substantiated by the marketing authorisation holder it should still be able to be placed on the market for reasons in the interest of public health, and with certain post authorisation conditions and oblgiations. Where a medicinal product has been authorised and the ERA is imcomplete for the reason above, the marketing authorisation holder should submit the completed ERA in the timeline agreed with the authorities and deliver upon any other post authorisation obligations.
Amendment 330 #
Proposal for a directive
Recital 70 b (new)
Recital 70 b (new)
(70 b) Detailed requirements for an ERA should be set out in the annexes to this Directive for medicinal products that have been authorised prior to October 2005, i.e. prior to the requirement of submitting an ERA, and specific provisions should be introduced to set up a programme for the environmental risk assessement of those products that are identified as potentially harmful to the environment. Moreover, the establishment of a single Union assessment of the environmental properties of active substances for veterinary use by means of an active substance based review (‘monograph’) system could be potential alternative. Such a system should be set up by the Agency following a positive recommendation of the Commission.
Amendment 331 #
Proposal for a directive
Article 24 – paragraph 4
Article 24 – paragraph 4
4. The Agency in cooperation with the competent authorities of the Member States shall conduct a proof-of-concept pilot of ERA monographs to be completed within threewo years after entering into force of this Directive.
Amendment 333 #
Proposal for a directive
Recital 72
Recital 72
(72) The emissions and discharges of antimicrobials to the environment from manufacturing sites may lead to the proliferation of antimicrobial resistance (“AMR”), which is a global concern regardless of where the emissions and discharges take place. Therefore, the ERA scope should be extended to cover the risk of AMR selection during the entire life cycle of antimicrobials, including manufacturing.
Amendment 348 #
Proposal for a directive
Recital 93
Recital 93
(93) To optimise the use of resources for both applicants for marketing authorisation and competent authorities and avoid duplication of assessment of chemical active substances of medicinal products, marketing authorisation applicants should be able to rely on an active substance master file certificate or a monograph of the European Pharmacopeia, instead of submitting the relevant data as required in accordance with Annex II. An active substance master file certificate may be granted by the Agency when the relevant data on the active substance concerned is not already covered by a monograph of the European Pharmacopeia or by another active substance master file certificate. The Commission should be empowered to establish the procedure for the single assessment of an active substance master file. To further optimise the use of resources, the Commission should be empowered to allow use a certification scheme also for additional quality master files i.e. for active substances other than chemical active substances, or for other substances present or used in the manufacture of a medicinal product, required in accordance with Annex II, e.g. in case of novel excipients, adjuvants, radiopharmaceutical precursors and active substance intermediates, when the intermediate is a chemical active substance by itself or used in conjugation with a biological substance.
Amendment 349 #
Proposal for a directive
Recital 100
Recital 100
(100) It is necessary to take account of changes arising as a result of international harmonisation of definitions, terminology and technological developments in the field of pharmacovigilance and digitalisation.
Amendment 350 #
Proposal for a directive
Article 29 – paragraph 1 – point a
Article 29 – paragraph 1 – point a
(a) shall verify within 20 days whether the particulars and documentations submitted in support of the application comply with Articles 6 and 9 to 14 (‘validation’), and examine whether the conditions for issuing a marketing authorisation set out in Articles 43 to 45 are complied with;
Amendment 351 #
Proposal for a directive
Article 29 – paragraph 3
Article 29 – paragraph 3
3. Where the competent authority of the Member State considers that the marketing authorisation application is incomplete, or contains critical deficiencies that may prevent the evaluation of the medicinal product it shall inform the applicant accordingly and shall set a time limit of minimum 14 days for submitting the missing information and documentation. If the applicant fails to provide the missing information and documentation within the time limit set, the application shall be considered to have been withdrawn by default.
Amendment 352 #
Proposal for a directive
Article 29 – paragraph 4 – subparagraph 2
Article 29 – paragraph 4 – subparagraph 2
The competent authority of the Member State shall summarise the deficiencies in writing. On this basis, the competent authority of the Member State shall inform the applicant accordingly and set a time limit of minimum 14 days to address the deficiencies. The application shall be suspended until the applicant addresses the deficiencies. If the applicant fails to address those deficiencies within the time limit set by the competent authority of the Member State, the application shall be considered as withdrawn by default.
Amendment 353 #
Proposal for a directive
Recital 105
Recital 105
(105) Experience has shown the need to maintain to a certain extent the principle of the use in medicinal products of those colours authorised as food additives. However, it is also appropriate to foresee a specific assessment for the use of the colour in medicines when a food additive is removed from Union list of food additives when it has a functionality beyond colouring. Therefore, in this specific case, EMA should carry out its own assessment for the use of the colour in medicines, taking into account the EFSA opinion and its underlying scientific evidence, as well as any additional scientific evidence and giving particular consideration to the use in medicines. EMA should also be responsible for following any scientific evidence for the colours retained for specific medicine use only. Directive 2009/35/EC should therefore be repealed.
Amendment 353 #
Proposal for a directive
Article 30 – paragraph 1
Article 30 – paragraph 1
Member States shall take all appropriate measures to ensure that the procedure for granting a marketing authorisation for medicinal products is completed within a maximum of 180 days (excluding clock stops) after the submission of a valid application from the date of validation of a marketing authorisation application.
Amendment 354 #
Proposal for a directive
Recital 109
Recital 109
(109) There may be cases where manufacturing or testing steps of medicinal products need to take place in sites close to patients, for example advanced therapy medicinal products with short shelf-life. In such cases, these manufacturing or testing steps may need to be decentralised to multiple sites to reach patients across the Union. When the manufacturing or testing steps are decentralised, they should be carried out under the responsibility of the qualified person of an authorised central site. Additionally, in order to ensure smooth functioning of decentralised sites under this framework with the activities relevant for other Union legal frameworks, competent authorities of Member States supervising the decentralised site should coordinate their acitivities and supervisory tasks with the relevant authorities responsible for the supervision of the manufacturing or testing activities under other Union acts. The decentralised sites should not require a separate manufacturing authorisation from the one granted to the relevant central site but should be registered by the competent authority of the Member State in which the decentralised site is established. In the case of medicinal products containing, consisting or derived from autologous SoHO, the decentralised sites have to be registered as a SoHO entity as defined in and pursuant to [SoHO Regulation] for the activities of donor review and eligibility assessment, donor testing and collection, or just for collection in the case of products manufactured for autologous use.
Amendment 356 #
Proposal for a directive
Article 34 – paragraph 3
Article 34 – paragraph 3
3. The applicant shall inform all the competent authorities of all Member States of its application at the time of submission. The competent authority of a Member State may request for justified public health reasonsshall have the possibility to to enter the procedure and shall inform the applicant and the competent authority of the reference Member State for the decentralised procedure of its request within 30 days from the date of submission of the application. The applicant shall provide the competent authorities of those Member States entering the procedure with the application without undue delay.
Amendment 359 #
Proposal for a directive
Article 34 – paragraph 4 – subparagraph 2
Article 34 – paragraph 4 – subparagraph 2
The competent authority of the reference Member State for the decentralised procedure shall summarise the deficiencies in writing. On this basis, the competent authority of the reference Member State for the decentralised procedure shall inform the applicant and the competent authorities of the Member States concerned accordingly and set a time limit of minimum 14 days to address the deficiencies. The application shall be suspended until the applicant addresses the deficiencies. If the applicant fails to address those deficiencies within the time limit set by the competent authority of the reference Member State for the decentralised procedure, the application shall be considered as withdrawn.
Amendment 360 #
Proposal for a directive
Article 34 – paragraph 5
Article 34 – paragraph 5
5. Within 120 days after validation of the application, the competent authority of the reference Member State for the decentralised procedure shall prepare an assessment report, a summary of product characteristics, the labelling and the package leaflet and shall send them to the Member States concerned and to the applicant. During this period, a competent authority of a Member State may request to recognise and enter the procedure after validation and shall inform the applicant and the competent authority of the reference Member State for the decentralised procedure.
Amendment 361 #
Proposal for a directive
Article 36 – paragraph 4
Article 36 – paragraph 4
4. The applicant shall inform the competent authorities of all Member States of its application at the time of submission. The competent authority of a Member State may request for justified public health reasonsshall have the possibility to enter the procedure and shall inform the applicant and the competent authority of the reference Member State for the mutual recognition procedure of its request within 30 days from the date of submission of the application. The applicant shall provide the competent authorities of those Member States entering the procedure with the application without undue delay.
Amendment 363 #
Proposal for a directive
Article 36 – paragraph 4 a (new)
Article 36 – paragraph 4 a (new)
4 a. In order to examine an application submitted in accordance with Articles 6 and 9 to 14, the competent authorities of the Member States shall verify within 20 days whether the particulars and documentations submitted in support of the application comply with Articles 6 and 9 to 14 (‘validation’), and examine whether the conditions for issuing a marketing authorisation set out in Articles 43 to 45 are complied with;
Amendment 365 #
Proposal for a directive
Recital 129
Recital 129
(129) Where Member States decide thatshould make the package leaflet should be made available in principle onlyavailable electronically, and they should also ensure that a paper version of the package leaflet is to be made available on demand and without additonal cost to patientsprovided.. They should also ensure that the information in digital format is easily accessible to all patients, for instance by including in the outer packaging of the product a digitally readable barcode, which would direct the patient to the electronic version of the package leaflet. However, Member States should be able to choose to use only electronic leaflets for a limited range of medicinal products dispensed to in hospital patients where the provision of medical information can be ensured by a health professional. The Commission should be empowered in the future to, by means of delegated acts, transition completely to electronic leaflets.
Amendment 370 #
Proposal for a directive
Recital 131
Recital 131
(131) To ensure a high level of transparency of public and private support to the research and development of medicinal products, the reporting of public and private contribution for the development of a particular medicinal product should be a requirement for all medicines. Given however the practical difficulty to identify how indirect public funding instruments, such as tax advantages, have supported a particular product, the reporting obligation should only concern the direct public financial support, such as direct grants or contractThis should apply also to any independent legal entity from which it obtained a license in relation to the medicinal product in its previous phases of development. The information should be dissagregated to each stage of drug research and development, basic research, pre-clinical research, phase I, II, III of the clinical investigation of the medicinal product; as well as post-market studies. Therefore, the provisions of this Directive ensure, without prejudice to the rules on the protection of confidential and personal data, transparency regarding any direct and indirect financial support received from any public authority or public body to carry out any activities for the research and development of medicinal products.
Amendment 371 #
Proposal for a directive
Article 43 – paragraph 3
Article 43 – paragraph 3
3. The competent authorities of the Member States shall, without undue delay, make publicly available the national marketing authorisation together with the summary of product characteristics, the package leaflet, the antimicrobial stewardship plan and special information requirements referred to in Article 17 (1), as well as any conditions established in accordance with Articles 44, 45 and any obligations imposed subsequently in accordance with Article 17 (2) and Article 87, together with any deadlines for the fulfilment of those conditions and obligations for each medicinal product that they have authorised.
Amendment 374 #
Proposal for a directive
Recital 133
Recital 133
(133) In order to ensure a harmonised and consistent reporting of public and private contribution for the development of a particular medicinal products, the Commission should be able to adopt implementing acts to clarify the principles and format that the marketing authorisation holder should adhere to when reporting this information.
Amendment 374 #
Proposal for a directive
Article 43 – paragraph 6
Article 43 – paragraph 6
6. The competent authorities of the Member States shall make the assessment report publicly available without undue delay, together with the reasons for their opinion, after deletion of any information of a commercially confidential nature, unless there is an overriding public interest in disclosure. The justification shall be provided separately for each therapeutic indication applied for.
Amendment 375 #
Proposal for a directive
Recital 133 a (new)
Recital 133 a (new)
(133 a)It is imperative to clarify in the legislative framework that all those products that have not been subject to an authorisation process provided for in this Directive or in [revised Regulation] and cannot be considered as a medicinal product, but rather as non-medicinal products, should not be presented to the public with pharmacological properties or unproven therapeutic benefits. The presentation and promotion of non- medicinal products for unauthorised therapeutic indications poses an obvious risk, which can encourage people to abandon science-based therapeutic treatments and put their health at risk. Products classified as non-medicinal must be explicitly prohibited from using these types of false claims linked to improving health. Likewise, citizens should be given the education and tools to reject and report such unsubstantiated health claims.
Amendment 375 #
Proposal for a directive
Article 44 – paragraph 1 – subparagraph 1 – point g
Article 44 – paragraph 1 – subparagraph 1 – point g
(g) in case of medicinal products for which, on duly justified grounds described in the assessment report, there is substantial uncertainty as to the surrogate endpoint relation to the expected health outcome, where appropriate and relevant for the benefit-risk balance, with particular attention to new active substances and therapeutic indications, a post- authorisation obligation to substantiate the clinical benefit;
Amendment 377 #
Proposal for a directive
Recital 135
Recital 135
(135) Advertising, even of medicinal products not subject to a prescription, could affect public health and distort competition. Therefore, advertising of medicinal products should meet certain criteria ensuring high standards of protection. Persons qualified to prescribe, administer or supply medicinal products can properly evaluate the information available in advertising because of their knowledge, training and experience. The advertising of medicinal products to persons who cannot properly assess the risk associated with their use may lead to medicinal product misuse or overconsumption which is liable to harm public health. Therefore advertisement to the general public of medicinal products that are available only on medical prescription should be prohibited. Furthermore, distribution of samples free of charge to the general public for promotional ends is to be prohibited, also teleshopping for medicinal products shall be prohibited pursuant to Directive 2010/13/EU of the European Parliament and of the Council65 [1]. It should be possible within certain restrictive conditions to provide samples of medicinal products free of charge to persons qualified to prescribe or supply them so that they can familiarise themselves with new products and acquire experience in dealing with them. _________________ 65 Directive 2010/13/EU of the European Parliament and of the Council of 10 March 2010 on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the provision of audiovisual media services (Audiovisual Media Services Directive) (OJ L 095 15.4.2010, p. 1).
Amendment 379 #
Proposal for a directive
Article 47 – paragraph 1 – point d
Article 47 – paragraph 1 – point d
(d) the environmental risk assessment is incomplete or insufficiently substantiated or the reason for the imcomplete nature of the ERA are not duly justified or subtantiated by the applicant or if the risks identified in the environmental risk assessment have not been sufficiently addressed by the applicant or by the risk mitigation measures by the applicant, in accordance Article 22 (3) this Directive;
Amendment 381 #
Proposal for a directive
Recital 145
Recital 145
(145) In order to ensure uniform conditions for the implementation of this RegulationDirective, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council66 . _________________ 66 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13)[1].
Amendment 386 #
Proposal for a directive
Article 51 – paragraph 1 – point f
Article 51 – paragraph 1 – point f
(f) contains an active substance whichor any of its ingredients or constituent parts are persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative, or persistent, mobile and toxic, or very persistent and very mobile or listed in Annex X of Directive 2000/60/EC or Annex I of Directive 2006/118/EC for which medical prescription is required as risk minimisation measure with regard to the environment, unless the use of the medicinal product and the patient safety require otherwise.
Amendment 387 #
Proposal for a directive
Article 51 – paragraph 2
Article 51 – paragraph 2
2. Member States may set additional conditions on the prescription of antimicrobials, restrict the validity of medical prescription and limit the quantities prescribed to the amount required for the treatment or therapy concerned or submitting certain antimicrobial medicinal products to special medical prescription or restricted prescription.
Amendment 388 #
Proposal for a directive
Article 1 – paragraph 4
Article 1 – paragraph 4
4. In cases where, taking into account all its characteristics, questions arise as to the regulatory status of product or a product falls within the definition of a ‘medicinal product’ and within the definition of a product covered by other Union law and there is a conflict between this Directive and other Union law, the provisions of this Directive shall prevail. egislation, the Agency and the advisory and regulatory bodies established in other Union legislation shall consult as relevant, in order to find consensus on the regulatory status of the product or the application of Union law to the product.
Amendment 388 #
Proposal for a directive
Article 51 – paragraph 2 a (new)
Article 51 – paragraph 2 a (new)
2 a. Member States shall, wherever possible, provide for per unit prescription and dispensing for the treatment or therapy concerned.
Amendment 389 #
Proposal for a directive
Article 1 – paragraph 4 – subparagraph 1 (new)
Article 1 – paragraph 4 – subparagraph 1 (new)
Where the Agency and the advisory and regulatory bodies established in other Union legislation cannot reach consensus on the regulatory status or Union law applicable to the product:
Amendment 390 #
Proposal for a directive
Article 1 – paragraph 4 – point a (new)
Article 1 – paragraph 4 – point a (new)
(a) the Commission shall be empowered to take a decision on the regulatory status or the Union law applicable to the law in question, duly taking into account the relevant opinions and conclusions of the Agency and other advisory bodies and regulatory bodies established under Union law. This decision along with the supporting analysis and conclusion shall be made publicly available;
Amendment 391 #
Proposal for a directive
Article 1 – paragraph 4 – point b (new)
Article 1 – paragraph 4 – point b (new)
(b) for transparency purposes, the respective opinions and conclusions of the Agency and the relevant advisory and regulatory bodies should be made publicly available.
Amendment 393 #
Proposal for a directive
Article 56 – paragraph 3 – subparagraph 1 a (new)
Article 56 – paragraph 3 – subparagraph 1 a (new)
For SoHO-derived medicinal products, which are obtained from altruistic and unpaid donations, Member States shall ensure, through public service obligations, that manufacturers, within the limits of their responsibilities, provide an appropriate and continuous supply to patients in each Member State. Member States shall negociate fair and transparent prices for SoHO-derived medicinal products and ensure that low-profit products are also available to patients and that there is a continuous investment on research and innovation for those products. When medicinal products are derived from donated SoHOs, manufacturers must, as for public service obligation in the Member States, report annually to the authorities the amount of processed locally-collected SoHOs and medicinal products prepared from them.
Amendment 394 #
Proposal for a directive
Article 56 – paragraph 4
Article 56 – paragraph 4
4. The marketing authorisation holder shall, at all stages of manufacturing and distribution, within the limits of its responsability, ensure that the starting materials and ingredients of the medicinal products and the medicinal products themselves comply with the requirements of this Directive and, where relevant, the [revised Regulation (EC) No 726/2004] and other Union law and shall verify that such requirements are met.
Amendment 395 #
Proposal for a directive
Article 56 – paragraph 7
Article 56 – paragraph 7
7. Where the marketing authorisation holder considers or has reason to believe that the medicinal product it has made available on the market is not in conformity with the marketing authorisation or this Directive and the [revised Regulation (EC) No 726/2004] it shall immediately take the necessary corrective actions to bring that medicinal product into conformity, to withdraw it or recall it, as appropriate, in consultation with the competent authorities. The marketing authorisation holder shall immediately inform the competent authorities and the distributors concerned to that effect.
Amendment 397 #
Proposal for a directive
Article 1 – paragraph 6
Article 1 – paragraph 6
Amendment 398 #
Proposal for a directive
Article 57 – title
Article 57 – title
Responsibility to report on public financial support and cost data for all applicable research and development activities of medicinal products
Amendment 399 #
Proposal for a directive
Article 57 – paragraph 1
Article 57 – paragraph 1
1. The marketing authorisation holder shall declare to the public any direct and indirect financial support received from any public authority or publicly funded bodyforeign or european private entity, including philantropic entities, public authority or publicly funded body, including tax advantages and subsidies, in relation to any activities for the research and development of the medicinal product covered by a national or a centralised marketing authorisation, irrespective of the legal entity that received that support.
Amendment 404 #
Proposal for a directive
Article 1 – paragraph 7
Article 1 – paragraph 7
7. Member States shall take the necessary measures to achieve autonomy of supply of substances of human origin, to develop the production and use of SoHO therapies and medicinal products derived from substances of human origin coming from voluntary unpaid donations, under the provisions on [Regulation (EC) repealing Directives 2002/98/EC and 2004/23/EC].
Amendment 405 #
Proposal for a directive
Article 57 – paragraph 1 a (new)
Article 57 – paragraph 1 a (new)
1 a. The marketing authorisation holder shall also report an estimate of the costs incurred for the research and development of the medicinal product covered by a national or a centralised marketing authorization.
Amendment 406 #
Proposal for a directive
Article 1 – paragraph 10
Article 1 – paragraph 10
Amendment 409 #
Proposal for a directive
Article 57 – paragraph 2 – point a – point ii
Article 57 – paragraph 2 – point a – point ii
(ii) the public authority or publicly funded bodentity that provided the financial support referred to in point (i);
Amendment 411 #
Proposal for a directive
Article 57 – paragraph 2 – point a – point iii a (new)
Article 57 – paragraph 2 – point a – point iii a (new)
(iii a) any independent legal entity from which it obtained a license in relation to, or acquired, the medicinal product in its previous phases of development, and at which stage of the research and development process. The marketing authorisation holder shall, as much as possible, include in the report information on any public or private funding received by the independent entity for its research activities in relation to the medicinal product.
Amendment 413 #
Proposal for a directive
Article 57 – paragraph 2 – point a – point iii b (new)
Article 57 – paragraph 2 – point a – point iii b (new)
(iii b) an estimate of the total costs incurred for the research and development of the medicinal product, which shall be disaggregated to each stage of drug research and development, including basic research, pre-clinical research, phase I, II, III of the clinical investigation of the medicinal product; as well as post-market studies.
Amendment 421 #
Proposal for a directive
Article 2 – paragraph 1
Article 2 – paragraph 1
1. By way of derogation from Article 1(1), only this Article shall apply to advanced therapy medicinal products prepared on a non-routine basis in accordance with the requirements set in paragraph 3 and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient (‘advanced therapy medicinal products prepared under hospital exemption’).
Amendment 421 #
Proposal for a directive
Article 58 – paragraph 4
Article 58 – paragraph 4
4. The marketing authorisation holder and it´s suppliers shall have in place systems and procedures to identify the other natural or legal persons to whom products referred to in paragraph 2 have been supplied. This information shall, upon request, be made available to the competent authorities.
Amendment 433 #
3. Member States shall ensure that advanced therapy medicinal products prepared under hospital exemption comply with the requirements equivalent to the good manufacturing practices and traceability for advanced therapy medicinal products referred to in Articles 5 and 15 of Regulation (EC) No 1394/200769 [1] respectively, and with pharmacovigilance requirements equivalent to those provided for at Union level pursuant to [revised Regulation (EC) No 726/2004]. _________________ 69 Regulation (EC) No 1394/2007 of the European ParliamentThis shall include site inspections and GMP CPF accreditation, as well as traceability and pharmacovigilance plans and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 1)evaluation of the preclinical and clinical data generated by the applicant.
Amendment 433 #
Proposal for a directive
Article 63 – paragraph 3
Article 63 – paragraph 3
3. Member States may decidshall ensure that the package leaflet ishall be made available in paper format orand electronically, or both. In the absence of such specific rules in a Member State, a package leaflet in paper format shall be included in the packagi. Member States may choose to use only electronic leaflets for a limited range of a medicinal product. If the package leaflet is only made available electronically, thees dispensed to in-hospital patient’s right to a printed copy of the package leaflet should be guaranteed upon request and free of charge and it should be ensured that the information in digital format is easily accessible to all patientwhere the provision of medical information will be ensured by health professionals.
Amendment 437 #
Proposal for a directive
Article 2 – paragraph 4
Article 2 – paragraph 4
4. Member States shall ensure that data on the use, safety and the efficacy of advanced therapy medicinal products prepared under hospital exemption is collected and reported by the hospital exemption approval holder to the competent authority of the Member State at least annually. The competent authority of the Member State shall review such data and shall verify the compliance of advanced therapy medicinal products prepared under hospital exemption with the requirements referred to in paragraph 3set the requirements for the collection and reporting of such data, in a structured and standarized way that allows obtaining more robust, reliable and comparable results and conclusions. The competent authority of the Member State shall review such data and shall verify the compliance of advanced therapy medicinal products prepared under hospital exemption with the requirements referred to in paragraph 3. Competent authorities shall ensure that sufficient scientific and regulatory advice is provided to non-profit and academic institutions in order to ensure appropriate reporting mechanisms.
Amendment 444 #
Proposal for a directive
Article 2 – paragraph 4 a (new)
Article 2 – paragraph 4 a (new)
4 a. Competent authorities shall ensure that sufficient scientific and regulatory advice is provided to non-profit and academic institutions in order to assist them through the requirements of the hospital exemption clause. In cases where a product under hospital exemption becomes a suitable candidate to begin a centralized marketing authorization procedure, competent authorities shall assist non-profit and academic institutions also through this authorization process.
Amendment 451 #
Proposal for a directive
Article 2 – paragraph 6
Article 2 – paragraph 6
6. The competent authority of the Member State shall transmit the data related to the use, safety and efficacy of an advanced therapy medicinal product prepared under the hospital exemption approval to the Agency annually. The Agency shall, in collaboration with the competent authorities of Member States and the Commission, set up and maintain a repository of that data, as well as of information on the authorisation, suspension or withdrawal of hospital exemption approvals, reimbursement prices, and public and private contributions to the development of the product; which shall be updated regularly.
Amendment 452 #
Proposal for a directive
Article 63 – paragraph 5
Article 63 – paragraph 5
5. The Commission is empowered to adopt delegated acts in accordance with Article 215 to amend paragraph 3 by making mandatory the electronic version of the packagin order to progressively reduce the use of the paper format of the leaflet. That delegated act shall also establish the patient’s right to a printed copy of the package leaflet upon request and free of charge. The delegation of powers shall apply as of [OP please insert the date = five years following 18 months after the date of entering into force of this Directive].
Amendment 453 #
Proposal for a directive
Article 63 – paragraph 6
Article 63 – paragraph 6
6. The Commission shall adopt implementing acts in accordance with the examination procedure referred to in Article 214(2) to establish common standards for the electronic version of the package leaflet, the summary of product characteristics and the labelling, taking into account available technologies. Member States shall implement this article after the publication of the Commissions implementing acts on the common standards for electronic versions of the package leaflet.
Amendment 465 #
Proposal for a directive
Article 63 – paragraph 7
Article 63 – paragraph 7
7. Where the package leaflet is made available electronically, the individual right to privacy shall be ensured. Any technology giving access to the information shall ensure the protection of personal data in line with Regulation (EU) 2016/679 and Directive 2002/58/EC and not allow the identification, profiling or tracking of individuals, nor shall it be used for commercial purposes, including advertising and marketing activities.
Amendment 467 #
Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 – point d
Article 2 – paragraph 7 – subparagraph 1 – point d
(d) the modalities for preparation and use of advanced therapy medicinal products under hospital exemption on a non-routine basis.;
Amendment 468 #
Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 – point d a (new)
Article 2 – paragraph 7 – subparagraph 1 – point d a (new)
(d a) the modalities of guidance for academic and other not-for-profit entities through the requirements of the hospital exemption clause and the centralised marketing authorisation procedure.
Amendment 472 #
Proposal for a directive
Article 64 – paragraph 3
Article 64 – paragraph 3
3. The package leaflet shall reflectIn addition to the measures specified in paragraph 2, for medicinal products included in the list referred to in Article 112a of the [results of consultations with target patient groups to ensure that it is legible, clear and easy to usevised Regulation (EC) No 726/2004], the following additional statement shall be included ‘This medicinal product is subject to additional monitoring’. This statement shall be preceded by the symbol referred to in the aforementioned Article and followed by a standardised explanatory sentence that is appropriate, clearly legible, and easy to understand by users.
Amendment 474 #
Proposal for a directive
Article 2 – paragraph 8 a (new)
Article 2 – paragraph 8 a (new)
8 a. Competent authorities shall guarantee that the authorization of products through the centralized procedure shall not adversely affect the activities and responsibilities of developers functioning under the hospital exemption as outlined in paragraphs 3 and 4.
Amendment 477 #
Proposal for a directive
Article 3 – paragraph 1 – subparagraph 1
Article 3 – paragraph 1 – subparagraph 1
A Member State may, in order to fulfil special needs, exclude from the scope of this Directive medicinal products supplied in response to a bona fide unsolicited order, prepared in accordance with the specifications of an authorised healthcare professional and for use by an individual patient under their direct personal responsibility, or prepared in accordance with the specifications of a competent authority. However, in such case Member States shall encourage healthcare professionals and patients to report data on the safety of the use of such products to the competent authority of the Member State in accordance with Article 97.
Amendment 483 #
Proposal for a directive
Article 4 – paragraph 1 – point 1 – introductory part
Article 4 – paragraph 1 – point 1 – introductory part
(1) ‘medicinal product’ means any known substance or combination of substances that fulfils at least one of the following conditions:
Amendment 484 #
Proposal for a directive
Article 4 – paragraph 1 – point 1 – point a
Article 4 – paragraph 1 – point 1 – point a
(a) any substance or combination of substances that is presented as having propertiespresents pharmacological activity that can be used for treating or preventing disease in human beings; or
Amendment 485 #
Proposal for a directive
Article 4 – paragraph 1 – point 1 – point b
Article 4 – paragraph 1 – point 1 – point b
(b) any substance or combination of substances that may be used in or administered to human beings with a view to either restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis;.
Amendment 485 #
Proposal for a directive
Article 69 – paragraph 1
Article 69 – paragraph 1
1. The marketing authorisation holder shall ensure availability of educational material to healthcare professionals, including through medical sales representatives as referred to in Article 175(1), point (c), regarding the appropriate use of diagnostic tools, testing or other diagnostic approaches related to antimicrobial- resistant pathogens, that may inform on the use of the antimicrobial. As referred to in paragraph 1 (b) of Article 17, the competent authority responsible for approving the antimicrobial shall review the content of the educational material and validate the final version.
Amendment 487 #
Proposal for a directive
Article 4 – paragraph 1 – point 10 a (new)
Article 4 – paragraph 1 – point 10 a (new)
(10 a) 'clock stop’ means a period of time during which the evaluation of a medicine is officially stopped, while the applicant prepares responses to questions from the regulatory authority. The clock resumes when the applicant has sent its responses.
Amendment 487 #
Proposal for a directive
Article 69 – paragraph 2 – subparagraph 2
Article 69 – paragraph 2 – subparagraph 2
Member States may decidshall ensure that the awareness card ishall be made available in both in paper format orand electronically, or both. In the absence of such specific rules in a Member State, an awareness card in paper format shall be included in the packaging of an antimicrobial.
Amendment 488 #
Proposal for a directive
Article 69 – paragraph 3
Article 69 – paragraph 3
3. The text of the awareness card shall be standarded by the Agency and shall be aligned with Annex VI.
Amendment 490 #
Proposal for a directive
Article 4 – paragraph 1 – point 12
Article 4 – paragraph 1 – point 12
(12) ‘reference medicinal product’ means a medicinal product that is or has been authorised in the Union under Article 5, in accordance with Article 6, that can be used for comparative purposes againts another medicinal product of similar characteristics;
Amendment 491 #
Proposal for a directive
Article 4 – paragraph 1 – point 13
Article 4 – paragraph 1 – point 13
(13) ‘generic medicinal product’ means a medicinal product that has the same qualitative and quantitative composition in active substances and ,the same pharmaceutical form and pharmaceutical equivalence as the reference medicinal product;
Amendment 491 #
Proposal for a directive
Article 74 – paragraph 4
Article 74 – paragraph 4
4. TBased on any of the grounds listed in Article 75, the competent authorities of the Member State may also grant a full or partial exemption to the obligation that the labelling and the package leaflet must be in an official language or official languages of the Member State where thea medicinal product is placed on the market, as specified, for the purposes of this Directive, by that Member State. For the purpose of multi-language packages, Member States may allow the use on the labelling and package leaflet of an official language of the Union that is commonly understood in the Member States where the multi-language package is marketedWhen a competent authority grants an exemption to the language requirements that apply to the paper package leaflet, the patients’ right to a printed copy of the document in the official language or official languages of the Member State should be guaranteed upon request and free of charge.
Amendment 493 #
Proposal for a directive
Article 4 – paragraph 1 – point 16
Article 4 – paragraph 1 – point 16
(16) ‘fixed dose combination medicinal product’ means a medicinal product consisting of a combination of active substances, at a fixed dose, intended to be placed on the market as a single pharmaceutical form;
Amendment 494 #
Proposal for a directive
Article 4 – paragraph 1 – point 20
Article 4 – paragraph 1 – point 20
(20) ‘kit for radiopharmaceutical preparations’ means any preparation to be reconstituted or combined with radionuclides in the final radiopharmaceutical, usually prior to its administration;
Amendment 496 #
Proposal for a directive
Article 80 – title
Article 80 – title
Regulatory data and, market protection and market exclusivity
Amendment 497 #
Proposal for a directive
Article 80 – paragraph 2 a (new)
Article 80 – paragraph 2 a (new)
2 a. The period referred to in parragraph 2 shall be extended by an addittional period of one year, where the marketing authorization holder obtains, during the data protection period referred to in Article 81, an authorisation for an additional therapeutic indication for which the marketing authorisation holder has demonstrated, with supporting data, a significant clinical benefit in comparison with existing therapies. This extension may only be granted once.
Amendment 498 #
Proposal for a directive
Article 80 – paragraph 4
Article 80 – paragraph 4
4. By way of derogation from the paragraphs 1 and 2, when a compulsory licence has been granted by a relevant authority in the Union to a party to address asafeguard public health emergency, the data and market protection as well as the market exclusivity referred to in Article 71 of [revised Regulation (EC) No 726/2004], shall be suspended with regard to that party insofar as the compulsory licence requires, and during the duration period of the compulsory licence. Relevant authorities in the Union shall also be able to reduce the duration of data protection, market protection, or market exclusivity for medicinal products that are not protected by a patent or a supplementary protection certificate, where necessary to safeguard public health.
Amendment 499 #
Proposal for a directive
Article 4 – paragraph 1 – point 22
Article 4 – paragraph 1 – point 22
(22) ‘antimicrobial’ means any medicinal product with a direct action on micro-organisms (including viruses) used for treatment or prevention of infections or infectious diseases, including antibiotics, antivirals and antifungals;
Amendment 501 #
Proposal for a directive
Article 4 – paragraph 1 – point 28
Article 4 – paragraph 1 – point 28
(28) 'vaccine’ means any medicinal product that is intended to elicit an immune response against an antigen or antigens for prevention, including post exposure prophylaxis, and for treatment of diseases caused by an infectious agent;
Amendment 504 #
Proposal for a directive
Article 4 – paragraph 1 – point 29 – point a
Article 4 – paragraph 1 – point 29 – point a
(a) a substance or a combination of substances intended to edit the host genome in a sequence-specific manner or that contains or consists of cells subjected to such genetic modifications; or
Amendment 507 #
Proposal for a directive
Article 81 – paragraph 1
Article 81 – paragraph 1
1. The regulatory data protection period shall be sixfour years from the date when the marketing authorisation for that medicinal product was granted in accordance with Article 6(2). For marketing authorisations that belong to the same global marketing authorisation the period of data protection shall start from the date when the initial marketing authorisation was granted in the Union.
Amendment 510 #
Proposal for a directive
Article 4 – paragraph 1 – point 30 – paragraph 1 – point b
Article 4 – paragraph 1 – point 30 – paragraph 1 – point b
(b) is presented as havings properties for, or is used in or administered to human beings with a view to treating, preventing or diagnosing a disease through the pharmacological, immunological or metabolic action of its cells or tissues.
Amendment 516 #
Proposal for a directive
Article 4 – paragraph 1 – point 31 – point a
Article 4 – paragraph 1 – point 31 – point a
(a) a method involving an industrial process which includes pooling of donations, for purposes beyond processing of SoHOs for concentrates or pathogen inactivation; or
Amendment 521 #
Proposal for a directive
Article 4 – paragraph 1 – point 33
Article 4 – paragraph 1 – point 33
(33) ‘environmental risk assessment’ means the evaluation of the risks and potential risks to the environment, or risks to public health, posed by the release of the medicinal product in the environment from the use, manufacturing and disposal of the medicinal product and the identification of risk prevention, limitation and mitigation measures. For medicinal product with an antimicrobial mode of action, the ERA also encompasses an evaluation of the risk for antimicrobial resistance selection in the environment due to the manufacturing, use and disposal of that medicinal product;
Amendment 521 #
Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point a a (new)
Article 81 – paragraph 2 – subparagraph 1 – point a a (new)
(a a) 12 months, where the marketing authorisation holder demonstrates that the preclinical development of the medicinal product has been done within the Union as referred to in Article 82a;
Amendment 526 #
Proposal for a directive
Article 4 – paragraph 1 – point 34
Article 4 – paragraph 1 – point 34
(34) ‘antimicrobial resistance’ means the ability of a micro-organism to survive or to grow in the presence of a concentration of an antimicrobial agent that is usually or was in the past sufficient to inhibit or kill that micro- organism;
Amendment 531 #
Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point d
Article 81 – paragraph 2 – subparagraph 1 – point d
Amendment 535 #
Proposal for a directive
Article 4 – paragraph 1 – point 59
Article 4 – paragraph 1 – point 59
(59) ‘adverse reaction’ means an effect on a person in response to a received medicinal product that is noxious and unintended;
Amendment 536 #
Proposal for a directive
Article 4 – paragraph 1 – point 60
Article 4 – paragraph 1 – point 60
(60) ‘serious adverse reaction’ means an adverse reaction that results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, produces a notable reduction of patient’s quality of life or is a congenital anomaly or a birth defect;
Amendment 538 #
Proposal for a directive
Article 4 – paragraph 1 – point 62
Article 4 – paragraph 1 – point 62
Amendment 539 #
Proposal for a directive
Article 4 – paragraph 1 – point 64
Article 4 – paragraph 1 – point 64
(64) ‘herbal medicinal product’ means any medicinal product, exclusively containing as source of active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more herbal preparations;
Amendment 541 #
Proposal for a directive
Article 81 – paragraph 2 – subparagraph 3
Article 81 – paragraph 2 – subparagraph 3
Amendment 542 #
Proposal for a directive
Article 4 – paragraph 1 – point 70
Article 4 – paragraph 1 – point 70
(70) ‘public service obligation’ means to guaranteensure permanently an adequate range of medicinal products to meet the requirements of a specific geographical area and to deliver the supplies requested within a very short time over the whole of the area in question.
Amendment 544 #
Proposal for a directive
Article 4 – paragraph 1 – point 70 a (new)
Article 4 – paragraph 1 – point 70 a (new)
(70 a) "decentralised manufacturing" means a production model where manufacturing of medicinal products needs to take place in local sites close to patients.
Amendment 545 #
Proposal for a directive
Article 4 – paragraph 2
Article 4 – paragraph 2
Amendment 548 #
Proposal for a directive
Article 5 – paragraph 2
Article 5 – paragraph 2
2. When an initial marketing authorisation has been granted in accordance with paragraph 1, any development concerning the medicinal product covered by the authorisation such as additional therapeutic indication, strengths, pharmaceutical forms, administration routes, presentations, as well as any variations of the marketing authorisation shall also be granted an authorisation in accordance with paragraph 1 or be included in the initial marketing authorisation. All those marketing authorisations as well as those obtained by this marketing authorisation holder according to Articles 9 to 12 shall be considered as belonging to the same global marketing authorisation, in particular for the purpose of the marketing authorisations applications under Articles 9 to 12, including as regards the expiry of the regulatory data protection period for applications using a reference medicinal product.
Amendment 552 #
Proposal for a directive
Article 82 – paragraph 1 – subparagraph 2
Article 82 – paragraph 1 – subparagraph 2
The prolongation referred to in the first subparagraph shall apply to medicinal products that have been granted a centralised marketing authorisation, as referred to in Article 5 or that have been granted a national marketing authorisation through the decentralised procedure, as referred to in Chapter III, Section 3covering all the Member States entered into the decentralised procedure, as referred to in Chapter III, Section 3. The prolongation of the data protection period in regards medicinal products which obtained marketing authorisation in accordance with Articles 5 and 6 of [revised Regulation (EC) No 726/2004] as referred to in Article 81(2), first subparagraph, point (a), shall apply to medicinal products if they are released and continuously supplied into the supply chain in a sufficient quantity and in the presentations necessary to cover the needs of the patients in the Member States concerned in which the marketing authorisation is valid.
Amendment 555 #
Proposal for a directive
Article 82 – paragraph 2 – subparagraph 3 a (new)
Article 82 – paragraph 2 – subparagraph 3 a (new)
Where the conditions set out in paragraph 1 have not been fully satisified due to duly justified circumstances out of the control of the marketing authoristisation holder the Member State shall confirm the conditions in paragraph 1 have been satisified in their territory, subject to guarantee that these conditions will be fulfilled in an acceptable period of time agreed between the marketing authorisation holder and the Member State.
Amendment 556 #
Proposal for a directive
Article 82 – paragraph 2 – subparagraph 4
Article 82 – paragraph 2 – subparagraph 4
Positive decisions adopted in accordance with Articles 2 and 6 of Council Directive 89/105/EEC74[1] shall be considered equivalent to a confirmation referred to in the third subparagraph, point (a). _________________ 74 Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusi, as long as the medicinal product is effectively con tin the scope of national health insurance systems (OJ L 40, 11.2.1989, p. 8)uously supplied on the market.
Amendment 557 #
Proposal for a directive
Article 6 – paragraph 5 – subparagraph 1 – point a a (new)
Article 6 – paragraph 5 – subparagraph 1 – point a a (new)
(a a) in the absence of comparative studies, a justification to substantiate the reasons why the above mentioned studies could not be conducted;
Amendment 559 #
Proposal for a directive
Article 6 – paragraph 7 – subparagraph 2
Article 6 – paragraph 7 – subparagraph 2
The marketing authorisation applicant shall not carry out animal testing in case scientifically satisfactory non-animal testing methods are available. The marketing authorisation applicant shall not carry out animal tests in case scientifically satisfactory non-animal testing methods are available. Where scientifically satisfactory non-animal testing methods are not available, applicants that use animal testing shall ensure that the principle of replacement, reduction and refinement of animal testing for scientific purposes has been applied in compliance with Directive 2010/63/EU with regard to any animal study conducted for the purpose of supporting the application.
Amendment 563 #
Proposal for a directive
Article 9 – paragraph 3 – subparagraph 1
Article 9 – paragraph 3 – subparagraph 1
Paragraph 1 shall also apply if the reference medicinal product has not been authorised in the Member State in which the application for the generic medicinal product is submitted. In this, unless the applicant of the generic product is also the marketing authorisation holder or a related company of the reference medicinal product. In the latter case the complete dossier should be submitted. In the former case, the applicant shall indicate in the application the name of the Member State in which the reference medicinal product is or has been authorised. At the request of the competent authority of the Member State in which the application is submitted, the competent authority of the other Member State shall transmit within a period of one month a confirmation that the reference medicinal product is or has been authorised together with the full composition of the reference medicinal product and if necessary, any other relevant documentation.
Amendment 563 #
Proposal for a directive
Article 82 – paragraph 5
Article 82 – paragraph 5
5. The Commission shall check the application referred to in paragraph 2, subparagraph 2, and grant approval or rejection to the prolongation referred to in Article 81(2). In those cases in which one or more Member States have issued a reasoned statement for refusal of the prolongation, the Commission shall ensure that the reasons described are justified and substantiated. The Commission shall ensure that Marketing Authorisation Holders are not unduly prevented from receiving the incentives for actions beyond their control. Member States representatives may request the Commission to discuss issues related to the practical application of this Article in the Committee established by Council Decision 75/320/EEC75 (‘Pharmaceutical Committee’). The Commission may invite bodies responsible for health technology assessment as referred to in Regulation (EU) 2021/2282 or national bodies responsible for pricing and reimbursement, as required, to participate in the deliberations of the Pharmaceutical Committee. _________________ 75 Council Decision of 20 May 1975 setting up a pharmaceutical committee (OJ L 147, 9.6.1975, p. 23).
Amendment 564 #
Proposal for a directive
Article 82 – paragraph 5 a (new)
Article 82 – paragraph 5 a (new)
5 a. The Commission shall make publicly available any information related to the decision taken on the grant or refusal of the prolongation of the data exclusivity period
Amendment 565 #
Proposal for a directive
Article 10 – paragraph 1
Article 10 – paragraph 1
In cases where the medicinal product does not fall within the definition of a generic medicinal product or has changes in strength, pharmaceutical form, route of administration or therapeutic indications, compared to the reference medicinal product, the results of the appropriate non- clinical tests orand clinical studies shall be provided to the competent authorities to the extent necessary to establish a scientific bridge to the data relied upon ino the extent necessary to demonstrate essential similarity to the marketing authorisation for the reference medicinal product, and to demonstrate the safety and efficacy profile of the hybrid medicinal product in any additional indication.
Amendment 565 #
Proposal for a directive
Article 82 – paragraph 5 b (new)
Article 82 – paragraph 5 b (new)
5 b. Following the extension of the regulatory data protection as referred to in Article 81(2), the medicinal products should be released and continuously supplied into the supply chain in a sufficient quantity and in the presentations necessary to cover the needs of the patients in the Member States in which the marketing authorisation is valid, for the entire duration of the protection time. Where the marketing authorisation holder fails to comply with this obligation, penalties should be established including the revocation of the extended regulatory protection period.
Amendment 568 #
Proposal for a directive
Article 82 – paragraph 6
Article 82 – paragraph 6
6. The Commission, based on the experience of Member States and relevant stakeholders, may adopt implementingdelegated measures relating to the procedural aspects outlined in this Article and regarding the conditions mentioned in paragraph 1. Those implementingdelegated acts shall be adopted in accordance with the procedure referred to in Article 214(2)5.
Amendment 571 #
Proposal for a directive
Article 82 a (new)
Article 82 a (new)
Article82a Prolongation of the data protection period for medicinal products developed within the Union 1. A regulatory data protection period of one year shall be granted for a medicinal product if the marketing authorisation holder can demonstrate that its preclinical development was perfomed in the Union, even if another independent legal entity performed those studies, in initial stages of development, before the marketing authorisation holder acquired it. 2. One year after the date of entering into force of this Directive [OP please insert the date =12 months after the date of entering into force of this Directive], the Commission shall publish a study on the most adecuate indicators to evaluate that the provision in paragraph 1 is met. When performing the study, the Commission shall prioritize those indicators that could bring better outcomes for the promotion of research and development within the Union, specially that performed in SMEs. 3. The Commission shall adopt delegated measures relating to the procedural aspects outlined in this Article and regarding the conditions mentioned in paragraph 1. Those delegated acts shall be adopted in accordance with the procedure referred to in Article 215. When setting up the conditions mentioned in paragraph 1, the Commission shall take into account the conclusions drawn from the study mentioned in paragraph 2.
Amendment 573 #
Proposal for a directive
Article 13 – paragraph 1
Article 13 – paragraph 1
In cases where no reference medicinal product is or has been authorised for the active substance of the medicinal product concerned, the applicant shall, by way of derogation from Article 6(2), not be required to provide the results of non- clinical tests or clinical studies if the applicant can demonstrate that the active substances of the medicinal product have been in well-established medicinal use within the Union for the same therapeutic use and route of administration and for at least ten years, with recognised efficacy and an acceptable level of safety in terms of the conditions set out in Annex II. In that event, the test and trial results shall be replaced by appropriate bibliographic data in the form of scientific literature and demonstration that this literature is relevant for the applied product.
Amendment 579 #
Proposal for a directive
Article 16 – paragraph 1
Article 16 – paragraph 1
1. A marketing authorisation shall be required for radionuclide generators, kits for radiopharmaceutical preparations, and radionuclide precursors, unless they are used as starting material, active substance or intermediate of radiopharmaceuticals covered by a marketing authorisation under Article 5(1).
Amendment 581 #
Proposal for a directive
Article 16 – paragraph 2
Article 16 – paragraph 2
2. A marketing authorisation shall not be required for a radiopharmaceutical prepared at the time of use by a person or by an establishment authorised, according to national legislation, to use such radiopharmaceutical in an approved healthcare establishment exclusively from authorised radionuclide generators, kits for radiopharmaceutical preparations or radionuclide precursors in accordance with the manufacturer's instructions.
Amendment 584 #
Proposal for a directive
Article 17 – paragraph 1 – point b
Article 17 – paragraph 1 – point b
(b) a description of the special information requirements outlined in Article 69 and listed in Annex I, for prior review and approval by the competent authority.
Amendment 590 #
Proposal for a directive
Article 17 – paragraph 2
Article 17 – paragraph 2
2. The competent authority mayshall impose obligations on the marketing authorisation holder if it finds the risk mitigation measures contained in the antimicrobial stewardship plan unsatisfactory.
Amendment 602 #
Proposal for a directive
Article 83 – paragraph 3
Article 83 – paragraph 3
3. Where the Agency adopts scientific guidelines for the application of this Article it shall consult the Commission and the authorities or bodies referred to in Article 162 of [revised Regulation (EC) No 726/2004], and where relevant, representatives of patients’ organisations in the relevant disease areas, healthcare professionals, academics and experts.
Amendment 606 #
Proposal for a directive
Article 84 – paragraph 1 – introductory part
Article 84 – paragraph 1 – introductory part
1. A regulatory data protection period of fourtwo and a half years shall be granted for a medicinal product with respect to a new therapeutic indication not previously authorised in the Union, provided that:
Amendment 608 #
Proposal for a directive
Article 22 – paragraph 1
Article 22 – paragraph 1
1. When preparing the environmental risk assessment (‘ERA’) to be submitted pursuant to Article 6(2), the applicant shall take into account the scientific guidelines on the environmental risk assessment of medicinal products for human use as referred to in paragraph 6, or provide the duly justified reasons for any divergence from the scientific guidelines to the Agency or, as appropriate to the competent authority of the Member State concerned, in a timely manner. Where available, the applicant shall take into account existing ERAs performed under other Union legislation.
Amendment 610 #
Proposal for a directive
Article 84 – paragraph 1 – point a
Article 84 – paragraph 1 – point a
(a) adequate non-clinical or clinical studies were carried out by the marketing authorisation applicant in relation to the therapeutic indication demonstrating that it is of significant clinical benefit, and
Amendment 612 #
Proposal for a directive
Article 22 – paragraph 2 – introductory part
Article 22 – paragraph 2 – introductory part
2. The ERA shall evaluate the possible risks to the environment due to the use and disposal of the medicinal product according to the requirements referred to in Annex II . It shall indicate whether the medicinal product or any of its ingredients or other constituents is one of the following substances according to the criteria of Annex I to the Regulation (EC) No 1272/2008:
Amendment 616 #
Proposal for a directive
Article 22 – paragraph 2 a (new)
Article 22 – paragraph 2 a (new)
2 a. With regards to risks resulting from manufacturing, the ERA shall provide information on discharged and emissions of the active susbtance(s) and other environmentally relevant susbtances according to the requirements referred to in Annex II.
Amendment 620 #
Proposal for a directive
Article 22 – paragraph 3
Article 22 – paragraph 3
3. The applicant shall also include in the ERA risk mitigation measures to avoid or where it is not possible, limit emissions to air, water and soil of pollutants listed in Directive 2000/60/EC, Directive 2006/118/EC, Directive 2008/105/EC and Directive 2010/75/EU or in the cases where risks to the environment are identified in the scientific guidelines drawn up by the Agency on the ERA requirements for medicinal products for human use as referred to in paragraph 5. The applicant shall provide detailed explanation that the proposed mitigation measures are appropriate and sufficient to address the identified risks to the environment.
Amendment 620 #
Proposal for a directive
Article 84 a (new)
Article 84 a (new)
Article84a Reporting of research and development costs from the marketing authorisation holder 1.Where the marketing authorisation holder benefits from data and market protection granted under this Directive it shall: (a) Upon request, submit to the Commission and/or the competent authorities of the Member States responsible for pricing and reimbursement an electronic report with detailed information on their expenditure in research and development activities related to the medicinal product. (b) make the report available within 30 days from the receipt of the request; (c) publish a summary of the report on the same webpage where the information described in Article 57 will be published. The link should be communicated to the competent authority of the Member State granting the marketing authorisation or, where appropriate, to the Agency. (d) ensure that the electronic report and lay summary are accurate and have been audited by an independent external auditor. 2. The Commission shall promote transparency and data sharing mechanisms regarding reimbursement prices of medicinal products by the Member States. 3. The Commission shall adopt delegated acts to lay down the methodology and format in which the information should be reported and published pursuant to paragraph 1.
Amendment 622 #
Proposal for a directive
Article 85 – paragraph 1 – introductory part
Article 85 – paragraph 1 – introductory part
Patent rights, or supplementary protection certificates under the [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted] shall not be regarded as infringed when a reference medicinal product is used for the purposes of:
Amendment 628 #
Proposal for a directive
Article 85 – paragraph 1 – point a – introductory part
Article 85 – paragraph 1 – point a – introductory part
(a) studies, trials and other activities are conducted to generate data for an application, forfor the purpose of:
Amendment 635 #
Proposal for a directive
Article 22 – paragraph 5
Article 22 – paragraph 5
5. The Agency shall draw up scientific guidelines in accordance with Article 138 of [revised Regulation No (EC) 726/2004], to specify technical details regarding the ERA requirements for medicinal products for human use including environmental risk mitigation measures thereof. Where appropriate, the Agency shall consult the European Chemical Agency (ECHA), the European Food Safety Authority (EFSA) and the European Environmental Agency (EEA) the European Centre of Disease Control (ECDC) and other relevant stakeholders, including those managing residues from medicinal products and wastewater treatment on the drafting of these scientific guidelines.
Amendment 636 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point i
Article 85 – paragraph 1 – point a – point i
(i) obtaining a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinalfor products and for subsequent variations;
Amendment 639 #
Proposal for a directive
Article 22 – paragraph 6 – subparagraph 1
Article 22 – paragraph 6 – subparagraph 1
The marketing authorisation holder shall update the ERA with new information without undue delay to the relevant competent authorities, in accordance with Article 90(2), if new information pertaining to the assessment criteria referred to in Article 29 becomes available and could lead to a change of the conclusions of the ERA, including updates on the emissions of the medicinal product in manufacturing effluents. The update shall include any relevant information from environmental monitoring, including monitoring under Directive 2000/60/EC, from eco-toxicity studies, from new or updated risk assessments under other Union legislation, as referred to in paragraph 1, the collation of sales data and environmental exposure data.
Amendment 640 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point ii
Article 85 – paragraph 1 – point a – point ii
(ii) conducting a health technology assessment as defined in Regulation (EU) 2021/2282;
Amendment 642 #
Proposal for a directive
Article 22 – paragraph 6 – subparagraph 2
Article 22 – paragraph 6 – subparagraph 2
For an ERA conducted prior to [OP please insert the date = 18 months after the date of entering into force of this Directive], the competent authority shall request the marketing authorisation holder to update the ERA if missing information has been identified for medicinal products potentially harmful to the environment and to update missing information in relation to risk mitigation measures referred to in paragraph 3.
Amendment 644 #
Proposal for a directive
Article 22 – paragraph 7
Article 22 – paragraph 7
7. For medicinal products referred to in Articles 9 to 12, the applicant may refer to ERA studies conducted for the reference medicinal product when preparing the ERA and shall provide any other data required in accordance with Annex II and the scientific guidelines referred to in the paragraph 5.
Amendment 647 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii
Article 85 – paragraph 1 – point a – point iii
(iii) obtaining pricing and reimbursement. approval;
Amendment 648 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii a (new)
Article 85 – paragraph 1 – point a – point iii a (new)
(iii a) participating in public and private procurement tenders of medicinal products for which the fulfillment of the obligations laid out in the tender will commence after the expiry of the relevant patents or supplementary protection certificates;
Amendment 652 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii b (new)
Article 85 – paragraph 1 – point a – point iii b (new)
(iii b) complying with any other regulatory or administrative requirements necessary for the purpose of placing the medicinal product on the Union market or for export in third countries markets, after expiration of the patent or supplementary protection certificate.
Amendment 654 #
Proposal for a directive
Article 23 – paragraph 1 – subparagraph 1
Article 23 – paragraph 1 – subparagraph 1
By [OP please insert the date = 3012 months after the date of the entry into force of this Directive] the Agency shall, after consultation with the competent authorities of the Member States, the European Chemical Agency (ECHA), the European Food Safety Authority (EFSA) and the European Environmental Agency (EEA), establish a programme for the ERA to be submitted in accordance with Article 22 of the medicinal products authorised before 30 October 2005 that have not been subject to any ERA and that the Agency has identified as potentially harmful to the environment in accordance with paragraph 2.
Amendment 660 #
Proposal for a directive
Article 85 – paragraph 1 – point b
Article 85 – paragraph 1 – point b
(b) the activities conducted exclusively for the purposes set out in point (a), mayshall cover the submission of the application for a marketing authorisation and the offering, manufacture, sale, supply, storage, import, export, use and purchase of patented medicinal products or processes, including by third party suppliers and service providers.
Amendment 663 #
Proposal for a directive
Article 23 – paragraph 3
Article 23 – paragraph 3
3. The marketing authorisation holders for medicinal products identified in the programme referred to in paragraph 1 shall submit the ERA to the Agency. The outcome of the assessment of the ERA including the dataa summary of ERA studies and their results as submitted by the marketing authorisation holder and the assessment of the ERA and scientific guidelines referred to in Article 22(5) shall be made publicly available by the Agency.
Amendment 666 #
Proposal for a directive
Article 23 – paragraph 4
Article 23 – paragraph 4
4. Where there are several medicinal products identified in the programme referred to in paragraph 1 that contain the same active substance and that are expected to pose the same risks to the environment, the competent authorities of the Member States or the Agency shall encourageinform and recommend the marketing authorisation holders of the possibility to conduct joint studies for the ERA, to minimise unnecessary duplication of data and use of animals. In this regard, to facilitate and foster the increased use of joint studies, the Agency shall oversee these in a cooridnating role, where necessary and appropriate.
Amendment 669 #
Proposal for a directive
Article 85 – paragraph 2
Article 85 – paragraph 2
This exception shall not cover the placing on the market of the medicinal products resulting from such activities before expiry of relevant patent or supplementary protection certificates.
Amendment 672 #
Proposal for a directive
Article 24 – paragraph 4
Article 24 – paragraph 4
4. The Agency in cooperation with the competent authorities of the Member States shall conduct a proof-of-concept pilot of ERA monographs to be completed within threewo years after entering into force of this Directive.
Amendment 672 #
Proposal for a directive
Article 85 a (new)
Article 85 a (new)
Article85a Prohibition on patent linkage 1. Member States shall not, when conducting regulatory or administrative procedures in regards to activities carried out in accordance with Article 85, enforce intellectual property rights as a valid ground for refusal, suspension, delay, withdrawal or revocation of marketing authorisation, pricing and reimbursement decisions or tender bids in regards to public and private procurement of medicinal products. 2. If the market authorization holder ceases to commercialise a medicinal product in the Union, the Commission shall have a public purchase option for all related intellectual property rights.
Amendment 677 #
Proposal for a directive
Article 86 a (new)
Article 86 a (new)
Article86a Measuring pharmaceutical access within the EU 1.The Commission, in collaboration with Member States, shall develop objective and specific indicators to measure pharmaceutical access within the EU. The indicators related to pharmaceutical access should include but not be limited to availability, health system and patient affordability and accesibility of medicines. (a) The Commission shall ensure that these indicators are evidence-based, measurable, and regularly reviewed to reflect the evolving healthcare landscape within the EU. Additionally, the Commission shall ensure that confidentiality of pricing and reimbursement data is overcome to avoid distorsion estimates. (b) The Commission, in collaboration with Member States, shall produce a quinquennial report on the state of pharmaceutical access within the Union. This report shall comprehensively analyse the indicators defined in paragraph 1, evaluating their effectiveness in gauging access to medicines. The Commission shall also establish a public database for annual update of paramenters defined in the quinquennial report.
Amendment 682 #
Proposal for a directive
Article 97 – paragraph 1 – point e a (new)
Article 97 – paragraph 1 – point e a (new)
(e a) facilitate harm reduction from adverse events through developing and implementing corrective patient safety plans for safe medicinal product administration and handling which can include the deployment of digital medication safety systems in hospitals and ambulatory care settings.
Amendment 684 #
Proposal for a directive
Article 104 – paragraph 2
Article 104 – paragraph 2
2. The marketing authorisation holder shall ensure that information to the public is presented objectively and is not misleading, and it is presented in a clear and adjusted language.
Amendment 686 #
Proposal for a directive
Article 105 – paragraph 2
Article 105 – paragraph 2
2. Marketing authorisation holders shall not refuse to consider reports of suspected adverse reactions received electronically or by any other appropriate means from patients, carers or other relevant persons, such as family members or healthcare professionals.
Amendment 688 #
Proposal for a directive
Article 106 – paragraph 1 – subparagraph 1
Article 106 – paragraph 1 – subparagraph 1
Each Member State shall record all suspected adverse reactions that occur in its territory and that are brought to its attention from healthcare professionals and patients. This shall include all authorised medicinal products and medicinal products used in accordance with Article 3, paragraphs 1 or 2. Member States shall involve patients and healthcare professionals, as appropriate, in the follow- up of any reports they receive in order to comply with Article 97(1), points (c) and (e), and shall seek to inform directly those stakeholders that reported a suspected adverse drug reaction on decisions taken in relation to the safety of the medicinal product.
Amendment 690 #
Proposal for a directive
Article 123 – paragraph 1 – point b
Article 123 – paragraph 1 – point b
(b) scientific guidance on post- authorisation efficacy studies, following the consultation process established under Article 162 of the [revised Regulation (EU) 726/2004].
Amendment 693 #
Proposal for a directive
Article 147 – paragraph 1 – subparagraph 1 – point a a (new)
Article 147 – paragraph 1 – subparagraph 1 – point a a (new)
(a a) maintain the market adequately supplied with the registered products, in an adequate and continuous maner, so that the needs of patients are covered;
Amendment 694 #
Proposal for a directive
Article 147 – paragraph 1 – subparagraph 1 – point g
Article 147 – paragraph 1 – subparagraph 1 – point g
(g) use only active substances that have been manufactured in accordance with good manufacturing practice for active substances and distributed in accordance with good distribution practices for active substances, which include reliable, constant and timely delivery of the active substances to the manufacturing authorization holders;
Amendment 695 #
(a) shall verify within 20 days whether the particulars and documentations submitted in support of the application comply with Articles 6 and 9 to 14 (‘validation’), and examine whether the conditions for issuing a marketing authorisation set out in Articles 43 to 45 are complied with;
Amendment 695 #
Proposal for a directive
Article 147 – paragraph 1 – subparagraph 1 – point j a (new)
Article 147 – paragraph 1 – subparagraph 1 – point j a (new)
(j a) comply with the risk mitigating measures in accordance with Article 22(4). In this regard, they shall comply and permit representatives of competent authorities of Member States to access their manufacturing premises, sites, and any outdoor facilities and effluents at any time. This obligation shall also apply where decentralised manufacturing or testing takes place.
Amendment 697 #
Proposal for a directive
Article 29 – paragraph 3
Article 29 – paragraph 3
3. Where the competent authority of the Member State considers that the marketing authorisation application is incomplete, or contains critical deficiencies that may prevent the evaluation of the medicinal product it shall inform the applicant accordingly and shall set a time limit of minimum 14 days for submitting the missing information and documentation. If the applicant fails to provide the missing information and documentation within the time limit set, the application shall be considered to have been withdrawn by default.
Amendment 697 #
Proposal for a directive
Article 147 – paragraph 1 – subparagraph 3
Article 147 – paragraph 1 – subparagraph 3
For the purposes of points (f) and (g), manufacturing authorisation holders shall verify compliance, respectively, by the manufacturer or distributors of active substances with good manufacturing practice and good distribution practices by conducting audits at the manufacturing and distribution sites of the manufacturer and distributors of active substances. Manufacturing authorisation holders shall verify such compliance either by themselves or through an entity acting on their behalf under a contract. Manufacturing authorisation holders may diversify their contracts with manufacturer or distributors of active substances if needed to ensure an adequate, constant and timely provision to comply with their public service obligations for supply.
Amendment 698 #
Proposal for a directive
Article 29 – paragraph 4 – subparagraph 2
Article 29 – paragraph 4 – subparagraph 2
The competent authority of the Member State shall summarise the deficiencies in writing. On this basis, the competent authority of the Member State shall inform the applicant accordingly and set a time limit of minimum 14 days to address the deficiencies. The application shall be suspended until the applicant addresses the deficiencies. If the applicant fails to address those deficiencies within the time limit set by the competent authority of the Member State, the application shall be considered as withdrawn by default.
Amendment 698 #
Proposal for a directive
Article 148 – paragraph 8 – introductory part
Article 148 – paragraph 8 – introductory part
8. TIn order to ensure the smooth functioning of the decentralised sites with activities relevant for other Union legal frameworks, the competent authority of the Member State supervising the decentralised site pursuant to paragraph 4 shall cooperaterdinate their activities and supervisory tasks with the relevant authorities responsible for the supervision of the manufacturing or testing activities under other Union acts as regards the following:
Amendment 699 #
Proposal for a directive
Article 148 – paragraph 8 a (new)
Article 148 – paragraph 8 a (new)
8 a. The competent authorities referred to paragraph 8 shall guarantee that the modalitities of coordination shall not adversely affect the preparation of SoHO therapies on a Member State level.
Amendment 700 #
Proposal for a directive
Article 148 – paragraph 9
Article 148 – paragraph 9
9. Where relevant, competent authorities of the Member State supervising the central and decentralised sites mayshall liaise with the competent authority of the Member State responsible for the supervision of the marketing authorisation.
Amendment 701 #
Proposal for a directive
Article 30 – paragraph 1
Article 30 – paragraph 1
Member States shall take all appropriate measures to ensure that the procedure for granting a marketing authorisation for medicinal products is completed within a maximum of 180 days (excluding clock stops) after the submission of a valid application from the date of validation of a marketing authorisation application.
Amendment 703 #
Proposal for a directive
Article 160 – paragraph 1 – introductory part
Article 160 – paragraph 1 – introductory part
The Commission mayshall adopt implementing acts in accordance with Article 214(2) to supplement this Directive by specifying:
Amendment 704 #
Proposal for a directive
Article 160 – paragraph 1 – point b a (new)
Article 160 – paragraph 1 – point b a (new)
(b a) the principles and measures on reducing the environmental impact of medicinal products and active substances in manufacturing and distribution
Amendment 705 #
Proposal for a directive
Article 34 – paragraph 3
Article 34 – paragraph 3
3. The applicant shall inform all the competent authorities of all Member States of its application at the time of submission. The competent authority of a Member State may request for justified public health reasonsshall have the possibility to to enter the procedure and shall inform the applicant and the competent authority of the reference Member State for the decentralised procedure of its request within 30 days from the date of submission of the application. The applicant shall provide the competent authorities of those Member States entering the procedure with the application without undue delay.
Amendment 705 #
Proposal for a directive
Article 160 – paragraph 2
Article 160 – paragraph 2
Where relevant, these principles shall be specified in coherencealigned with with any principles of good practices established under any other Union legal framework.
Amendment 707 #
Proposal for a directive
Article 34 – paragraph 4 – subparagraph 2
Article 34 – paragraph 4 – subparagraph 2
The competent authority of the reference Member State for the decentralised procedure shall summarise the deficiencies in writing. On this basis, the competent authority of the reference Member State for the decentralised procedure shall inform the applicant and the competent authorities of the Member States concerned accordingly and set a time limit of minimum 14 days to address the deficiencies. The application shall be suspended until the applicant addresses the deficiencies. If the applicant fails to address those deficiencies within the time limit set by the competent authority of the reference Member State for the decentralised procedure, the application shall be considered as withdrawn.
Amendment 709 #
Proposal for a directive
Article 34 – paragraph 5
Article 34 – paragraph 5
5. Within 120 days after validation of the application, the competent authority of the reference Member State for the decentralised procedure shall prepare an assessment report, a summary of product characteristics, the labelling and the package leaflet and shall send them to the Member States concerned and to the applicant. During this period, a competent authority of a Member State may request to recognise and enter the procedure after validation and shall inform the applicant and the competent authority of the reference Member State for the decentralised procedure.
Amendment 714 #
Proposal for a directive
Article 36 – paragraph 4
Article 36 – paragraph 4
4. The applicant shall inform the competent authorities of all Member States of its application at the time of submission. The competent authority of a Member State may request for justified public health reasonsshall have the possibility to enter the procedure and shall inform the applicant and the competent authority of the reference Member State for the mutual recognition procedure of its request within 30 days from the date of submission of the application. The applicant shall provide the competent authorities of those Member States entering the procedure with the application without undue delay.
Amendment 715 #
Proposal for a directive
Article 167 – paragraph 2
Article 167 – paragraph 2
2. The wholesale distributors of a medicinal product placed on the market in a Member State shall, within the limits of their responsibilities, ensure appropriate and continued supplies of that medicinal product, in a sufficient quantity and a timely manner, to pharmacies and persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered.
Amendment 716 #
Proposal for a directive
Article 36 – paragraph 4 a (new)
Article 36 – paragraph 4 a (new)
4 a. In order to examine an application submitted in accordance with Articles 6 and 9 to 14, the competent authorities of the Member States shall verify within 20 days whether the particulars and documentations submitted in support of the application comply with Articles 6 and 9 to 14 (‘validation’), and examine whether the conditions for issuing a marketing authorisation set out in Articles 43 to 45 are complied with;
Amendment 718 #
Proposal for a directive
Article 172 – paragraph 1 – point a
Article 172 – paragraph 1 – point a
(a) the natural or legal person offering the medicinal products is authorised or entitled to supply medicinal products to the public, also at a distance, in accordance with national legislation of the Member State in which that person is established and in accordance with national legislation of the Member State to which the products are supplied;
Amendment 719 #
Proposal for a directive
Chapter XII a (new)
Chapter XII a (new)
XII a Chapter XII(a) Public procurement of medicinal products Article 174a Procurement of medicinal products 1. Member States may consider strategic approaches when engaging in procurement procedures, including criteria beyond price, in line with Directive 2014/24/EU on public procurement. When doing so they may put in place practices supporting security of supply and availability of medicines including: a) preliminary market consultation; b) awarding multiple contracts to reduce the risk of supply disruptions and mantain a competitive environment; c) increased use of “most economically advantageous tender” (MEAT) award criteria in public tenders, using qualitative criteira such as security of supply and production in the EU/EEA or in countries with which the EU has concluded an agreement on government procurement; (d) ensuring that the duration of contracts is tailored to favour predictability of demand and long-term availability. Article 174b Joint procurement of medicinal products 1. The Commission and any of the Member States may engage, as contracting parties, in a joint procurement procedure with a view to the purchase of medicinal products. 2. A joint procurement procedure as referred to in paragraph 1 shall be preceded by a Joint Procurement Agreement between the parties determining the practical arrangements governing that procedure and the decision-making process with regard to the choice of the procedure, the joint procurement assessment as referred to in paragraph 3, point (c), the assessment of the tenders and the award of the contract. 3. The joint procurement procedure referred to in paragraph 1 of this Article shall comply with the following conditions: (a) participation in the joint procurement procedure is open to all Member States, European Free Trade Association States and Union candidate countries, as well as the Principality of Andorra, the Principality of Monaco, the Republic of San Marino and the Vatican City State, by way of derogation from Article 165(2) of Regulation (EU, Euratom) 2018/1046; (b) the rights and obligations of the countries referred to in point (a) that do not participate in the joint procurement are respected, in particular those relating to the protection and improvement of human health; (c) before the launch of a joint procurement procedure, the Commission prepares a joint procurement assessment which shall indicate the general envisaged conditions of the joint procurement procedure, including as regards possible restrictions to parallel procurement and negotiation activities by the participating countries for the medicinal product in question during the specific joint procurement procedure; that assessment shall take into account the need to ensure security of supply of medicinal products concerned to the participating countries. Based on the joint procurement assessment and the relevant information provided therein, such as on envisaged price ranges, manufacturers, delivery time frames and the proposed deadline for decision on participation, the parties to the Joint Procurement Agreement shall express their interest in participating at an early stage. Those parties to the Joint Procurement Agreement which have expressed their interest shall subsequently decide on their participation in the joint procurement procedure under the conditions jointly agreed with the Commission, taking into account the information proposed in the joint procurement assessment; (d) the joint procurement does not affect the internal market, does not constitute discrimination or a restriction of trade and does not cause distortion of competition; and (e) the joint procurement does not have any direct financial impact on the budget of the countries referred to in point (a) that do not participate in the joint procurement. 4. The Commission shall, in liaison with the Member States, ensure coordination and the exchange of information between the entities organising and participating in any action, including, but not limited to, joint procurement procedures for and development, stockpiling, distribution and donation of medicinal products, under different mechanisms established at Union level, in particular under: (a) stockpiling under rescEU referred to in Article 12 of Decision No 1313/2013/EU; (b) Regulation (EU) 2016/369; (c) the Pharmaceutical Strategy for Europe; (d) the EU4Health Programme established by Regulation (EU) 2021/522; (e) Regulation (EU) 2021/697 of the European Parliament and of the Council (34); and (f) other programmes and instruments supporting biomedical research and development at Union level for enhanced capacity and readiness to respond to cross-border threats and emergencies, such as measures adopted under Regulation (EU) 2022/2372. 5. The Commission shall inform the European Parliament about procedures concerning the joint procurement of medicinal products and, upon request, grant access to the contracts that are concluded as a result of those procedures, subject to the adequate protection of business secrecy, commercial relations and the interests of the Union. The Commission shall communicate information to the European Parliament regarding sensitive documents in accordance with Article 9(7) of Regulation (EC) No 1049/2001
Amendment 724 #
Proposal for a directive
Article 43 – paragraph 3
Article 43 – paragraph 3
3. The competent authorities of the Member States shall, without undue delay, make publicly available the national marketing authorisation together with the summary of product characteristics, the package leaflet, the antimicrobial stewardship plan and special information requirements referred to in Article 17 (1), as well as any conditions established in accordance with Articles 44, 45 and any obligations imposed subsequently in accordance with Article 17 (2) and Article 87, together with any deadlines for the fulfilment of those conditions and obligations for each medicinal product that they have authorised.
Amendment 728 #
Proposal for a directive
Article 188 – paragraph 5 – introductory part
Article 188 – paragraph 5 – introductory part
5. Where the competent authority of the Member State, namely the supervisory authority, considers it necessary, in particular where there are grounds for suspecting non-compliance with the rules of this Directive, including with the principles of good manufacturing practice and good distribution practices, referred to in Articles 160 and 161, or based on a risk assesment, it may have its official representatives carry out the measures referred to in paragraph 1, second subparagraph at the premises or on the activities of:
Amendment 729 #
Proposal for a directive
Article 188 – paragraph 5 – point d
Article 188 – paragraph 5 – point d
(d) distributors of medicinal products or manufacturers or distributors of active substances located in third countries;
Amendment 733 #
Proposal for a directive
Article 43 – paragraph 6
Article 43 – paragraph 6
6. The competent authorities of the Member States shall make the assessment report publicly available without undue delay, together with the reasons for their opinion, after deletion of any information of a commercially confidential nature, unless there is an overriding public interest in disclosure. The justification shall be provided separately for each therapeutic indication applied for.
Amendment 738 #
Proposal for a directive
Article 44 – paragraph 1 – subparagraph 1 – point g
Article 44 – paragraph 1 – subparagraph 1 – point g
(g) in case of medicinal products for which, on duly justified grounds described in the assessment report, there is substantial uncertainty as to the surrogate endpoint relation to the expected health outcome, where appropriate and relevant for the benefit-risk balance, with particular attention to new active substances and therapeutic indications, a post- authorisation obligation to substantiate the clinical benefit;
Amendment 738 #
Proposal for a directive
Article 200 – paragraph 4 – subparagraph 1
Article 200 – paragraph 4 – subparagraph 1
The competent authority of the Member State may process personal health data from sources other than clinical studies including the Eudravigilance database, electronic health data obtained pursuant to the applicable rules of the European Health Data Space to support their public health tasks and, in particular, the evaluation and monitoring to medicinal products, for the purpose of improving the robustness of the scientific assessment or verifying claims of the applicant or marketing authorisation holder. The competent authorities must put in place sufficient, effective and specific technical and organisational measures to safeguard the fundamental rights and interests of data subjects in line with Regulation (EU) 2016/679 and Regulation (EU) 2018/1725, including but not limited to clear and targeted data retention and deletion policies, state-of-the-art anonymisation and pseudonymisation requirements and techniques, confidentiality and data security measures, and access control mechanisms.
Amendment 741 #
Proposal for a directive
Article 201 – paragraph 2 a (new)
Article 201 – paragraph 2 a (new)
2 a. The Commission, in applying this Directive, in order to improve regulatory certainty and cross-sectoral cooperation it shall on an annual basis, or more frequently where deemed necessary, organise joint meetings between the Agency and the relevant advisory and regulatory bodies established under other Union legislation to assess emergeing trends and questions on the regulatory status of products and to find agreement on common regulatory status principles. The summaries and conclusions of these joint meetings shall be made publicly available, including the opinions and conclusions of each of the respective bodies.
Amendment 742 #
Proposal for a directive
Article 206 – paragraph 1 – subparagraph 1
Article 206 – paragraph 1 – subparagraph 1
Member States shall lay down the rules on penalties applicable to infringements of national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties must be effective, proportionate and dissuasive. Member States shall, without delay, and taking into consideration the provision in paragraph 4, notify the Commission of those rules and of those measures and shall notify without delay of any subsequent amendment affecting them.
Amendment 743 #
Proposal for a directive
Article 206 – paragraph 2 – point d
Article 206 – paragraph 2 – point d
(d) non-compliance with the provisions laid down in this Directive on pharmacovigilance, and the provisions laid down in paragraph 2 of Article 17 in relation to the stewardship plan for antimicrobials, and in Article 44 on national marketing authorisations subject to conditions;
Amendment 745 #
Proposal for a directive
Article 206 – paragraph 3 a (new)
Article 206 – paragraph 3 a (new)
3 a. The European Commission shall lay down criteria for establishing the penalties, taking into account paragraphs 1, 2 and 3, and the highest penalties laid down amongst Member States before the application of this Directive.
Amendment 747 #
Proposal for a directive
Article 207 – paragraph 1
Article 207 – paragraph 1
Member States shall ensure that appropriate collection systems are in place for medicinal products that are unused or have expired, and that the collected medicinal products are managed properly without any technically avoidable leakage to the environment.
Amendment 753 #
Proposal for a directive
Article 207 – paragraph 1 a (new)
Article 207 – paragraph 1 a (new)
By ... [18 months after the date of entry into force of this Directive], Member States shall draw up national plans including measures designed to: (a) monitor the rates of correct and incorrect disposal of unused and expired medicinal products; (b) inform the general public about the environmental risks associated with incorrect disposal of medicinal products, in particular those that contain substances referred to in Article 22(2); (c) inform healthcare professionals about the environmental risks associated with incorrect disposal of unused or expired medicinal products, in particular those that contain substances referred to in Article 22(2); (d) increase the rate of correct disposal of unused or expired medicinal products; and (e) designate public and private actors responsible for the collection systems referred to in paragraph 1.
Amendment 758 #
Proposal for a directive
Article 208 a (new)
Article 208 a (new)
Article208a Fostering research, innovation and production of medicinal products in the Union 1. The Commission shall establish an strategy to foster research, innovation and production of medicinal products in the Union, based on the results published in the report defined in paragraph 2. Member States shall be encouraged to participate in this strategy. 2. By... [one year after the date of entry into force of this Directive] the Commission shall present an impact assesment evaluating potential measures to be implemented at Union level, and at a Member State level to foster research, innovation and production of medicinal products in the Union. This report shall evaluate the effect of measures such as (a) funding and push and pull incentives directed to foster research and innovation in the Union, including public and private funding for preclinical and clinical research and innovation (b) public-private partnerships in research and innovation (c) regulatory support for public research and innovation entities (d) establishment of a public medicinal product production facility for products with low commertial interests (e) incentives for production inside the Union. Proposed measures shall be in line with developing a strategic autonomy for the Union regarding medicinal products.
Amendment 762 #
Proposal for a directive
Article 47 – paragraph 1 – point d
Article 47 – paragraph 1 – point d
(d) the environmental risk assessment is incomplete or insufficiently substantiated or the reason for the imcomplete nature of the ERA are not duly justified or subtantiated by the applicant or if the risks identified in the environmental risk assessment have not been sufficiently addressed by the applicant or by the risk mitigation measures by the applicant, in accordance Article 22 (3) this Directive;
Amendment 782 #
Proposal for a directive
Article 51 – paragraph 1 – point f
Article 51 – paragraph 1 – point f
(f) contains an active substance whichor any of its ingredients or constituent parts are persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative, or persistent, mobile and toxic, or very persistent and very mobile or listed in Annex X of Directive 2000/60/EC or Annex I of Directive 2006/118/EC for which medical prescription is required as risk minimisation measure with regard to the environment, unless the use of the medicinal product and the patient safety require otherwise.
Amendment 785 #
Proposal for a directive
Article 51 – paragraph 2
Article 51 – paragraph 2
2. Member States may set additional conditions on the prescription of antimicrobials, restrict the validity of medical prescription and limit the quantities prescribed to the amount required for the treatment or therapy concerned or submitting certain antimicrobial medicinal products to special medical prescription or restricted prescription.
Amendment 793 #
Proposal for a directive
Article 51 – paragraph 2 a (new)
Article 51 – paragraph 2 a (new)
2 a. Member States shall, wherever possible, provide for per unit prescription and dispensing for the treatment or therapy concerned.
Amendment 805 #
Proposal for a directive
Article 56 – paragraph 3 a (new)
Article 56 – paragraph 3 a (new)
3 a. For SoHO-derived medicinal products, which are obtained from altruistic and unpaid donations, Member States shall ensure, through public service obligations, that manufacturers, within the limits of their responsibilities, provide an appropriate and continuous supply to patients in each Member State.Member States shall negociate fair and transparent prices for SoHO-derived medicinal products and ensure that low-profit products are also available to patients and that there is a continuous investment on research and innovation for those products. When medicinal products are derived from donated SoHOs, manufacturers must, as for public service obligation in the Member States, report annually to the authorities the amount of processed locally-collected SoHOs and medicinal products prepared from them.
Amendment 806 #
Proposal for a directive
Article 56 – paragraph 4
Article 56 – paragraph 4
4. The marketing authorisation holder shall, at all stages of manufacturing and distribution, within the limits of its responsability, ensure that the starting materials and ingredients of the medicinal products and the medicinal products themselves comply with the requirements of this Directive and, where relevant, the [revised Regulation (EC) No 726/2004] and other Union law and shall verify that such requirements are met.
Amendment 807 #
Proposal for a directive
Article 56 – paragraph 7
Article 56 – paragraph 7
7. Where the marketing authorisation holder considers or has reason to believe that the medicinal product it has made available on the market is not in conformity with the marketing authorisation or this Directive and the [revised Regulation (EC) No 726/2004] it shall immediately take the necessary corrective actions to bring that medicinal product into conformity, to withdraw it or recall it, as appropriate, in consultation with the competent authorities. The marketing authorisation holder shall immediately inform the competent authorities and the distributors concerned to that effect.
Amendment 812 #
Proposal for a directive
Article 57 – title
Article 57 – title
Responsibility to report on public financial support and cost data for all applicable research and development activities of medicinal products
Amendment 1212 #
Proposal for a directive
Article 84 – paragraph 1 – introductory part
Article 84 – paragraph 1 – introductory part
1. A regulatory data protection period of fourtwo and a half years shall be granted for a medicinal product with respect to a new therapeutic indication not previously authorised in the Union, provided that:
Amendment 1227 #
Proposal for a directive
Article 84 – paragraph 1 – point a
Article 84 – paragraph 1 – point a
(a) adequate non-clinical or clinical studies were carried out by the marketing authorisation applicant in relation to the therapeutic indication demonstrating that it is of significant clinical benefit, and
Amendment 1242 #
Proposal for a directive
Article 84 a (new)
Article 84 a (new)
Article84a Reporting of research and development costs from the marketing authorisation holder 1. Where the marketing authorisation holder benefits from data and market protection granted under this Directive it shall: (a) Upon request, submit to the Commission and/or the competent authorities of the Member States responsible for pricing and reimbursement an electronic report with detailed information on their expenditure in research and development activities related to the medicinal product; (b) make the report available within 30 days from the receipt of the request; (c) publish a summary of the report on the same webpage where the information described in Article 57 will be published. The link should be communicated to the competent authority of the Member State granting the marketing authorisation or, where appropriate, to the Agency; (d) ensure that the electronic report and lay summary are accurate and have been audited by an independent external auditor. 2. The Commission shall promote transparency and data sharing mechanisms regarding reimbursement prices of medicinal products by the Member States. 3. The Commission shall adopt delegated acts to lay down the methodology and format in which the information should be reported and published pursuant to paragraph 1.
Amendment 1251 #
Proposal for a directive
Article 85 – paragraph 1 – introductory part
Article 85 – paragraph 1 – introductory part
Patent rights, or supplementary protection certificates under the [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted] shall not be regarded as infringed when a reference medicinal product is used for the purposes of:
Amendment 1261 #
Proposal for a directive
Article 85 – paragraph 1 – point a – introductory part
Article 85 – paragraph 1 – point a – introductory part
(a) studies, trials and other activities are conducted to generate data for an application, forfor the purpose of:
Amendment 1274 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point i
Article 85 – paragraph 1 – point a – point i
(i) obtaining a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinalfor products and for subsequent variations;
Amendment 1287 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point ii
Article 85 – paragraph 1 – point a – point ii
(ii) conducting a health technology assessment as defined in Regulation (EU) 2021/2282;
Amendment 1298 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii
Article 85 – paragraph 1 – point a – point iii
(iii) obtaining pricing and reimbursement. approval;
Amendment 1299 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii a (new)
Article 85 – paragraph 1 – point a – point iii a (new)
(iii a) participating in public and private procurement tenders of medicinal products for which the fulfillment of the obligations laid out in the tender will commence after the expiry of the relevant patents or supplementary protection certificates;
Amendment 1307 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii b (new)
Article 85 – paragraph 1 – point a – point iii b (new)
(iii b) complying with any other regulatory or administrative requirements necessary for the purpose of placing the medicinal product on the Union market or for export in third countries markets, after expiration of the patent or supplementary protection certificate.
Amendment 1324 #
Proposal for a directive
Article 85 – paragraph 1 – point b
Article 85 – paragraph 1 – point b
(b) the activities conducted exclusively for the purposes set out in point (a), mayshall cover the submission of the application for a marketing authorisation and the offering, manufacture, sale, supply, storage, import, export, use and purchase of patented medicinal products or processes, including by third party suppliers and service providers.
Amendment 1340 #
Proposal for a directive
Article 85 – paragraph 2
Article 85 – paragraph 2
This exception shall not cover the placing on the market of the medicinal products resulting from such activities before expiry of relevant patent or supplementary protection certificates.
Amendment 1348 #
Proposal for a directive
Article 85 a (new)
Article 85 a (new)
Article85a Prohibition on patent linkage 1. Member States shall not, when conducting regulatory or administrative procedures in regards to activities carried out in accordance with Article 85, enforce intellectual property rights as a valid ground for refusal, suspension, delay, withdrawal or revocation of marketing authorisation, pricing and reimbursement decisions or tender bids in regards to public and private procurement of medicinal products. 2. If the market authorization holder ceases to commercialise a medicinal product in the Union, the Commission shall have a public purchase option for all related intellectual property rights.
Amendment 1352 #
Proposal for a directive
Article 86 a (new)
Article 86 a (new)
Article86a Measuring pharmaceutical access within the EU 1.The Commission, in collaboration with Member States, shall develop objective and specific indicators to measure pharmaceutical access within the EU. The indicators related to pharmaceutical access should include but not be limited to availability, health system and patient affordability and accesibility of medicines. (a) The Commission shall ensure that these indicators are evidence-based, measurable, and regularly reviewed to reflect the evolving healthcare landscape within the EU. Additionally, the Commission shall ensure that confidentiality of pricing and reimbursement data is overcome to avoid distorsion estimates. (b) The Commission, in collaboration with Member States, shall produce a quinquennial report on the state of pharmaceutical access within the Union. This report shall comprehensively analyse the indicators defined in paragraph 1, evaluating their effectiveness in gauging access to medicines. The Commission shall also establish a public database for annual update of paramenters defined in the quinquennial report.
Amendment 1370 #
Proposal for a directive
Article 97 – paragraph 1 – point e a (new)
Article 97 – paragraph 1 – point e a (new)
(e a) facilitate harm reduction from adverse events through developing and implementing corrective patient safety plans for safe medicinal product administration and handling which can include the deployment of digital medication safety systems in hospitals and ambulatory care settings.
Amendment 1379 #
Proposal for a directive
Article 104 – paragraph 2
Article 104 – paragraph 2
2. The marketing authorisation holder shall ensure that information to the public is presented objectively and is not misleading, and it is presented in a clear and adjusted language.
Amendment 1381 #
Proposal for a directive
Article 105 – paragraph 2
Article 105 – paragraph 2
2. Marketing authorisation holders shall not refuse to consider reports of suspected adverse reactions received electronically or by any other appropriate means from patients, carers or other relevant persons, such as family members or healthcare professionals.
Amendment 1386 #
Each Member State shall record all suspected adverse reactions that occur in its territory and that are brought to its attention from healthcare professionals and patients. This shall include all authorised medicinal products and medicinal products used in accordance with Article 3, paragraphs 1 or 2. Member States shall involve patients and healthcare professionals, as appropriate, in the follow- up of any reports they receive in order to comply with Article 97(1), points (c) and (e), and shall seek to inform directly those stakeholders that reported a suspected adverse drug reaction on decisions taken in relation to the safety of the medicinal product.
Amendment 1404 #
Proposal for a directive
Article 123 – paragraph 1 – point b
Article 123 – paragraph 1 – point b
(b) scientific guidance on post- authorisation efficacy studies, following the consultation process established under Article 162 of the [revised Regulation (EU) 726/2004].
Amendment 1407 #
Proposal for a directive
Chapter X – title
Chapter X – title
X Homeopathic medicinal products and tTraditional herbal medicinal products
Amendment 1408 #
Proposal for a directive
Chapter X – Section 1
Chapter X – Section 1
Amendment 1409 #
Proposal for a directive
Article 125
Article 125
Amendment 1410 #
Proposal for a directive
Article 126
Article 126
Amendment 1411 #
Proposal for a directive
Article 127
Article 127
Amendment 1412 #
Proposal for a directive
Article 128
Article 128
Application of decentralised and mutual recognition procedures to homeopathic 1. Article 38, paragraphs 4 and 6, Articles 39 to 42 and 95 shall not apply to the homeopathic medicinal products referred to in Article 126. 2. Chapter III, Sections 3 to 5, shall not apply to the homeopathic medicinal products referred to in Article 133(2).rticle 128 deleted medicinal products
Amendment 1413 #
Proposal for a directive
Article 129
Article 129
Amendment 1414 #
Proposal for a directive
Article 130
Article 130
Amendment 1415 #
Proposal for a directive
Article 131
Article 131
Amendment 1416 #
Amendment 1417 #
Proposal for a directive
Article 133
Article 133
Amendment 1418 #
Proposal for a directive
Article 134 – paragraph 1 – subparagraph 1 – point a
Article 134 – paragraph 1 – subparagraph 1 – point a
(a) they have therapeutic indications exclusively appropriate to traditional herbal medicinal products that, by virtue of their composition and purpose, are intended and designed for use without the supervision of a medical practitioner for diagnostic purposes or for prescription or monitoring of treatment;
Amendment 1419 #
Proposal for a directive
Article 134 – paragraph 1 – subparagraph 1 – point a a (new)
Article 134 – paragraph 1 – subparagraph 1 – point a a (new)
(a a) they are composed of plants with a known natural therapeutic properties;
Amendment 1420 #
Proposal for a directive
Article 134 – paragraph 1 – subparagraph 1 – point b
Article 134 – paragraph 1 – subparagraph 1 – point b
(b) they are exclusively for administration in accordance with a specified strength and posology that do not present risks for human health;
Amendment 1421 #
Proposal for a directive
Article 134 – paragraph 3
Article 134 – paragraph 3
3. However, in cases where the competent authorities judge that a herbal medicinal product that fulfils the conditions laid down in paragraph 1 (‘traditional herbal medicinal product’) fulfils the criteria for a national marketing authorisation in accordance with Article 5 or for a simplified registration in accordance with Article 126, the provisions of this Section shall not apply.
Amendment 1422 #
Proposal for a directive
Article 139 – paragraph 1
Article 139 – paragraph 1
1. The Commission shall adopt implementingdelegated acts to establish a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products, taking into account the draft list prepared by the herbal medicinal products working group. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2). The list shall contain, with regard to each herbal substance, the therapeutic indication, the specified strength and the posology, the route of administration, the adverse effects, the confirmed and potential interactions with other medicinal products, foods or traditional herbal medicinal products, the contraindications and any other information necessary for the safe use of the herbal substance as a traditional herbal medicinal product.
Amendment 1423 #
Proposal for a directive
Article 140 – paragraph 1
Article 140 – paragraph 1
1. Article 1(5), points (a) and (b) and Article 1(10), point (c), Articles 6 to 8, 29, 30, 44, 46, 90, 97, 155, Article 188, paragraphs 1 and 11, Articles 191, 195, 196, 198, 199(2), 202, 203 and 204 and Chapters IX and XI of this Directive as well as Commission Directive 2003/94/EC77[1] shall apply, mutadis mutandis, to traditional-use registrations granted under this Section. _________________ 77 Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (OJ L 262, 14.10.2003, p. 22).
Amendment 1424 #
Proposal for a directive
Article 140 – paragraph 2 – subparagraph 1 – point a
Article 140 – paragraph 2 – subparagraph 1 – point a
(a) the product is a traditional herbal medicinal product for use in specified therapeutic indication(s) exclusively based upon long-standing use; and with possible adverse effects;
Amendment 1425 #
Proposal for a directive
Article 140 – paragraph 2 – subparagraph 1 – point b
Article 140 – paragraph 2 – subparagraph 1 – point b
(b) the user should consult a doctor or a qualified healthcare practitioner if the symptoms persist during the use of the traditional herbal medicinal product or if adverse effects not mentioned or not in the package leaflet occur.; and
Amendment 1426 #
Proposal for a directive
Article 140 – paragraph 2 – subparagraph 1 – point b a (new)
Article 140 – paragraph 2 – subparagraph 1 – point b a (new)
(b a) herbal medicinal products may be contraindicated in some people and may produce pharmacological interactions with other medications, altering their safety and efficacy. Consult a doctor or a qualified healthcare practitioner.
Amendment 1427 #
Proposal for a directive
Article 140 – paragraph 3
Article 140 – paragraph 3
3. In addition to the requirements set out in Chapter XIII, any advertisement for a traditional herbal medicinal product registered under this Section shall contain the following statement: Traditional herbal medicinal product for use in specified therapeutic indication(s) exclusively based upon long-standing use, with possible adverse effects, contraindications and interactions with other medicines. For more information, consult a healthcare professional.
Amendment 1433 #
Proposal for a directive
Article 147 – paragraph 1 – subparagraph 1 – point j a (new)
Article 147 – paragraph 1 – subparagraph 1 – point j a (new)
(j a) comply with the risk mitigating measures in accordance with Article 22(4). In this regard, they shall comply and permit representatives of competent authorities of Member States to access their manufacturing premises, sites, and any outdoor facilities and effluents at any time. This obligation shall also apply where decentralised manufacturing or testing takes place.
Amendment 1435 #
Proposal for a directive
Article 148 – paragraph 8 – introductory part
Article 148 – paragraph 8 – introductory part
8. TIn order to ensure the smooth functioning of the decentralised sites with activities relevant for other Union legal frameworks, the competent authority of the Member State supervising the decentralised site pursuant to paragraph 4 shall cooperaterdinate their activities and supervisory tasks with the relevant authorities responsible for the supervision of the manufacturing or testing activities under other Union acts as regards the following:
Amendment 1436 #
Proposal for a directive
Article 148 – paragraph 8 a (new)
Article 148 – paragraph 8 a (new)
8 a. The competent authorities referred to paragraph 8 shall guarantee that the modalitities of coordination shall not adversely affect the preparation of SoHO therapies on a Member State level.
Amendment 1437 #
Proposal for a directive
Article 148 – paragraph 9
Article 148 – paragraph 9
9. Where relevant, competent authorities of the Member State supervising the central and decentralised sites mayshall liaise with the competent authority of the Member State responsible for the supervision of the marketing authorisation.
Amendment 1440 #
Proposal for a directive
Article 160 – paragraph 1 – introductory part
Article 160 – paragraph 1 – introductory part
The Commission mayshall adopt implementing acts in accordance with Article 214(2) to supplement this Directive by specifying:
Amendment 1442 #
Proposal for a directive
Article 160 – paragraph 1 – point b a (new)
Article 160 – paragraph 1 – point b a (new)
Amendment 1444 #
Proposal for a directive
Article 160 – paragraph 2
Article 160 – paragraph 2
Where relevant, these principles shall be specified in coherencealigned with with any principles of good practices established under any other Union legal framework.
Amendment 1455 #
Proposal for a directive
Article 167 – paragraph 2
Article 167 – paragraph 2
2. The wholesale distributors of a medicinal product placed on the market in a Member State shall, within the limits of their responsibilities, ensure appropriate and continued supplies of that medicinal product in a sufficient quantity to pharmacies and persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered.
Amendment 1460 #
Proposal for a directive
Article 172 – paragraph 1 – point a
Article 172 – paragraph 1 – point a
(a) the natural or legal person offering the medicinal products is authorised or entitled to supply medicinal products to the public, also at a distance, in accordance with national legislation of the Member State in which that person is established and in accordance with national legislation of the Member State to which the products are supplied;
Amendment 1461 #
Proposal for a directive
Chapter XII a (new)
Chapter XII a (new)
Amendment 1462 #
Proposal for a directive
Article 175 – paragraph 1 – subparagraph 2 – point e
Article 175 – paragraph 1 – subparagraph 2 – point e
(e) the provision of inducements to prescribe or supply medicinal products by the gift, offer or promise of any benefit or bonus, whether in money or in kind, except when their intrinsic value is minimal;
Amendment 1468 #
Proposal for a directive
Article 176 – paragraph 3 – point b
Article 176 – paragraph 3 – point b
(b) shall be accurate, verifiable and, not be misleading. or omit any key information without which could be mislead;
Amendment 1469 #
Proposal for a directive
Article 176 – paragraph 3 – point b a (new)
Article 176 – paragraph 3 – point b a (new)
(b a) shall not induce to an excesive or abusive use of the medicinal product.
Amendment 1470 #
Proposal for a directive
Article 176 – paragraph 4
Article 176 – paragraph 4
4. Any form of advertising that aims to highlight negatively another medicinal product shall be prohibited. Advertising that suggests that a medicinal product is safer or more effective than another medicinal product shall also be prohibited, unless demonstrated and supported by the summary of product characteristics.
Amendment 1477 #
Proposal for a directive
Article 177 – paragraph 1 – point b a (new)
Article 177 – paragraph 1 – point b a (new)
(b a) contain substances that are known to produce adictive behaviours;
Amendment 1483 #
Proposal for a directive
Article 177 – paragraph 1 – point b b (new)
Article 177 – paragraph 1 – point b b (new)
(b b) are an antimicrobial.
Amendment 1485 #
Proposal for a directive
Article 177 – paragraph 2
Article 177 – paragraph 2
2. Medicinal products may be advertised to the general public where, by virtue of their composition and purpose, they are intended and designed for use without the obligatory intervention of a medical practitioner for diagnostic purposes or for the prescription or monitoring of treatment, with the advice of thea medical practitioner or a pharmacist, if necessary.
Amendment 1494 #
Proposal for a directive
Article 177 – paragraph 3
Article 177 – paragraph 3
3. Member States shall be entitled to ban, anytime on their territory, advertising to the general public of medicinal products othe cost of which may be reimbursedr than those referred to in paragraph 1.
Amendment 1495 #
Proposal for a directive
Article 177 – paragraph 4
Article 177 – paragraph 4
4. The prohibition contained in paragraph 1 shall not apply to vaccination campaigns carried out by the industry and approved by the competent authorities of the Member States.
Amendment 1503 #
Proposal for a directive
Article 178 – paragraph 1 – point b – point iii
Article 178 – paragraph 1 – point b – point iii
(iii) an express, legible invitation to read carefully the instructions on the package leaflet or on the outer packaging, as the case may be, and to consult a medical practitioner or a pharmacist for extended information.
Amendment 1504 #
Proposal for a directive
Article 178 – paragraph 1 a (new)
Article 178 – paragraph 1 a (new)
1 a. Any indirect advertising included, whether intentional or not, in any type of communication whose objective is not expressely and obviously advertising shall be prohibited. This includes any mention to specific medicinal products in i.e. social media, television programms or media platforms.
Amendment 1506 #
Proposal for a directive
Article 178 – paragraph 2 a (new)
Article 178 – paragraph 2 a (new)
2 a. The European Commission shall adopt implementing acts with specific requirements in relation to the advertising of medicinal products through social media, and consumers’ exposure to such type of content in that platform.
Amendment 1508 #
Proposal for a directive
Article 179 – paragraph 1 – point h
Article 179 – paragraph 1 – point h
(h) suggests that the safety or efficacy of the medicinal product is due to the fact that it is natural and/or not chemical;
Amendment 1510 #
Proposal for a directive
Article 183 – paragraph 1
Article 183 – paragraph 1
1. Where medicinal products are being promoted to persons qualified to prescribe or supply them, no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to such persons unless they are inexpensive and relevant to the practice of medicine or pharmacy.
Amendment 1512 #
Proposal for a directive
Article 185 – paragraph 1 – point g
Article 185 – paragraph 1 – point g
(g) no samples of medicinal products containing substances classified as psychotropic or narcotic within the meaning of international conventions, or those known to produce adictive behaviours, may be supplied.
Amendment 1518 #
Proposal for a directive
Article 186 – paragraph 1
Article 186 – paragraph 1
1. Member States shall ensure that there are adequate and effective methods to monitor the advertising of medicinal products. Such methods, which mayshall be based on a system of prior vetting, at least for advertisements to the general public, shall in any event include legal provisions under which persons or organisations regarded under national law as having a legitimate interest in prohibiting any advertisement inconsistent with this Chapter, may take legal action against such advertisement, or bring such advertisement before the competent authority of the Member State either to decide on complaints or to initiate appropriate legal proceedings.
Amendment 1525 #
Proposal for a directive
Article 188 – paragraph 1 – subparagraph 1
Article 188 – paragraph 1 – subparagraph 1
The competent authority of the Member State concerned, namely the supervisory authority, shall, in cooperation with the Agency and where relevant, other Member States, ensure compliance with the rules of this Directive, namely the principles of good manufacturing practice and good distribution practices referred to in Articles 160 and 161.
Amendment 1526 #
Proposal for a directive
Article 188 – paragraph 3 – introductory part
Article 188 – paragraph 3 – introductory part
3. The competent authority of the Member State, namely the supervisory authority, shall ensure that the measures referred to in paragraph 1, second subparagraph, are carried out by the official representatives of the competent authority of the Member State concerned:
Amendment 1527 #
Proposal for a directive
Article 188 – paragraph 5 – introductory part
Article 188 – paragraph 5 – introductory part
5. Where the competent authority of the Member State, namely the supervisory authority, considers it necessary, in particular where there are grounds for suspecting non-compliance with the rules of this Directive, including with the principles of good manufacturing practice and good distribution practices, referred to in Articles 160 and 161, or based on a risk assesment, it may have its official representatives carry out the measures referred to in paragraph 1, second subparagraph at the premises or on the activities of:
Amendment 1528 #
Proposal for a directive
Article 188 – paragraph 5 – point d
Article 188 – paragraph 5 – point d
(d) distributors of medicinal products or manufacturers or distributors of active substances located in third countries;
Amendment 1529 #
Proposal for a directive
Article 188 – paragraph 7 – point a a (new)
Article 188 – paragraph 7 – point a a (new)
(a a) Examine any documents and records to verify compliance with the particulars of this Directive , and obtain evidence, such as copies of documents, photographs or videos.
Amendment 1530 #
Proposal for a directive
Article 189 – paragraph 1 – subparagraph 1
Article 189 – paragraph 1 – subparagraph 1
Upon request by one or more competent authorities of the Member States, inspections referred to in Article 188, paragraphs 3 and 5, may be carried out by official representatives from more than one Member State, together with the inspectors of the Agency, if specifically requested by the aforementioned competent authorities, in accordance with Article 52(2), point (a) of [revised Regulation (EC) 726/2004] (‘the joint inspection’).
Amendment 1531 #
Proposal for a directive
Article 189 – paragraph 1 – subparagraph 2 – point a
Article 189 – paragraph 1 – subparagraph 2 – point a
(a) it is demonstrated, or there are reasonable ground for suspecting, that the activities carried out on the territory of the Member State receiving the request pose a risk to the safety and quality in the Member State of the competent authority requesting the joint inspection, and the supervisory authority receiving the request has not performed an inspection to verify these suspects;
Amendment 1532 #
Proposal for a directive
Article 189 – paragraph 1 – subparagraph 2 – point c
Article 189 – paragraph 1 – subparagraph 2 – point c
(c) the competent authority of the Member State receiving the request agrees that there are other reasonable grounds such as training of inspectors, sharing of good practice, for for conducting a joint inspection.
Amendment 1533 #
Proposal for a directive
Article 189 – paragraph 2 – point b
Article 189 – paragraph 2 – point b
(b) the roles of the participating inspectors during and following the inspection, including the designation of an authority leading the inspection, if the supervisory authority refuses to lead the inspection;
Amendment 1534 #
Proposal for a directive
Article 192 – paragraph 1
Article 192 – paragraph 1
For the purpose of implementing Article 191, Member States may require manufacturers of immunological products and of medicinal products derived from substances of human origin to submit to a competent authority of the Member States copies of all the control reports signed by the qualified person in accordance with Article 153.
Amendment 1535 #
Proposal for a directive
Article 193 – paragraph 1 – subparagraph 1
Article 193 – paragraph 1 – subparagraph 1
to submit samples from each batch of the bulk and/or the medicinal product for examination by an Official Medicines Control Laboratory or a laboratory that a Member State has designated for that purpose before release on to the market unless the competent authority of another Member State has previously examined the batch in question and declared it to be in conformity with the approved specifications. In such a case the declaration of conformity issued by another Member States shall be directly recognised. Member States shall ensure that any such examination is completed within 360 days of the receipt of the samples and documentation of the controls carried out by the marketing authorisation holder in accordance with article 191.
Amendment 1537 #
Proposal for a directive
Article 193 – paragraph 2
Article 193 – paragraph 2
2. Where, in the interests of public health, the laws of a Member State so provide, the competent authorities of the Member State may require the marketing authorisation holder for medicinal products derived from human blood or human plasma to submit samples from each batch of the bulk and/or the medicinal product for testing by an Official Medicines Control Laboratory or a laboratory that a Member State has designated for that purpose before being released into free circulationto the market, unless the competent authorities of another Member State have previously examined the batch in question and declared it to be in conformity with the approved specifications. In such a case the declaration of conformity issued by another Member State shall be recognised. Member States shall ensure that any such examination is completed within 60 calendar days of the receipt of the samples and documentation of the controls carried out by the marketing authorisation holder in accordance with article 191.
Amendment 1538 #
Proposal for a directive
Article 194 – title
Article 194 – title
Processes for the preparation of medicinal products derived from human blood orsubstances of human plasmaorigin
Amendment 1539 #
Proposal for a directive
Article 194 – paragraph 1
Article 194 – paragraph 1
1. Member States shall take all necessary measures to ensure that the manufacturing and purifying processes used in the preparation of medicinal products derived from human blood orsubstances of human plasmaorigin are properly validated, attain batch-to-batch consistency and guarantee, insofar as the state of technology permits, the absence of specific viralrisks for the human health, including contaminations..
Amendment 1541 #
Proposal for a directive
Article 194 – paragraph 2
Article 194 – paragraph 2
2. To this end manufacturers shall notify the competent authorities of the Member States of the methods used to reduce or eliminate pathogenic viruses liable to be transmitted by medicinal productensure the quality and safety of the substances of human origin, as descrivbed from human blood or human plasmain Regulation (EU) No [SoHO Regulation]. The competent authority of the Member State may submit samples of the bulk and/or the medicinal product for testing by a State laboratory or a laboratory designated for that purpose, either during the examination of the application pursuant to Article 29, or after a marketing authorisation has been granted.
Amendment 1564 #
Proposal for a directive
Article 200 – paragraph 4 – subparagraph 1
Article 200 – paragraph 4 – subparagraph 1
The competent authority of the Member State may process personal health data from sources other than clinical studies including the Eudravigilance database, electronic health data obtained pursuant to the applicable rules of the European Health Data Space to support their public health tasks and, in particular, the evaluation and monitoring to medicinal products, for the purpose of improving the robustness of the scientific assessment or verifying claims of the applicant or marketing authorisation holder. The competent authorities must put in place sufficient, effective and specific technical and organisational measures to safeguard the fundamental rights and interests of data subjects in line with Regulation (EU) 2016/679 and Regulation (EU) 2018/1725, including but not limited to clear and targeted data retention and deletion policies, state-of-the-art anonymisation and pseudonymisation requirements and techniques, confidentiality and data security measures, and access control mechanisms.
Amendment 1569 #
Proposal for a directive
Article 201 – paragraph 2 a (new)
Article 201 – paragraph 2 a (new)
2 a. The Commission, in applying this Directive, in order to improve regulatory certainty and cross-sectoral cooperation it shall on an annual basis, or more frequently where deemed necessary, organise joint meetings between the Agency and the relevant advisory and regulatory bodies established under other Union legislation to assess emergeing trends and questions on the regulatory status of products and to find agreement on common regulatory status principles. The summaries and conclusions of these joint meetings shall be made publicly available, including the opinions and conclusions of each of the respective bodies.
Amendment 1571 #
Proposal for a directive
Article 206 – paragraph 1 – subparagraph 1
Article 206 – paragraph 1 – subparagraph 1
Member States shall lay down the rules on penalties applicable to infringements of national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties must be effective, proportionate and dissuasive. Member States shall, without delay, and taking into consideration the provision in paragraph 4, notify the Commission of those rules and of those measures and shall notify without delay of any subsequent amendment affecting them.
Amendment 1574 #
Proposal for a directive
Article 206 – paragraph 2 – point d
Article 206 – paragraph 2 – point d
(d) non-compliance with the provisions laid down in this Directive on pharmacovigilance, and the provisions laid down in paragraph 2 of Article 17 in relation to the stewardship plan for antimicrobials, and in Article 44 on national marketing authorisations subject to conditions;
Amendment 1581 #
Proposal for a directive
Article 206 – paragraph 3 a (new)
Article 206 – paragraph 3 a (new)
3 a. The European Commission shall lay down criteria for establishing the penalties, taking into account paragraphs 1, 2 and 3, and the highest penalties laid down amongst Member States before the application of this Directive.
Amendment 1585 #
Proposal for a directive
Article 207 – paragraph 1
Article 207 – paragraph 1
Member States shall ensure that appropriate collection systems are in place for medicinal products that are unused or have expired, and that the collected medicinal products are managed properly without any technically avoidable leakage to the environment.
Amendment 1587 #
Proposal for a directive
Article 207 – paragraph 1 – point 1 (new)
Article 207 – paragraph 1 – point 1 (new)
(1) By ... [18 months after the date of entry into force of this Directive], Member States shall draw up national plans including measures designed to: (a) monitor the rates of correct and incorrect disposal of unused and expired medicinal products; (b) inform the general public about the environmental risks associated with incorrect disposal of medicinal products, in particular those that contain substances referred to in Article 22(2); (c) inform healthcare professionals about the environmental risks associated with incorrect disposal of unused or expired medicinal products, in particular those that contain substances referred to in Article 22(2); (d) increase the rate of correct disposal of unused or expired medicinal products;and (e) designate public and private actors responsible for the collection systems referred to in paragraph 1.
Amendment 1592 #
Proposal for a directive
Article 208 – paragraph 1
Article 208 – paragraph 1
1. In order to guarantee independence and transparency, the Member States shall ensure that members of staff of the competent authority responsible for granting authorisations, rapporteurs and experts concerned with the authorisation and surveillance of medicinal products have no financial or other interests in the pharmaceutical industry that could affect their impartiality. These persons shall make an annual declaration of their financial interests, which shall be made publicly available.