Activities of Tiemo WÖLKEN related to 2023/0131(COD)
Reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006
Amendments (55)
Amendment 202 #
Proposal for a regulation
Recital -1 (new)
Recital -1 (new)
(-1) Ensuring that Europeans receive the medicines they need, when they need them, regardless of where they live in the EU, is a central objective of the European Health Union. Boosting the competitiveness of the European pharmaceutical industry, whilst also ensuring better availability of medicines and more equal and timely access for patients, is a key deliverable of the proposed EU pharmaceutical reform.
Amendment 229 #
Proposal for a regulation
Recital 20
Recital 20
(20) Promising medicinal products that have the potential to significantly address patients’ unmet medical needs should benefit from early and enhanced scientific support, including through supporting innovative patient-relevant in vitro and in silico technologies which are key to the development of these products. Such support will ultimately help patients benefit from new therapies as early as possible.
Amendment 239 #
Proposal for a regulation
Recital 26 a (new)
Recital 26 a (new)
(26 a) Pharmaceutical research plays a decisive role in the continuing improvement in public health. Medicinal products, in particular those that are the result of long, costly research will not continue to be developed in the Union unless they are covered by favourable rules that provide for sufficient protection to encourage such research. However, it is hard to establish a direct link between between EU incentives and EU competitiveness because while the incentives make the EU markets more attractive, they are agnostic to the medicines’ geographical origin and authorised medicines from third countries are equally eligible to all EU incentives, as EU based innovative companies can equally benefit from incentives elsewhere.
Amendment 242 #
Proposal for a regulation
Recital 30
Recital 30
(30) The Agency should be empowered to give scientific recommendations on whether a product under development, which could potentially fall under the mandatory scope of the centralised procedure, meets the scientific criteria to be a medicinal product. Such an advisory mechanism would address, as early as possible, questions related to borderline cases with other areas such as substances of human origin, cosmetics or medical devices, which may arise as science develops. To ensure that recommendations given by the Agency take into account the views of equivalent advisory mechanisms in other legal frameworks, the Agency should consult the relevant advisory or regulatory bodies. Where there is a doubt about the regulatory status of a particular product under development, which could potentially fall under the mandatory scope of the centralised procedure, meets the scientific criteria to be a medicinal product, the Agency and the relevant advisory bodies responsible for other regulatory frameworks, namely medical devices and substances of human origin should engage in consultations. In such cases, the compendium referred to in Regulation (EU) No [reference to be added after adoption cf. COM(2022)338 final] should be consulted. If after consulting the compendium, there remains doubt about the regulatory status the relevant bodies should further consult to determine the regulatory status. The Commission should facilitate the cooperation between the Agency and advisory bodies established by other Union legislation. Where an agreement by consensus cannot be reached by the Agency and the relevant advisory bodies, the Commission should be empowered to take a decision on the regulatory status of the product in question. The opinions and inclusions of the Agency and the relevant advisory bodies on the regulatory status of the product should be made publicly available after the consultations have taken place.
Amendment 253 #
Proposal for a regulation
Recital 34
Recital 34
(34) The simplification of procedures should not have an impact on standards or the quality of scientific evaluation of the medicinal products to guarantee the quality, safety and efficacy of medicinal products. It should also allow for the reduction of the scientific evaluation period from 210 days to 180 days, excluding clock-stops.
Amendment 268 #
Proposal for a regulation
Recital 39
Recital 39
(39) To allow for a more informative decision making and for exchange of information and pooling of knowledge on general issues of scientific or technical nature related to the tasks of the Agency regarding medicinal products for human use, in particular to scientific guidelines on unmet medical needs and the design of clinical trials, or other studies and the generation of evidence along the life cycle of medicinal product, the Agency should be able to have recourse to a consultation process of authorities or bodies active along the life cycle of medicinal products. Additionally, to improve regulatory certainty and cross-sectoral cooperation the Commission should on an annual basis, or more frequently where deemed necessary, organise joint meetings with the advisory bodies established in other Union legislation to assess emerging trends and questions on regulatory status of products and find agreement on common regulatory status principles. These authorities could be, as appropriate, representatives from Heads of Medicines Agencies, the Clinical Trial Coordination and Advisory Group, the SoHO Coordination Board, the Coordination Group on Health Technology Assessment, Medical Devices Coordination Group, medical devices national competent authorities, national competent authorities for pricing and reimbursement of medicines, national insurance funds or healthcare payers. The Agency should also be able to extend the consultation mechanism to consumers, patients, healthcare professionals, industry, associations representing payers, or other stakeholders, as relevant.
Amendment 277 #
Proposal for a regulation
Recital 43 a (new)
Recital 43 a (new)
(43 a) The Union is required, pursuant to Article 208 of the Treaty on the Functioning of the European Union, to take account of development objectives in policies that are likely to have an impact on low- and middle-income countries. Pharmaceutical law has a role to play in the realisation of global public health objectives by promoting the development of efficacious, safe, accessible, and affordable innovations for antimicrobial resistance, poverty-related and neglected diseases, and other conditions of global public health interest and it should continue to ensure the highest standards in exported health products and contribute to stronger and more harmonised international technical requirements applicable to medicinal products. The Commission should consider to explore novel mechanisms to encourage research, development and innovation in areas of major global health interest, such as poverty-related, emerging and re-emerging, and neglected infectious diseases; chronic diseases; or comorbidities, in line with its international commitments and within the limits of its competences.
Amendment 278 #
(43 b) The Commission is empowered to explore novel mechanisms to encourage research, development and innovation in areas of major global health interest, such as poverty-related, emerging and re- emerging, and neglected infectious diseases; chronic diseases; or comorbidities, in line with its international commitments and within the limits of its competences.
Amendment 284 #
Proposal for a regulation
Recital 46
Recital 46
(46) Directive 2010/63/EU of the European Parliament and of the Council on the protection of animals used for scientific purposes49 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 live 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 optimised in order to provide the most satisfactory results whilst using the minimum number of animals. The procedures of such testing should be undertaken as a last resort and be designed to avoid causing pain, suffering, distress or lasting harm to animals and should follow the available Agency and the International Committee for Harmonisation (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 of 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. _________________ 49 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 286 #
Proposal for a regulation
Recital 47
Recital 47
(47) 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 307 #
Proposal for a regulation
Recital 65
Recital 65
(65) In the preparation of scientific advice and in duly justified cases, the Agency should also be able to consult authorities established in other relevant Union legal acts or other public bodies established in the Union, as applicable. These may include experts in clinical trials, medical devices, substances of human origin or any other as required for the provision of the scientific advice in question.
Amendment 327 #
Proposal for a regulation
Recital 77
Recital 77
(77) The development of antimicrobial resistance is a growing concern and the pipeline of effective antimicrobials is obstructed due to a market failure whereby pharmaceutical companies neglect investment in research and development (R&D) concerning novel antibiotics due to profitability considerations; it is therefore necessary to consider new measures to promote the development of priority antimicrobials that are effective against antimicrobial resistance and to support undertakings, often SMEs, which choose to invest in this area. It is equally necessary to support research and development with an aim to develop alternative treatments such as bacteriophages, that are effective against multi-drug resistant bacteria and can be used as alternative or together with antibiotics.
Amendment 336 #
Proposal for a regulation
Recital 78 a (new)
Recital 78 a (new)
(78 a) In response to the COVID-19 pandemic, to counteract market failures exacerbated by the public health crisis and to better respond to cross-border health threats, the Commission service HERA was set up under Commission Decision C(2021) 6712. HERA is tasked to strengthen the Union’s ability to prevent, detect and rapidly respond, by ensuring the supply of crisis relevant medical countermeasures, including through their monitoring, procurement and purchase, by activating emergency research and innovation plans, providing emergency funding and financing, and by taking measures concerning the production, availability and supply of such key medical countermeasures.
Amendment 340 #
Proposal for a regulation
Recital 78 b (new)
Recital 78 b (new)
(78 b) However with the increasing awareness and need for transparency and accountability in expenditure on public health measures and the importance of the missions and responsibilities of HERA it is considered appropriate that it is subject to the same level of oversight and scrutiny requirements as other agencies established under Union legislation such as the ECDC and the EMA.
Amendment 342 #
Proposal for a regulation
Recital 78 c (new)
Recital 78 c (new)
Amendment 346 #
Proposal for a regulation
Recital 78 e (new)
Recital 78 e (new)
(78 e) The increasing prevalence and threat of antimicrobial resistance requires action on different fronts in parallel. In addition to the role of the European Medicines Facility, it is necessary to create a Union push and pull incentive scheme to promote and accelerate the development of novel antimicrobials. In this regard, the Commission should create and define a Union push and pull scheme as well as its funding mechanisms. Given the urgency of need for novel antimicrobials, the Commission should therefore have developed and began the implementation of the scheme by one year after the adoption of the Regulation.
Amendment 347 #
Proposal for a regulation
Recital 78 f (new)
Recital 78 f (new)
(78 f) 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.
Amendment 348 #
Proposal for a regulation
Recital 78 g (new)
Recital 78 g (new)
(78 g) Coordination at EU level of medicinal products could offer a strategic frame to enhance security of supply of needed critical medicines through public procurement. This could draw on Commission guidance and common criteria for the procurement of critical medicines, such as green production and prioritisation of supplies in Europe at times of critical shortages. Such procurement efforts should also 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.
Amendment 465 #
Proposal for a regulation
Recital 135 a (new)
Recital 135 a (new)
(135 a)The EU market for medicines remains fragmented, despite the EU having a single market and being the second largest market for pharmaceuticals in the world. The organisation of healthcare systems is a national competence of Member States: this allows decisions closer to the patient, but also brings major divergences in both pricing and patient access. Better and closer coordination between national authorities opens the door to a more efficient and effective supply of medicines throughout the EU. The reform of the EU pharmaceutical legislation is essential to take the work on critical shortages and security of supply forward, building a pharmaceutical ecosystem that is competitive, future-proof and with a single market in medicines benefitting all Europeans. Furthermore, its goal are to prevent or mitigate critical shortages at EU level and to assure a particular focus on the critical medicines for which security of supply needs to be assured in the EU at all times, in normal times, and in times of crisis.
Amendment 466 #
Proposal for a regulation
Recital 135 b (new)
Recital 135 b (new)
(135 b)More often, Member States experienced critical shortages of certain antibiotics, endangering the health of patients and risking the development of antimicrobial resistance. These critical shortages were the result of changing infection patterns, which strongly increased demand. On the supply side, the long lead times needed to boost production made it difficult to respond quickly. This experience underlined the need for a dedicated effort – from the industry, as well as from Member States and the EU level to address the issue of critical shortages.
Amendment 474 #
Proposal for a regulation
Recital 137
Recital 137
(137) To achieve a better security of supply for medicinal products in the internal market and to contribute thereby to a high level of public health protection, it is appropriate to approximate the rules on monitoring and reporting of actual or potential shortages of medicinal products, including the procedures and the respective roles and obligations of concerned entities in this Regulation. It is important to ensure continued supply of medicinal products, which is often taken for granted across Europe. This is especially true for the most critical medicinal products which are essential to ensure the continuity of care, the provision of quality healthcare and guarantee a high level of public health protection in Europe. To counter certain shortages, medicinal products prepared for individual patients in a pharmacy according to a medical prescription “magistral formula”, or according to the pharmacopoeia and intended to be supplied directly to patients served by the pharmacy “officinal formula”, may be used. Member States should be able to introduce or maintain more robust measures to achieve security of supply for medicines than the safeguards provided for in this Regulation.
Amendment 534 #
Proposal for a regulation
Article 2 – paragraph 2 – point 7 a (new)
Article 2 – paragraph 2 – point 7 a (new)
(7 a) ‘adverse reaction’ means an effect on a person in response to a medicinal product that is noxious and unintended;
Amendment 540 #
Proposal for a regulation
Article 2 – paragraph 2 – point 10
Article 2 – paragraph 2 – point 10
Amendment 553 #
Proposal for a regulation
Article 2 – paragraph 2 – point 11 a (new)
Article 2 – paragraph 2 – point 11 a (new)
(11 a) ‘demand’ means the request for a medicinal product by a healthcare professional or patient in response to clinical need; the demand is satisfactorily met when the medicinal product is acquired in appropriate time and in sufficient quantity to allow continuity of provision of the best care to patients; Wholesalers are usually a key supply link between MAHs and the users of medicines, and in those cases, in order to estimate demand, the quantity requested in wholesale orders should be considered;
Amendment 571 #
Proposal for a regulation
Article 2 – paragraph 2 – point 13
Article 2 – paragraph 2 – point 13
(13) ‘critical shortage in the Member State’ means a shortage of a medicinal product, for which there is no appropriate alternative medicinal producttherapeutical alternative available on the market in that Member State, and that shortage cannot be resolved.
Amendment 573 #
Proposal for a regulation
Article 2 – paragraph 2 – point 14 a (new)
Article 2 – paragraph 2 – point 14 a (new)
(14 a) ‘clock stops’ 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 576 #
Proposal for a regulation
Article 3 – paragraph 2 – point a
Article 3 – paragraph 2 – point a
(a) the applicant shows that the medicinal product constitutes a significant therapeutic, scientific or technical innovation or that the granting of marketing authorisation in accordance with this Regulation is in the interest of patients' health at Union level, including as regards antimicrobial resistance and potential countermeasures such as bacteriophages and medicinal products for public health emergencies;
Amendment 603 #
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1
Article 6 – paragraph 2 – subparagraph 1
For medicinal products, during a public health emergency or to address a major event, that are likely to offer an exceptional therapeutic advancement in the diagnosis, prevention or treatment of a life- threatening, seriously debilitating or serious and chronic condition in the Union, the Agency may, after the Commission has recognised a public health emergency at Union level in accordance with Article 23(1) of Regulation (EU) 2022/2371 and following the advice of the Committee for Medicinal Products for Human Use regarding the maturity of the data related to the development, offer to the applicant a phased review of complete data packages for individual modules of particulars and documentation as referred to in paragraph 1.
Amendment 612 #
Proposal for a regulation
Article 6 – paragraph 6 – subparagraph 1
Article 6 – paragraph 6 – subparagraph 1
The Agency shall ensure that the opinion of the Committee for Medicinal Products for Human Use is given within 180 days, excluding clock stops, after receipt of a valid application. In the case of a medicinal product for human use containing or consisting of genetically modified organisms, the opinion of that Committee shall take into account the evaluation of the environmental risk assessment in accordance with Article 8.
Amendment 641 #
Proposal for a regulation
Article 10 – paragraph 2
Article 10 – paragraph 2
2. Where within 90 days of the validation of the marketing authorisation application and during the assessment the Committee for Medicinal Products for Human Use considers that the submitted data are not of sufficient quality or maturity to complete the assessment, the assessment can be terminated. The Committee for Medicinal Products for Human Use shall summarise the deficiencies in writing. On this basis, the Agency shall inform the applicant accordingly and set a time limit 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 Agency, the application shall be considered as withdrawn by default.
Amendment 737 #
Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 2
Article 20 – paragraph 1 – subparagraph 2
If this obligation would apply to several medicinal products, the Agency shall encourage the marketing authorisation holders concerned to conduct a joint post authorisation environmental risk assessment study, which shall be designed where possible considering non-animal approaches such as in vitro and in silico methods.
Amendment 823 #
Proposal for a regulation
Chapter III a (new)
Chapter III a (new)
III a ADDRESSING PHARMACEUTUCAL MARKET FAILURES IN THE UNION AND FURTHER INCENTIVES FOR THE RESEARCH AND DEVELOPMENT OF PRIORITY ANTIMICROBIALS SECTION 1 TASKS OF THE AGENCY
Amendment 884 #
Proposal for a regulation
Article 40 a (new)
Article 40 a (new)
Article 40a Establishment and legal status of the European Medicines Facility The European Medicines Facility ( ‘EMF’) is hereby established, taking over the tasks and responsibilities of the Health Emergency Preparedness and Response Authority repealing Commission’s decision (2021) 67 and Council Regulation 2021/577. The EMF shall have legal personality. In each of the Member States, the EMF shall enjoy the most extensive legal capacity accorded to legal persons under their laws. It may, in particular, acquire or dispose of movable and immovable property, and be party to legal proceedings. The EMF shall be represented by an Executive Director.
Amendment 893 #
Proposal for a regulation
Article 40 b (new)
Article 40 b (new)
Amendment 894 #
Proposal for a regulation
Article 40 c (new)
Article 40 c (new)
Amendment 895 #
Proposal for a regulation
Article 40 d (new)
Article 40 d (new)
Amendment 896 #
Proposal for a regulation
Article 40 e (new)
Article 40 e (new)
Article 40e Management Board of the EMF 1. The EMF Management Board shall be composed of one representative from each Member State, two representatives of the Commission and two representatives of the European Parliament, all with voting rights. In addition, two representatives of patients' organisations, one representative of doctors' organisations, and one representative of veterinarians' organisations, all without voting rights, shall be appointed by the Council in consultation with the European Parliament on the basis of a list drawn up by the Commission which includes appreciably more names than there are posts to be filled. The list drawn up by the Commission shall be forwarded to the European Parliament, together with the relevant background documents. As quickly as possible, and at the latest within three months of notification, the European Parliament may submit its views for consideration to the Council, which shall then appoint these representatives to the Management Board. The members of the Management Board shall be appointed in such a way as to guarantee the highest levels of specialist qualifications, a broad spectrum of relevant expertise and the broadest possible geographic spread within the European Union. 2. Members of the Management Board and their alternates shall be appointed on the basis of their knowledge, recognised experience and commitment in the field of medical countermeasures, antimicrobial and other unmet medical neds, taking into account relevant managerial, administrative and budgetary expertise. All parties represented in the Management Board shall make efforts to limit turnover of their representatives, in order to ensure continuity of the work of the Management Board. All parties shall aim to achieve a balanced representation between men and women on the Management Board. 3. Each Member State and the Commission shall appoint their members of the EMF Management Board as well as an alternate who will replace the member in their absence and vote on their behalf.
Amendment 897 #
Proposal for a regulation
Article 40 f (new)
Article 40 f (new)
Article 40f EMF Advisory Forum 1. The EMF Advisory Forum (‘Forum’) shall constitute a mechanism for an exchange of information on preparedness and response in the area of medical countermeasures and the pooling of knowledge and expertise. It shall ensure close cooperation between EMF and the competent bodies in the Member States, in particular on the planning and implementation of scientific, health and industrial activities of EMF. 2. The Forum shall be composed of members from technically competent bodies designated by each Member State. Members of the Forum shall not be members of the EMF Board. 3. The Forum shall support the EMF Board in providing scientific and technical advice. 4. The EMF Board may set up sub-groups of the Forum for the purpose of examining specific questions in the fields of science, research or industrial matters. In particular, a subgroup named ‘Joint Industrial Cooperation Forum’ composed of the representatives of the industry and Member States shall be set up. The sub- groups shall report to the Forum. They shall be dissolved as soon as their mandate is fulfilled. 5. The Forum and its sub-groups shall be chaired by a representative of the Commission. It shall meet regularly upon the invitation of the EMF Executive Director and at least four times per year. 6. Representatives of the Commission’s departments may participate in the work of the Forum. 7. The Commission shall provide the secretariat for the Forum. 8. The EMF Executive Director may invite experts or representatives of professional or scientific bodies, or non- governmental organisations with recognised experience in disciplines related to the work of EMF to cooperate in specific tasks and to take part in the relevant activities of the Forum.
Amendment 898 #
Proposal for a regulation
Article 40 g (new)
Article 40 g (new)
Amendment 1042 #
Amendment 1044 #
Proposal for a regulation
Article 61 – paragraph 2 – subparagraph 3
Article 61 – paragraph 2 – subparagraph 3
The Agency shall publish summaries of the recommendations delivered in accordance with paragraph 1, after deletion of all information of a commercially confidential nature. Where an agreement by consensus on the scientific recommendation between the Agency and the advisory or regulatory bodies on the regulatory status of a product cannot be reached, the case shall be referred to the Commission for a decision on the regulatory status. For transparency purposes, the respective opinions and conclusions of the Agency and the relevant advisory bodies on the regulatory status of the product shall be made publicly available after the consultations, and where applicable, joint meetings, have taken place.
Amendment 1047 #
Proposal for a regulation
Article 62 – paragraph 1 – subparagraph 1
Article 62 – paragraph 1 – subparagraph 1
In the case of duly substantiated disagreement with the Agency’sscientific recommendation, in accordance with Article 61(2), a Member State may request the Commission to decide whether the product is a product referred to in Article 61(1).
Amendment 1048 #
Proposal for a regulation
Article 62 – paragraph 2
Article 62 – paragraph 2
2. The Commission may ask the Agency and the relevant advisory or regulatory bodies involved in the delivery of the scientific recommendation for clarifications or refer the recommendation back to the Agency for further consideration where a Member State's substantiated request raises new questions of a scientific or technical nature or on its own initiative.
Amendment 1075 #
Proposal for a regulation
Article 65 – paragraph 2 – point c a (new)
Article 65 – paragraph 2 – point c a (new)
(c a) detailed reason(s) for the transferring of the orphan designation
Amendment 1218 #
Proposal for a regulation
Article 71 – paragraph 6
Article 71 – paragraph 6
6. The market exclusivity of the orphan medicinal product shall not prevent the submission, validation and, assessment or granting of an application for a marketing authorisation for a similar medicinal product, including generics and biosimilars, where the remainder of the duration of the market exclusivity is less than two years.
Amendment 1360 #
Proposal for a regulation
Article 91 – paragraph 3 a (new)
Article 91 – paragraph 3 a (new)
3 a. By way of derogation of Article 91, paragraph 1, marketing authorisation holders of vaccines, any clinical study which involves the use in the paediatric population of a vaccine covered by a marketing authorisation and is sponsored by the marketing authorisation holder, whether or not it is conducted in compliance with an agreed paediatric investigation plan, shall be submitted to the Agency or to the Member States which have previously authorised the medicinal product concerned within twelve months of completion of the studies concerned.
Amendment 1370 #
Proposal for a regulation
Article 101 – paragraph 1 – subparagraph 3
Article 101 – paragraph 1 – subparagraph 3
The Eudravigilance database shall contain information on suspected adverse reactions in human beings arising from use of the medicinal product within the terms of the marketing authorisation as well as from uses outside the terms of the marketing authorisation, including medication errors and on those occurring in the course of post-authorisation studies with the medicinal product or associated with occupational exposure.
Amendment 1373 #
Proposal for a regulation
Article 101 – paragraph 2 – subparagraph 5
Article 101 – paragraph 2 – subparagraph 5
The Agency shall ensure that healthcare professionals and the public have appropriate levels of access to the Eudravigilance database, and that personal data is protected in line with the EU data protection and privacy legislation. The Agency shall work together with all stakeholders, including research institutions, healthcare professionals, and patient and consumer organisations, in order to define the ‘appropriate level of access’ for healthcare professionals and the public to the Eudravigilance database.
Amendment 1374 #
Proposal for a regulation
Article 101 – paragraph 2 – subparagraph 6
Article 101 – paragraph 2 – subparagraph 6
The data held on the Eudravigilance database shall be made publicly available in an aggregated and anonymised format together with an explanation of how to interpret the data. Where anonymization is not possible, the data shall be pseudonymised.
Amendment 1375 #
Proposal for a regulation
Article 101 – paragraph 2 – subparagraph 6 a (new)
Article 101 – paragraph 2 – subparagraph 6 a (new)
The Commission is empowered to adopt an implementing act to further specify the categories of personal data processed in the Eudravigilance database after consulting with and duly integrating the opinion of the European Data Protection Supervisor. The implementing act shall be adopted in accordance with the examination procedure referred to in Article 17.
Amendment 1388 #
Proposal for a regulation
Article 111 – paragraph 1
Article 111 – paragraph 1
The Agency and the Member States shall cooperate to continuously develop pharmacovigilance systems, including those that record adverse events including medication errors, processes and standards for medication safety, and implement digital technologies in healthcare settings, capable of achieving high standards of public health protection for all medicinal products, regardless of the routes of marketing authorisation, including the use of collaborative approaches, to maximise use of resources available within the Union.
Amendment 1394 #
Proposal for a regulation
Article 112 a (new)
Article 112 a (new)
Amendment 1526 #
Proposal for a regulation
Article 120 – paragraph 1
Article 120 – paragraph 1
1. Wholesale distributors and other persons or legal entities that are authorised or entitled to supply medicinal products authorised to be placed on the market of a Member State pursuant to Article 5 of [revised Directive 2001/83/EC] to the public mayshall report a shortage of a given medicinal product marketed in the Member State concerned to the competent authority in that Member State.
Amendment 1550 #
Proposal for a regulation
Article 121 – paragraph 1 – point c a (new)
Article 121 – paragraph 1 – point c a (new)
(c a) request from pharmacies supplying hospitals and hospital pharmacies, to electronically communicate data on available stock of the respective medicinal product, in order to avert or mitigate an imminent or existing supply shortage relevant to the supply of a medicinal product.
Amendment 1642 #
Proposal for a regulation
Article 128 – paragraph 2
Article 128 – paragraph 2
2. The marketing authorisation holder as defined in Article 116(1) authorisation shall be responsible for providing correct, not misleading, and complete information as requested by the competent authority concerned as defined in Article 116(1) and shall have the duty to cooperate and to disclose on their own motion any relevant information without undue delay to that competent authority and to update the information as soon as that information becomes available.