Activities of Tilly METZ related to 2023/0131(COD)
Shadow 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 (194)
Amendment 203 #
Proposal for a regulation
Recital 1 a (new)
Recital 1 a (new)
(1 a) This Regulation contributes to the implementation of the One Health Approach, stressing the well-established interconnectedness between human, animal, and ecosystem health and the need to include those three dimensions when addressing public health threats. The loss of biodiversity, changes in land use, deforestation, urbanisation, agricultural expansion and intensification, poor air quality, wildlife trafficking and consumption patterns and transmissions of diseases between humans and animals are all factors that have contributed to the increasing disease burden. In addition, pollution from active pharmaceutical ingredients negatively affects the quality of waters and ecosystems, posing risks to public health globally.
Amendment 211 #
Proposal for a regulation
Recital 3
Recital 3
(3) Addressing unequal patient access of medicinal products has become a key priority of the Pharmaceutical Strategy for Europe as has been highlighted by the Council and the European Parliament. Member States have called for revised mechanisms and incentives for development of medicinal products tailored to the level of unmet medical need, while ensuring patient access and availabilityconditionalities related to transparency, affodability and availability are in place to ensure patient access of medicinal products in all Member States.
Amendment 213 #
Proposal for a regulation
Recital 4
Recital 4
(4) Previous amendments to the Union pharmaceutical legislation have addressed access to medicinal products by providing for accelerated assessment for 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 in some areas, and there still exist many unaddressed public health priorities, these medicinal products do not always reach the patient and patients in the Union still have different levels of access to medicines, for instance due to their high prices, inadequate infrastructures in Member States or the industry’s business strategy.
Amendment 215 #
Proposal for a regulation
Recital 5
Recital 5
(5) The COVID-19 pandemic has spotlightfurther underlined critical issues which require a reform of the Union pharmaceuticals framework to improve medicines availablity, to strengthen its resilience and to ensure that it corresponds to public health needs and serves the people under all circumstances.
Amendment 220 #
Proposal for a regulation
Recital 6
Recital 6
(6) For the sake of clarity, it isIt is therefore necessary to replace Regulation (EC) No 726/2004 of the European Parliament and of the Council38 with a new Regulation. _________________ 38 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).
Amendment 222 #
Proposal for a regulation
Recital 12
Recital 12
(12) The structure and operation of the various bodies making up the Agency should be designed in such a way as to take into account the need to constantly renew scientific expertise, the need for cooperation between Union and national bodies, the need for adequate involvement of civil society, and the future enlargement of the Union. The various bodies of the Agency should establish and develop appropriate contacts with the parties concerned, in particular with representatives of patients, consumers and healthcare professionals.
Amendment 224 #
Proposal for a regulation
Recital 13
Recital 13
(13) The chief task of the Agency should be to provide Union institutions and Member States with the best possible scientific opinions to enable them to exercise the powers of authorisation and supervision of medicinal products conferred on them by Union legal acts in the field of medicinal products. Marketing authorisation should be granted by the Commission only after a single scientific evaluation procedure addressing the quality, safety and, efficacy of high- technologyand environmetal risk of medicinal products has been conducted by the Agency, applying the highest possible standards.
Amendment 225 #
Proposal for a regulation
Recital 15
Recital 15
(15) The Agency's budget should be transparent composed of fees and charges paid by the private sector and contributions from the Union budget to implement Union policies and contributions paid from third countries. Although the majority of its funding comes from fees, the Agency is a public authority and it is of utmost importance to safeguard its integrity and independence in order to ensure public trust in the Union regulatory framework.
Amendment 226 #
Proposal for a regulation
Recital 18 a (new)
Recital 18 a (new)
Amendment 228 #
Proposal for a regulation
Recital 19
Recital 19
(19) Scientific advice for future applicants seeking a marketing authorisation should be provided more generally and in greater depth. Similarly, structures allowing the development of advice for companies, in particular small and medium-sized enterprises (‘SMEs’), and non-for-profit entities should be put in place.
Amendment 233 #
(20 a) Despite the evolution of science and technology at a rapid pace and the regulatory incentives currently in place, there are many diseases without or only with suboptimal treatments. This Regulation should contribute to the development of treatments to tackle these unmet medical needs. These are in particular life threatening or severely debilitating diseases where no treatment alternative exists or where the disease still causes high morbidity or mortality, despite available therapeutic options. Products receiving regulatory incentives should result in a meaningful reduction in disease morbidity or mortality for the relevant patient population and a significant increase in patient’s quality of life.
Amendment 237 #
Proposal for a regulation
Recital 21 a (new)
Recital 21 a (new)
(21 a) Based on the Ombudsman’s decision in the strategic inquiry on how the European Medicines Agency engages with medicine developers in the period leading up to applications for authorisations to market new medicines in the EU1a, the Agency should enhance transparency of scientific advice. In addition, staff and experts from national competent authorities providing scientific advice should not be involved in a subsequent evaluation of marketing authorisation application for the same products. _________________ 1a European Ombudsman’s Decision in strategic inquiry OI/7/2017/KR on how the European Medicines Agency engages with medicine developers in the period leading up to applications for authorizations to market new medicines in the EU, July 2019.
Amendment 240 #
Proposal for a regulation
Recital 29
Recital 29
(29) Legal entities that are not engaged in an economic activity such as universities, public bodies, research centres or not-for-profit organisations, represent an important source of research in unmet medical needs, research in different subpopulations, repurposing, optimisation and innovation and should also benefit from this support scheme. Whereas it should be possible to take account of the particular situation of these entities on an individual basis, such support can best be achieved by means of a dedicated support scheme, including administrative support and through the reduction, deferral and waiver of fees.
Amendment 246 #
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 opinions differ between the Agency and other advisory bodies, the diverging opinions and their reasoning shall be included in the recommendations of the Agency.
Amendment 250 #
Proposal for a regulation
Recital 31
Recital 31
(31) The Agency has an important role in sharing of information with the general public in order to ensure trust in its work and to support health literacy of patient and consumers. In addition, it is key to share up to date information with healthcare professionals, including pharmacists, and the scientific community. To increase transparency of scientific assessments and all other activities, a user-friendly European medicines web- portal should be created and maintained by the Agency. The portal should serve an information hub for all centrally authorised medicinal products and include information about safety, efficacy, environmental risk, patient populations, antimicrobial resistance, shortages, pending obligations for marketing authorisation holders and status on intellectual property, regulatory and market protection periods. Sufficient budget should be allocated to the Agency to ensure appropriate implementation of its transparency obligations and commitments.
Amendment 256 #
Proposal for a regulation
Recital 35
Recital 35
(35) The Agency’s scientific committees should be able to delegate some ofsupported for their evaluation duties toby working parties which should be open to experts from the scientific world and appointed for this purpose, and by additional experts drawn from the pool of accredited experts, whilst retaining complete responsibility for the scientific opinions issued by them.
Amendment 258 #
Proposal for a regulation
Recital 36
Recital 36
(36) The expertise of the Committee for Advanced Therapies (CAT), the Committee for Orphan Medicinal Products (COMP), the Paediatric Committee (PDCO) and Committee for Herbal Medicinal Products (HMPC) is retained through working groups, working parties and a pool of experts who are organised based on different domains and who are giving input to the CHMP and PRAC. Their evaluation will continue to encompass all the necessary expertise for each product as part of the rapporteur teams, with the possibility for CHMP and PRAC to call upon additional scientific experts to provide specific input and advice on specific aspects raised during the evaluation. In addition, patients and healthcare professionals will be part of the pool of experts and will also be brought into EMA’s work according to their expertise in a certain disease area. The CHMP and PRAC consists of experts from all Member States while working parties and expert groups consist in majority of experts appointed by the Member States, based on their expertise, and of external experts. The model of rapporteurs remains unchanged. Representation of patients and health care professionals, with expertise in all areas, including rare and paediatric diseases, is increased at the CHMP and PRAC, in addition to the dedicated working groups representing patients and health care professionals.
Amendment 266 #
Proposal for a regulation
Recital 37 a (new)
Recital 37 a (new)
(37 a) To ensure the adequate expertise and evaluation of the environmental risk assessments of pharmaceutical substances, the Agency establishes a new Environmental Risk Assessment working party which will have the scientific knowledge to characterise and assess the risks and hazards related to the development, production, use and disposal of medicines and their impact on the environment, animals, humans and public health. The working party will ensure the One Health Approach in medicines evaluation and closing the gap between pharmaceutical and environmental assessment. The working party ensures, based on cross-sectorial scientific knowledge, that substance is adequately assessed and the risk minimisation and containment strategies proposed by the applicants are sufficient in order to place the product on the market.
Amendment 275 #
Proposal for a regulation
Recital 41 a (new)
Recital 41 a (new)
(41 a) Protecting global health is one of the priorities of the EU and under Article 178 of the Treaty, the Union should take into account the development policy aspects in any measure and promote the creation of conditions fit for human beings worldwide. To this end, this Regulation should particularly allow for the development of efficacious, safe, accessible, and affordable innovations to address global public health needs, including antimicrobial resistance, poverty-related and neglected diseases, widespread tropical disease and ensure high quality standards for medicinal products that are exported.
Amendment 279 #
Proposal for a regulation
Recital 44
Recital 44
(44) The quality, safety and, efficacy and environmental risk criteria of [revised Directive 2001/83/EC] should apply to medicinal products authorised by the Union under the centralised procedure. The benefit-risk balance of all medicinal products will be assessed when they are placed on the market, five years after approval and at any other time the competent authority deems appropriate.
Amendment 281 #
Proposal for a regulation
Recital 45
Recital 45
(45) Marketing authorisation applications, like any other application submitted to the Agency, should follow the digital by default principle and hence be sent to the Agency in electronic form. Applications should be assessed based on the file submitted by the applicant in accordance with the different legal basis provided by [revised Directive 2001/83/EC]. At the same time, the Agency and the relevant committees may take into account any information that is in its possession. Applicants shall be requested to generally submit raw data, in particular with regard to the clinical trials performed by the applicant in order to ensure a full assessment of the quality, safety and, efficacy and environmental risk of the medicinal product.
Amendment 282 #
Proposal for a regulation
Recital 45 a (new)
Recital 45 a (new)
(45 a) Particular attention should be given to the gender balance of clinical trials so that women can fully and safely benefit from medicines throughout their life-course.
Amendment 283 #
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. Ultimately, efforts should be made to fully replace procedures on live animals for scientific purposes. 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 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 (NAMs) 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 grouping 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), aquatic egg models as well as invertebrate species.
Amendment 288 #
Proposal for a regulation
Recital 49
Recital 49
Amendment 291 #
Proposal for a regulation
Recital 51
Recital 51
(51) As a general rule a marketing authorisation should be granted for an unlimited time; however,for products other than generics should be granted for a period of five years in order to allow for the integration of real world evidence and re- assessment of the risk-benefit balance and in case of orphan medicines, also the related criteria related to population size and generated profit; once renewal may be decided only on justified grounds related to the safety of the medicinal producted, the marketing authorisation shall be valid for an unlimited period, unless the Agency decides on justified grounds related to the safety of the medicinal product to proceed with an additional five-year renewal period or revocation of the marketing authorisation.
Amendment 293 #
Proposal for a regulation
Recital 51 a (new)
Recital 51 a (new)
(51 a) As a general rule, marketing authorisation should be granted based on comparative clinical trials on patients who are representative of the population to be treated with the product. To this end, placebo controlled trials should only be accepted where duly justified, necessary and ethical. In addition, patient-reported outcome measures (PROMs) and patient- reported experience measures (PREMs) should be an integral part of clinical data submitted with the marketing authorisation application in order to assess the quality of care and the impact of the treatments on patients.
Amendment 298 #
Proposal for a regulation
Recital 54
Recital 54
(54) [revised Directive 2001/83/EC] permits Member States to temporarily allow the use and supply of unauthorised medicinal products for public health reasons or individual patient needs and that includes medicinal products to be authorised under this Regulation. It is also necessary, that Member States are allowed under this Regulation to make a medicinal product available for compassionate use prior to its marketing authorisation. In those exceptional and urgent situations, where there is a lack of a suitable authorised medicinal product, the need to protect public health or the health of individual patients must prevail over other considerations, in particular the need to obtain a marketing authorisation and consequently, to have available complete information about the risks posed by the medicinal product, including any risks to the environment from medicinal products containing or consisting of genetically modified organisms (GMOs). To avoid delays in making these products available or uncertainties as regards their status in certain Member States, it is appropriate, in those exceptional and urgent situations, that for a medicinal product containing or consisting of GMOs, an environmental risk assessment or consent in accordance with Directive 2001/18/EC or Directive 2009/41/EC of the European Parliament and of the Council52 should not be a prerequisite. Nevertheless, in these cases, Member States should implement appropriate measures to minimiseprevent foreseeable negative environmental impacts resulting from the intended or unintended release of the medicinal products containing or consisting of GMOs into the environment and agree on an appropriate timeline for the delivery of the environmental risk data. _________________ 52 Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (Recast) (OJ L 125, 21.5.2009, p. 75).
Amendment 304 #
Proposal for a regulation
Recital 58
Recital 58
(58) There is the possibility under certain duly justified circumstances for marketing authorisations to be granted, subject to specific obligations or conditions, on a conditional basis or under exceptional circumstances. The legislation should allow under similar circumstances for medicinal products with a standard marketing authorisation for new indications to be authorised on a conditional basis or under exceptional circumstances. The medicinal products authorised on a conditional basis or under exceptional circumstances should in principle satisfy the requirements for a standard marketing authorisation with the exception of the specific derogations or conditions outlined in the relevant conditional or exceptional marketing authorisation and shall be subject to specific review of the fulfilment of the imposed specific conditions or obligations. It is also understood that the grounds for refusal of a marketing authorisation shall apply mutatis mutandis for such cases.
Amendment 308 #
Proposal for a regulation
Recital 65
Recital 65
(65) In the preparation of scientific advice and in duly justified cases, the Agency should alsopromote an open discussion about latest scientific developments and the update of scientific guidelines and should 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 311 #
Proposal for a regulation
Recital 67
Recital 67
(67) The Agency, in consultation with the Member States and the Commission, should set the scientific selection criteria for medicinal products that receive pre- authorisation support with priority to be given to public health need and the most promising developments in therapies. In the case of medicinal products for unmet medical needs, based on the scientific selection criteria set by the Agency, any interested developer can submit preliminary evidence to demonstrate that the medicinal product has the potential to provide a major therapeutic advancement with respect to the identified unmet medical need.
Amendment 323 #
Proposal for a regulation
Recital 76
Recital 76
(76) It is considered appropriate to also have the possibility for the Commission to grant temporary emergency marketing authorisations to address public health emergencies. Temporary emergency marketing authorisations may be granted provided that, having regard to the circumstances of the public health emergency, the benefit of the immediate availability on the market of the medicinal product concerned outweighs the risk inherent to the fact that additional comprehensive quality, non-clinical, clinical data may still be required. The decision of the Commission should be based on the opinion issued by the Agency, detailing how the medicinal product could be effective in treating, preventing or diagnosing the disease or condition directly related to the public health emergency and how the benefits of using the product outweigh the risks. In that effect, and given the limited knowledge of both the benefits and risks, the Agency should only take into account plausible expectations of benefits which should be grounded on the data available at the time of the opinion. A temporary emergency marketing authorisation should be valid only during the public health emergency. The Commission should be given the possibility to vary, suspend or revoke such marketing authorisations in order to protect public health or when the marketing authorisation holder has not complied with the conditions and obligations set out in the temporary emergency marketing authorisation.
Amendment 331 #
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; 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 and non-for-profit entities, which choose to invest in this area.
Amendment 332 #
Proposal for a regulation
Recital 78
Recital 78
(78) To be considered a ‘priority antimicrobial’, a medicinal product should represent a real advancement against antimicrobial resistance and should therefore bring forward non-clinical and clinical data that underpin a significant clinical benefit with respect to antimicrobial resistance. When assessing the conditions for antibiotics, the Agency shall take into account the prioritisation of pathogens as regards the risk of antimicrobial resistance provided for in the ‘WHO priority pathogens list for R&D of new antibiotics’, specifically those listed as priority 1 (critical) or priority 2 (high) or in case there is an equivalent list of priority pathogens adopted at Union level, the Agency should take such Union list into account as a priority. In order to address market failures for the development of antimicrobials, the priority focus should be on the research and development and subsequent production and fair distribution of new antimicrobials. However, addressing AMR will not be solved by R&D alone. To ensure prudent use of existing antibiotics, the Authority should also support the development and procurement of rapid diagnostic tools to ensure appropriate prescriptions.
Amendment 333 #
Proposal for a regulation
Recital 78 a (new)
Recital 78 a (new)
(78 a) To seriously tackle major ongoing public health challenges, the antimicrobial resistance in particular, while also building on existing resources, the Health Emergency Preparedness and Response Authority (HERA) should be established as a separate structure under the legal personality of the European Centre for Disease Prevention and Control (ECDC) to boost EU’s capability to address health emergencies. The Authority should be responsible for creating, coordinating and implementing the long-term European portfolio of biomedical research and development agenda for medical countermeasures against current and emerging public health threats, as well as providing tools to ensure EU-wide access to these products, including those to support production, procurement, stockpiling and distribution capacity of medical countermeasures and other priority medical products in the EU. The Authority will play a crucial role in addressing health threats globally. The Authority should primarily focus on the fight against antimicrobial resistance and the development of new antimicrobials and medical countermeasures linked to public health emergencies. However, in the future with increasing capacity, the Authority should expand the scope of its agenda, specifically to tackle other areas of unmet medical need such as rare and neglected diseases. The Authority should have adequate resources to fulfil its mandate.
Amendment 338 #
Proposal for a regulation
Recital 78 b (new)
Recital 78 b (new)
Amendment 343 #
Proposal for a regulation
Recital 78 c (new)
Recital 78 c (new)
(78 c) The principle of open science is pivotal to ensure rapid progress in the field of scientific research for priority antimicrobials. Over the past 30 years, the lack of sharing of results, failed trials and ongoing research has created bottlenecks for scientific development and contributes to the current market failure for the placing on the market of new antimicrobials. It is therefore of the utmost importance to have a paradigm shift towards open science, particularly in the area of publicly-funded research, to reduce duplication of research, allow for peer-verification of results and building further evidence based on most recent findings, as to making research and development funding efforts more efficient. Indeed, it would also allow HERA to avoid funding research projects that would lead to similar mistakes being repeated over and over. Open science should serve as the basis for the coordinated research effort.
Amendment 344 #
Proposal for a regulation
Recital 78 d (new)
Recital 78 d (new)
(78 d) In order to ensure sufficient investment to address AMR, the European Antimicrobial Innovation Fund should be established. The Fund should generate and invest at least 1 billion EUR per year to address antimicrobial resistance. Since the manufacturing, use and disposal of antibiotics and other pharmaceutical substances in humans and animals and their prevalent occurance in the environment is the main cause of AMR and only a handful of developers are actively addressing this emergency, the collective effort, under the One Health Approach, of the industry and public authorities must be in place to solve the crisis. As per the polluter pays principle, companies selling medicines on the EU market, therefore contributing to the growing problem of environmental pollution including antimicrobial resistance, which do not wish to invest in R&D of antimicrobials should financially support, through annual penalty payments, the collective efforts to solving this public health emergency to the European Antimicrobial Innovation Fund. Other EU funding as well as voluntary contributions from philanthropic organisations, international schemes or Member States should represent complementary sources allocated to this Fund.
Amendment 351 #
Proposal for a regulation
Recital 79
Recital 79
Amendment 358 #
Proposal for a regulation
Recital 80
Recital 80
Amendment 365 #
Proposal for a regulation
Recital 81
Recital 81
Amendment 368 #
Proposal for a regulation
Recital 82
Recital 82
Amendment 372 #
Proposal for a regulation
Recital 83
Recital 83
Amendment 378 #
Proposal for a regulation
Recital 84
Recital 84
Amendment 381 #
Proposal for a regulation
Recital 86
Recital 86
(86) Medicinal products for rare diseases and for children should be subject to the same provisions as any other medicinal product concerning their quality, safety, and efficacy and environmental risk, for example for what concerns the marketing authorisation procedures, the pharmacovigilance and quality requirements. However, specific requirements also apply to them. Such requirements, which are currently defined in separate legislations, should be integrated in this Regulation in order to ensure clarity and coherency of all the measures applicable to these medicinal products.
Amendment 382 #
Proposal for a regulation
Recital 87
Recital 87
(87) Some orphan conditions occur so infrequently that the cost of developing and bringing to the market a medicinal product to diagnose, prevent or treat the condition cannot be recovered by the expected sales of the medicinal product. However, patients suffering from rare conditions should be entitled to the same quality of treatment as other patients; it is therefore necessary to stimulate the research, development and placing on the market of appropriate medications by the pharmaceutical industry.
Amendment 391 #
Proposal for a regulation
Recital 88
Recital 88
(88) Regulation (EC) No 141/2000 of the European Parliament and of the Council55 has proved to be successful in boosting developments of orphan medicinal products in the Union; for certain conditions; nevertheless, 95% of rare diseases are still without authorised treatment and the treatments available for the 5% are not necessarily transformative or curative1a, therefore an action at Union level remains preferable to uncoordinated measures by the Member States which may result in distortions of competition and barriers to intra-Union trade. _________________ 1a https://research-and- innovation.ec.europa.eu/system/files/2022 -02/ec_rtd_he-partnerships-rare- diseases.pdf 55 Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ L 18, 22.1.2000, p. 1).
Amendment 392 #
Proposal for a regulation
Recital 90
Recital 90
(90) Objective criteria for the orphan designation based on the prevalence of the life-threatening or chronically debilitating condition for which diagnosis, prevention or treatment is sought and the existence of no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorised in the Union should be maintained; a prevalence of not more than five affected persons per 10 000 is generally regarded as the appropriate threshold. The orphan designation criterion on the basis of return on investment has been abolished, since it has never been used. nevertheless, products may still lose the orphan status in cases where the population criterion is no longer met or when sufficient profit was generated after five years on the market.
Amendment 393 #
Proposal for a regulation
Recital 90 a (new)
Recital 90 a (new)
(90 a) The aim of intellectual property and regulatory incentives is to benefit society and promote innovation in areas of public health and unmet medical needs, such as rare diseases. It is of utmost importance that such incentives are not misused or abused, nor pose threats to affordability and patient access to treatments. In particular, the practice of artificially subdividing diseases to create subgroups of patients in order to fall under the orphan medicine prevalence criterion should be prohibited.
Amendment 394 #
Proposal for a regulation
Recital 91
Recital 91
Amendment 396 #
Proposal for a regulation
Recital 92
Recital 92
Amendment 408 #
Proposal for a regulation
Recital 93
Recital 93
(93) If a satisfactory method of diagnosis, prevention or treatment of the condition in question has already been authorised in the Union, the orphan medicinal product will have to be of significant benefit to those affected by that condition. In this context, a medicinal product authorised in one Member State is generally deemed as being authorised in the Union. It is not necessary for it to have Union authorisation or to be authorised in all Member States to be considered as a satisfactory method. In addition, commonly used methods of diagnosis, prevention or treatment that are not subject to a marketing authorisation may be considered satisfactory if there is scientific evidence of their efficacy and safety. In certain cases, medicinal products prepared for an individual patient in a pharmacy according to a medical prescription, or according to the prescriptions of a pharmacopoeia and intended to be supplied directly to patients served by the pharmacy, mayshould also be considered as satisfactory treatment if they are well known and safe and this is a general practice for the relevant patient population in the Union.
Amendment 412 #
Proposal for a regulation
Recital 99
Recital 99
(99) A vast percentage of rare diseases remains without treatment with research and development clustered in the areas where profit is better assured. Therefore, there is a need to target those areas where research is mostly needed and where investments are most riskylacking.
Amendment 414 #
Proposal for a regulation
Recital 100
Recital 100
(100) Orphan medicinal products addressing a high unmet medical need prevent, diagnose or treat conditions where either no other method of prevention, diagnosis or treatment exists or, if such method already exists, they would bring exceptional therapeutic advancement. In both cases, the criterion of meaningfusubstantial reduction in disease morbidity or mortality for the relevant patient population should ensure that only most effective medicinal products are covered. The Agency should draw up scientific guidelines on the category of ‘orphan medicinal products addressing a high unmet medical need’.
Amendment 418 #
Proposal for a regulation
Recital 102
Recital 102
(102) In order to incentivise research and development of orphan medicinal products addressing high unmet needs, to ensure market predictability and to ensure a fair distribution of incentives, a modulation of market exclusivity has been introduced; orphan medicinal products addressing high unmet medical needs benefit from the longest market exclusivity, while market exclusivity for well-established use orphan medicinal products, requiring less investment, is the shortest. In order to ensure increased predictability for developers, the possibility to review the eligibility criteria for market exclusivity after six years after the marketing authorisation has been abolished.
Amendment 422 #
Proposal for a regulation
Recital 103
Recital 103
(103) In order to encourage faster and wider access also to orphan medicinal products, an additional period of one yearsix months of market exclusivity is granted to orphan medicinal products for a Union market launch, with the exception of well- established use medicinal products.
Amendment 427 #
Proposal for a regulation
Recital 104
Recital 104
Amendment 441 #
Proposal for a regulation
Recital 132
Recital 132
(132) The Union and Member States have developed a scientific evidence-based process that allows competent authorities to determine the relative effectiveness of new or existing medicinal products. This process focuses specifically on the added value of a medicinal product in comparison with other new or existing health technologies However, this evaluation should not be conducted in the context of the marketing authorisation, for which it is agreed that the fundamental criteria should be retained. It is useful in this respect to allow for the possibility of gathering information on the methods used by the Member States to determine the therapeutic benefit obtained by each new medicinal product. To ensure that medicine developers generate the right type of data for regulators throughout the market access pathway, the marketing authorisation applicants should submit, unless where duly justified and ethical, data from active-control clinical trials. This is important to avoid the unnecessary repetition of clinical studies, and to uphold high scientific standards and ethical principles at the point of marketing authorisation.
Amendment 448 #
Proposal for a regulation
Recital 133
Recital 133
Amendment 456 #
Proposal for a regulation
Recital 134
Recital 134
Amendment 462 #
Proposal for a regulation
Recital 135
Recital 135
Amendment 481 #
Proposal for a regulation
Recital 138
Recital 138
(138) The national competent authorities should be empowered to monitor shortages of medicinal products that are authorised through both national and centralised procedures, based on notifications of marketing authorisation holders. The Agency should be empowered to monitor shortages of medicinal products that are authorised through the centralised procedure, also based on notifications of marketing authorisation holders. When critical shortages are identified, both national competent authorities and the Agency should work in a coordinated manner to communicate the necessary information to patients, consumers and healthcare professionals, including on estimated duration and available alternatives, and manage those critical shortages, whether the medicinal product concerned by the critical shortage is covered by a centralised marketing authorisation or a national marketing authorisation and register such information in the European Shortages Monitoring Platform. Marketing authorisation holders and other relevant entities must provide the relevant information to inform the monitoring. Wholesale distributors and other persons or legal entities, including patientimporters, manufacturers, suppliers, patient and consumer organisations or health care professionals, may also report a shortage of a given medicinal product marketed in the Member State concerned to the competent authority. The Executive Steering Group on Shortages and Safety of Medicinal Products (‘the Medicines Shortages Steering Group’ (MSSG)) already established within the Agency pursuant to Regulation (EU) 2022/123 of the European Parliament and of the Council56 , should adopt a list of critical shortages of medicinal products and ensure monitoring of those shortages by the Agency. The MSSG should also adopt a list of critical medicinal products authorised in accordance with [revised Directive 2001/83/EC] or this Regulation to ensure monitoring of the supply of those products. The MSSG may provide recommendations on measures to be taken by marketing authorisation holders, the Member States, the Commission and other entities to resolve any critical shortage or to ensure the security of supply of those critical medicinal products to the market. Implementing acts can be adopted by the Commission to ensure that appropriate measures, including the establishment or maintenance of contingency stocks, are taken by marketing authorisation holders, wholesale distributors or other relevant entities. _________________ 56 Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (OJ L 20, 31.1.2022, p. 1).
Amendment 487 #
Proposal for a regulation
Recital 138 a (new)
Recital 138 a (new)
(138 a)To facilitate appropriate communication between patients and consumers, on the one hand, and competent authorities on the other, Member States should collect data on the impact of shortages of medicinal products on patients and consumers, and share relevant information through the MSSG, in order to inform approaches to management of shortages of medicinal products. Marketing authorisation holders should set up and maintain a minimum safety stock of critical medicinal products which shall be sufficient to cover two months demand of all Member States where the product has been placed on the market. Delegated acts can be adopted by the Commission to ensure that appropriate measures, including the establishment or maintenance of contingency stocks, are taken by marketing authorisation holders, wholesale distributors or other relevant entities. The setting up of safety stocks of critical medicinal products should not hamper the availability and affordability of these products or harm the environment by inappropriate disposals at both European and global level. Given the global nature of pharmaceutical supply chains, the safety stocks should be proportionate and take into account the potential impacts on shortages in other Member States and third countries. In order to avoid any interruption of access to critical medicinal products, national competent authorities may, in duly justified cases, grant an exemption from stockpiling obligations to the marketing authorisation holder, upon request, or adopt other complementary measures on the safety of stocks
Amendment 500 #
Proposal for a regulation
Recital 140
Recital 140
(140) It is recognised that improved access to information contributes to public awareness, gives the public the opportunity to express its observations and enables authorities to take due account of those observations. The general public should therefore have access to information in the Union Register of medicinal products, the Eudravigilance database and the manufacturing and wholesale distribution database, after the deletion of any commercially confidential information by the competent authority and have full access to the data on environmental risks. Regulation (EC) No 1049/2001 of the European Parliament and of the Council57 gives the fullest possible effect to the right of public access to documents and lays down the general principles and limits on such access. The Agency should therefore give the widest possible access to the documents while carefully balancing the right for information with existing data protection requirements. Certain public and private interests, such as personal data and commercially confidential information, should be protected by way of exception in accordance with Regulation (EC) No 1049/2001. _________________ 57 Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).
Amendment 501 #
Proposal for a regulation
Recital 141
Recital 141
(141) To ensure the enforcement of certain obligations relating to the marketing authorisation for medicinal products for human use granted in accordance with this Regulation, the Commission should be able to impose financial penalties. When assessing the responsibility for failures to comply with those obligations and imposing such penalties, it is important that means exist to address the fact that marketing authorisation holders could be part of a wider economic entity. Otherwise, there is a clear and identifiable risk that the responsibility for a failure to comply with those obligations could be evaded, which might have an impact on the ability to impose effective, proportional and dissuasive penalties. The penalties imposed should be effective, proportionate and dissuasive, having regard to the circumstances of the specific case. For the purposes of ensuring legal certainty in the conduct of the infringement procedure, it is necessary to set maximum amounts for penalties. Those maximum amounts should not be linked to the turnover of a particular medicinal producthe non-compliance of an entity with any requirements or obligations under this Regulation, including the supply of incorrect, incomplete or misleading information to competent authorities, should be subject to penalties of up to 20 000 000 EUR, or in the case of an undertaking, up to 5% of its total worldwide annual turnover for the preceding financial year, whichever is higher. In case of ongoing non- compliance, the competent baut the economic entity involvedhority should be able to fine the entity with fines for each day of delay, which shall be transparent and proportionate.
Amendment 504 #
Proposal for a regulation
Recital 143
Recital 143
(143) To ensure uniform conditions for the implementation of this Regulation in relation to marketing authorisations for medicinal products for human use, implementing powers should be conferred on the Commission. The implementing powers related to the granting of centralised marketing authorisations and for suspending, revoking or withdrawing those authorisations, for granting vouchers, establishing and modifying regulatory sandboxes and decisions on the regulatory status of medicinal products should be exercised in accordance with Regulation (EU) 182/2011.
Amendment 511 #
Proposal for a regulation
Recital 149
Recital 149
(149) It is therefore appropriate to envisage a centralised assessment of the ERA involving experts from the national competent authorities and the Environmental Risk Assessment working party.
Amendment 514 #
Proposal for a regulation
Recital 155
Recital 155
(155) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union and notably human dignity, the integrity of the person, the rights of the child, respect for private and family life, the protection of personal data and the freedom of art and science. Similarly, this Regulation respects the Aarhus Convention which protects every person’s right to live in a healthy environment.
Amendment 518 #
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
This Regulation lays down Union procedures for the authorisation, supervision and pharmacovigilance of medicinal products for human use at Union level, establishes rules and procedures at Union and at Member State level relating to the security of supply of medicinal products and lays down the governance provisions of the European Medicines Agency (‘the Agency’) established by Regulation (EC) No 726/2004 which shall carry out the tasks relating to medicinal products for human use that are laid down in this Regulation, Regulation (EU) No 2019/6, Regulation No 2022/123, Regulation No 536/2014 and other relevant Union legal acts.
Amendment 535 #
Proposal for a regulation
Article 2 – paragraph 2 – point 8 – point a
Article 2 – paragraph 2 – point 8 – point a
(a) greater efficacy than an authorised medicinal orphan medicinal product in a substantial part of the target population, as assessed by effect on a clinically meaningful endpoint in adequate and well controlled clinical trial showing a comparative efficacy claim for two different medicinal product;
Amendment 536 #
Proposal for a regulation
Article 2 – paragraph 2 – point 8 – point b
Article 2 – paragraph 2 – point 8 – point b
(b) greater safety than an authorised medicinal product in a substantial part of the target population based on direct comparative trial;
Amendment 541 #
Proposal for a regulation
Article 2 – paragraph 2 – point 10
Article 2 – paragraph 2 – point 10
Amendment 562 #
Proposal for a regulation
Article 2 – paragraph 2 – point 12
Article 2 – paragraph 2 – point 12
(12) ‘shortage’ means a situation in which the supply of a medicinal product that is authorised and placed on the market in a Member State does not meet the demand for that medicinal product in that Member State, whatever the cause.
Amendment 592 #
Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 2
Article 6 – paragraph 1 – subparagraph 2
The documentation shall include a substantiated declaration to the effect that clinical trials carried out outside the Union meet the ethical requirements of Regulation (EU) No 536/2014. Those particulars and documentation shall take account of the unique, Union nature of the authorisation requested and, otherwise than in exceptional cases relating to the application of the law on trademarks pursuant to Regulation (EU) 2017/1001 of the European Parliament and of the Council66 , shall include the use of a single name for the medicinal product. The use of a single name does not exclude the use of additional qualifiers where necessary to identify different presentations of the medicinal product concerned. _________________ 66 Regulation (EU) 2017/1001 of the European Parliament and of the Council of 14 June 2017 on the European Union trade mark (OJ L 154, 16.6.2017, p. 1).
Amendment 593 #
Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 2 – point 1 (new)
Article 6 – paragraph 1 – subparagraph 2 – point 1 (new)
(1) Applications for market authorisation shall provide evidence from comparative studies with a standard-of- care active comparator, including, but not limited to, randomised controlled trials. In exceptional curcumstances, where such studies cannot be provided for scientifically substantiated reasons, the applicant shall submit such duly justified reasoning to the Agency as part of the application for marketing authorisation. The Agency shall set the scientific guidelines on criteria for proposing a comparator for a clinical trial, taking into account the results of the consultation of the Commission and the authorities or bodies involved in the mechanism of consultation referred to in Article 162 of this Regulation.
Amendment 594 #
Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 2 a (new)
Article 6 – paragraph 1 – subparagraph 2 a (new)
Applications for marketing authorisation shall include patient experience data (PROMs/PREMs) in the marketing application dossier. Where such data cannot be provided, the applicant should provide a justification to the Agency.
Amendment 598 #
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1
Article 6 – paragraph 2 – subparagraph 1
For medicinal products 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 Unions with no authorised alternatives, particularly in the Union during a public health emergency or other major event, the Agency may, 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 609 #
Proposal for a regulation
Article 6 – paragraph 5 – subparagraph 2
Article 6 – paragraph 5 – subparagraph 2
The marketing authorisation applicant shall not carry out animal tests in case scientifically satisfactory New Approach Methodologies (NAMs), particularly non- animal testing methods are available. The Agency shall in its annual report highlight key observations and best practices in the replacement, reduction and refinement of animal testing submitted by applicants.
Amendment 615 #
Proposal for a regulation
Article 6 – paragraph 7 – subparagraph 1
Article 6 – paragraph 7 – subparagraph 1
When an application is submitted for a marketing authorisation in respect of medicinal products for human use which are of major interest from the point of view of public health and in particular from the viewpoint of therapeutic innovationunmet medical need, the applicant may request an accelerated assessment procedure. The same shall apply for products referred to in Article 60. The request shall be duly substantiated.
Amendment 624 #
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
1. Without prejudice to Article 22 of [revised Directive 2001/83/EC], the marketing authorisation application of a medicinal product for human use containing or consisting of genetically modified organisms as defined in Article 2(2) of Directive 2001/18/EC shall be accompanied by an environmental risk assessment identifying and evaluating potential adverse effects of the genetically modified organisms on human health, animals and the environment.
Amendment 630 #
Proposal for a regulation
Article 8 – paragraph 1 – point b
Article 8 – paragraph 1 – point b
(b) identification and characterisation of hazards for the environment, animals and for human and public health;
Amendment 633 #
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2
Article 9 – paragraph 1 – subparagraph 2
The Committee for Medicinal Products for Human Use shall establish an Environmental Risk Assessment Working Party and assess the environmental risk assessment.
Amendment 645 #
Proposal for a regulation
Article 12 – paragraph 4 – point i
Article 12 – paragraph 4 – point i
(i) in case of medicinal products for which there is substantial, on duly justified ground submitted to the Agency, there is uncertainty as to the surrogate endpoint relation to the expected health outcome, where appropriate and relevant for the benefit-risk balance, a post- authorisation obligation to substantiate the clinical benefit;
Amendment 647 #
Proposal for a regulation
Article 12 – paragraph 4 – point i a (new)
Article 12 – paragraph 4 – point i a (new)
(i a) justification in case marketing authorisation was granted where no comparative data with a standard-of-care active comparator were submitted;
Amendment 648 #
Proposal for a regulation
Article 12 – paragraph 4 – point j a (new)
Article 12 – paragraph 4 – point j a (new)
(j a) where appropriate any justified reasoning for granting marketing authorisation pursuant to Article 18, 19 and 30 of this Regulation;
Amendment 649 #
Proposal for a regulation
Article 12 – paragraph 4 – point m
Article 12 – paragraph 4 – point m
(m) where appropriate, to carry out medicinal product- specific validation studies to replace animal-based control methods with non- animal-based control methods.
Amendment 650 #
Proposal for a regulation
Article 12 – paragraph 4 – point m a (new)
Article 12 – paragraph 4 – point m a (new)
(m a) for antimicrobials, the stewardship plan referred to in Article 17 and information materials referred to in Article 69 of [revised Directive 2001/83/EC] as well as any related obligations imposed on the marketing authorisation holder.
Amendment 657 #
Proposal for a regulation
Article 14 – paragraph 1 – subparagraph 1 (new)
Article 14 – paragraph 1 – subparagraph 1 (new)
Amendment 679 #
Proposal for a regulation
Article 16 – paragraph 3 – subparagraph 2 – indent 2
Article 16 – paragraph 3 – subparagraph 2 – indent 2
– a summary of environmental risk assessment studies and their results as submitted by the marketing authorisation holder and the assessment of the environmental risk assessment and the information referred to in Article 22(5) of [revised Directive 2001/83/EC] by the Agency.;
Amendment 680 #
Proposal for a regulation
Article 16 – paragraph 3 – subparagraph 2 – indent 2 a (new)
Article 16 – paragraph 3 – subparagraph 2 – indent 2 a (new)
– for antimicrobials, the stewardship plan referred to in Article 17 and information materials referred to in Article 69 of [revised Directive 2001/83/EC], as well as any related obligations imposed on the marketing authorisation holder.
Amendment 686 #
Proposal for a regulation
Article 17 – paragraph 1
Article 17 – paragraph 1
1. Without prejudice to paragraph 2, a mMarketing authorisation for a medicinal product shall be valid for an unlimited periodfive years.
Amendment 690 #
Proposal for a regulation
Article 17 – paragraph 2 – subparagraph 1
Article 17 – paragraph 2 – subparagraph 1
By way of derogation from paragraph 1, the Commission may decide when granmarketing an authorisation, on the basis of a scientific opinion by the Agency concerning the safety of the medicinal product, to limit the validity of the marketing authorisation to five years for products referred to in Article 9 of [revised Directive 2001/83/EC] shall be valid for an unlimited period.
Amendment 692 #
Proposal for a regulation
Article 17 – paragraph 2 – subparagraph 2
Article 17 – paragraph 2 – subparagraph 2
Where the validity of the marketing authorisation is limited to five years, as laid down in paragraph 1, the marketing authorisation holder shall apply to the Agency for a renewal of the marketing authorisation at least nine months before the marketing authorisation ceases to be valid.
Amendment 694 #
Proposal for a regulation
Article 17 – paragraph 2 – subparagraph 3
Article 17 – paragraph 2 – subparagraph 3
Where a renewal application has been submitted in accordance with the secondfirst subparagraph, the marketing authorisation shall remain valid until a decision is adopted by the Commission in accordance with Article 13.
Amendment 695 #
Proposal for a regulation
Article 17 – paragraph 2 – subparagraph 4
Article 17 – paragraph 2 – subparagraph 4
The marketing authorisation may be renewed on the basis of a re-evaluation by the Agency of the benefit-risk balance. Once renewed, the marketing authorisation shall be valid for an unlimited period unless the Agency decides, on justified grounds, to proceed with one additional five-year renewal.
Amendment 696 #
Proposal for a regulation
Article 17 – paragraph 2 a (new)
Article 17 – paragraph 2 a (new)
2 a. By way of derogation from paragraphs 1 and 2, marketing authorisation for a medicinal product shall be withdrawn if the review of the post-authorisation studies referred to in paragraph 1 of Article 20 result in a negative risk-benefit assessment.
Amendment 697 #
Proposal for a regulation
Article 18 – paragraph 1 – introductory part
Article 18 – paragraph 1 – introductory part
1. In exceptional circumstances where, in an application under Article 6 of [revised Directive 2001/83/EC] for a marketing authorisation of a medicinal product or a new therapeutic indication of an existing marketing authorisation under this Regulation, an applicant is unable to provide comprehensive data on the efficacy and safety, and, where missing, on the environmental risk of the medicinal product under normal conditions of use, the Commission may, by derogation to Article 6, grant an authorisation under Article 13, subject to specific conditions, where the following requirements are met:
Amendment 702 #
Proposal for a regulation
Article 18 – paragraph 2 – subparagraph 2
Article 18 – paragraph 2 – subparagraph 2
This reassessment shall be conducted on the basis of an application by the marketing authorisation holder to maintain the authorised new therapeutic indication or, renew the marketing authorisation under exceptional circumstances or issue a negative marketing authorisation opinion and withdraw the product from the market.
Amendment 704 #
Proposal for a regulation
Article 18 – paragraph 2 a (new)
Article 18 – paragraph 2 a (new)
2 a. Before granting an authorisation pursuant to paragraph 1, the Agency shall publish in the product’s assessment report a justification for granting marketing authorisation under this Article and explain why an authorisation pursuant to Article 19 is deemed unsuitable.
Amendment 711 #
Proposal for a regulation
Article 19 – paragraph 2
Article 19 – paragraph 2
2. Conditional marketing authorisations or a new conditional therapeutic indication referred to in paragraph 1 may be granted only if the benefit-risk balance of the medicinal product is favourable and the applicant is likely to be ablecommits to provide comprehensive data within the agreed time-frame .
Amendment 720 #
Proposal for a regulation
Article 19 – paragraph 3
Article 19 – paragraph 3
3. Conditional marketing authorisations or a new conditional therapeutic indication granted pursuant to this Article shall be subject to specific obligations. Those specific obligations and, where appropriate, the time limit for compliance shall be specified in the conditions to the marketing authorisation. Those specific obligations shall be reviewed annually by the Agency for the first three years after granting the authorisation and every two years thereafter.
Amendment 723 #
4. As part of the specific obligations referred to in paragraph 3, the marketing authorisation holder of a conditional marketing authorisation granted pursuant to this Article shall be required to complete ongoing studies, or to conduct new studies, with a view to confirming that the benefit- risk balance is favourable. Information on concrete commitments, timelines, status and, where applicable, justifications for any delays, for the product-specific obligations shall be made publicly available and easily accessible on EMA’s website.
Amendment 729 #
Proposal for a regulation
Article 19 – paragraph 7 a (new)
Article 19 – paragraph 7 a (new)
Amendment 730 #
Proposal for a regulation
Article 19 – paragraph 8 – point b
Article 19 – paragraph 8 – point b
(b) the procedures and requirements for granting a conditional marketing authorisation, for its renewal, and for adding a new conditional therapeutic indication to an existing marketing authorisation , and for product withdrawal.
Amendment 734 #
Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 1 – point c a (new)
Article 20 – paragraph 1 – subparagraph 1 – point c a (new)
(c a) conducts a post-authorisation treatment optimisation study when the optimal usage of medicinal product was not previously established.
Amendment 738 #
Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 3
Article 20 – paragraph 1 – subparagraph 3
Where the Agency considers that any of the post-authorisations studies referred to in points (a) to (ca) is necessary, it shall inform the marketing authorisation holder thereof in writing, stating the grounds for its assessment and shall include the objectives and timeframe for submission and conduct of the study.
Amendment 739 #
Proposal for a regulation
Article 20 – paragraph 4
Article 20 – paragraph 4
4. Where the opinion of the Agency confirms the need for any of the post- authorisation studies referred to in paragraph 1, points (a) to (ca), to be carried out, the Commission shall vary the marketing authorisation, by means of implementing acts, adopted pursuant to Article 13 to include the obligation as a condition of the marketing authorisation unless the Commission returns the opinion to the Agency for further consideration. For obligations under paragraph 1, points (a) and (b), the marketing authorisation holder shall update the risk management system accordingly.
Amendment 747 #
Proposal for a regulation
Article 24 – paragraph 1 – subparagraph 2 – point f a (new)
Article 24 – paragraph 1 – subparagraph 2 – point f a (new)
(f a) commercial reasons.
Amendment 751 #
Proposal for a regulation
Article 24 – paragraph 3 a (new)
Article 24 – paragraph 3 a (new)
3 a. In the cases referred to in paragraph 1 point (f), the competent authorities shall forward the information to drinking water and wastewater operators.
Amendment 755 #
Proposal for a regulation
Article 24 – paragraph 4 a (new)
Article 24 – paragraph 4 a (new)
4 a. The national competent authority of the Member State may decide to extend obligations set in paragraph 4 to a specific non-critical medicinal product on a case by case basis.
Amendment 791 #
Proposal for a regulation
Article 31 – paragraph 1 – point b
Article 31 – paragraph 1 – point b
(b) based on the scientific evidence available, the Agency issues an opinion concluding that the medicinal product could be effective in treating, preventing or diagnosing the disease or condition directly related to the public health emergency, and the known and potential benefits of the product outweigh the known and potential risks of the product, taking into consideration the threat posed by the public health emergency.
Amendment 797 #
Proposal for a regulation
Article 32 – paragraph 3
Article 32 – paragraph 3
3. The Agency shall transmit without undue delay to the Commission the scientific opinion and its updates and any recommendations on the temporary emergency marketing authorisation. The scientific opinion and information on the application on the use of temporary emergency marketing authorisation shall be made publicly available by the Agency.
Amendment 802 #
Proposal for a regulation
Article 33 – paragraph 3
Article 33 – paragraph 3
3. Specific conditions mayshall be set to require the completion of ongoing studies or to conduct new studies to ensure the safe and effective use of the medicinal product or minimise its impact on the environment. A time limit for the submission of those studies shall be set.
Amendment 815 #
Proposal for a regulation
Article 36 – paragraph 1
Article 36 – paragraph 1
The marketing authorisation holder of an authorisation in accordance with Article 33 mayshall submit an application in accordance with Articles 5 and 6 in order to obtain an authorisation in accordance with Articles 13, 16 or 19 based on the pre-agreed timelines established with the Agency.
Amendment 820 #
Proposal for a regulation
Chapter III – title
Chapter III – title
III INCENTIVES FOR THE DEVELOPMENT OF ‘PRIORITY ANTIMICROBIALS’deleted
Amendment 827 #
Proposal for a regulation
Article 40
Article 40
Amendment 901 #
Proposal for a regulation
Article 41
Article 41
Amendment 927 #
Proposal for a regulation
Article 42
Article 42
Amendment 941 #
Proposal for a regulation
Article 43
Article 43
Amendment 958 #
Proposal for a regulation
Article 45 – paragraph 4 – subparagraph 1
Article 45 – paragraph 4 – subparagraph 1
The Agency may at any time request the marketing authorisation holder to submit data demonstrating that the benefit-risk balance remains favourable. The marketing authorisation holder shall answer fully and promptlywithin the time limit set to any such request. The marketing authorisation holder shall also respond fully and within the time limit set to any such request of a competent authority regarding the implementation of any measures previously imposed, including risk minimisation measures.
Amendment 960 #
Proposal for a regulation
Article 48 – paragraph 1 – subparagraph 1
Article 48 – paragraph 1 – subparagraph 1
An entity not engaged in an economic activity (‘not-for-profit entity’) may submit to the Agency or to a competent authority of the Member State substantive non- clinical or clinical evidence for a new therapeutic indication that is expected to fulfil an unmet medical need.
Amendment 969 #
Proposal for a regulation
Article 48 – paragraph 1 – subparagraph 2
Article 48 – paragraph 1 – subparagraph 2
The Agency may, at the request of a Member State, the Commission, or on its own initiative and on the basis of all available evidence make a scientific evaluation of the benefit-risk of the use of a medicinal product with a new therapeutic indication that concerns an unmet medical need.
Amendment 972 #
Proposal for a regulation
Article 48 – paragraph 1 – subparagraph 3
Article 48 – paragraph 1 – subparagraph 3
The opinion of the Agency shall be made publicly available and the competent authorities of the Member States and the marketing authorisation holder shall be informed.
Amendment 974 #
Proposal for a regulation
Article 48 – paragraph 3
Article 48 – paragraph 3
Amendment 976 #
Proposal for a regulation
Article 51 – paragraph 3 a (new)
Article 51 – paragraph 3 a (new)
3 a. Competent authorities and the Agency shall have procedures in place to ensure independence, impartiality, transparency and that personnel performing supervisory activities are free from any conflict of interest.
Amendment 978 #
Proposal for a regulation
Article 53 – paragraph 2
Article 53 – paragraph 2
2. In cooperation with the Agency, the Commission mayshall adopt detailed guidelines laying down the principles applicable to those international inspection programmes. The guidelines shall include rules on impartially, independence and conflict of interest of inspectors.
Amendment 981 #
Proposal for a regulation
Article 56 – paragraph 1
Article 56 – paragraph 1
Where the Agency concludes that a holder of a marketing authorisation granted in accordance with Article 19, including a new therapeutic indication granted referred to Article 19, failed to comply with the obligations laid down in the marketing authorisation, or with post-authorisation studies laid down in Article 20, the Agency shall inform the Commission accordingly.
Amendment 987 #
Proposal for a regulation
Article 58 – paragraph 2
Article 58 – paragraph 2
2. In the preparation of the scientific advice referred to in paragraph 1 and upon request by undertakings or, as relevant, not-for-profit entities that requested the scientific advice, the Agency mayshall promote an open discussion about latest scientific developments and the update of scientific guidelines, and where relevant, shall consult experts of the Member States with clinical trial or medical device expertise or the expert panels designated in accordance with Article 106(1) of Regulation (EU) 2017/745.
Amendment 989 #
Proposal for a regulation
Article 58 – paragraph 3
Article 58 – paragraph 3
3. In the preparation of the scientific advice referred to in paragraph 1 and in duly justified cases, the Agency may consult authorities established in other Union legal acts as relevant for the provision of the scientific advice in question or other public bodies established in the Union, as applicablein particular those listed in Article 162 of this Regulation.
Amendment 994 #
Proposal for a regulation
Article 58 – paragraph 4
Article 58 – paragraph 4
4. The Agency shall include in the European public assessment report the key areas of thea detailed log of pre-submission activities, including scientific advice once the corresponding marketing authorisation decision has been taken in relation to the medicinal product, after deletion of any information of a commercially confidential nature.
Amendment 998 #
Proposal for a regulation
Article 58 – paragraph 4 a (new)
Article 58 – paragraph 4 a (new)
4 a. The Agency shall make publicly available and update on a monthly basis the list of products undergoing scientific advise, including the information on the active substance, therapeutic indication, stage of development, type of applicant and date, as well as names and affiliations of staff, rapporteurs and experts involved in the scientific advise. A summary of such information, including statistics per type of developer, indication, affiliations of rapporteurs and experts, shall be published in the Agency’s annual report.
Amendment 1001 #
Proposal for a regulation
Article 58 – paragraph 4 b (new)
Article 58 – paragraph 4 b (new)
4 b. The Agency staff and experts from national competent authorities providing the scientific advice shall not be involved in a subsequent evaluation of marketing authorisation application for the same products. In cases where such situation is unavoidable due to specific expertise, it shall be stated and duly justified in the products’ European Public Assessment Report.
Amendment 1028 #
Proposal for a regulation
Article 60 – paragraph 1 – point c
Article 60 – paragraph 1 – point c
(c) are expected to be of major interest from the point of view of public health, in particular as regards therapeutic innovation, taking into account the early stage of development, or antimicrobials with any of the characteristics mentioned in Article 40(3)provided for in the ‘WHO priority pathogens list for R&D of new antibiotics’, specifically those listed as priority 1 (critical) or priority 2 (high), or taking into account as a priority any equivalent list of priority pathogens adopted at Union level.
Amendment 1045 #
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, including substantiated opinions received from other advisory bodies, after deletion of all information of a commercially confidential nature.
Amendment 1046 #
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’s recommendation, raised by other advisory bodies, 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 1049 #
Proposal for a regulation
Article 62 – paragraph 2
Article 62 – paragraph 2
2. The Commission may ask the Agency and other advisory bodies 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 1050 #
Proposal for a regulation
Article 62 – paragraph 3
Article 62 – paragraph 3
3. The decision of the Commission referred to in paragraph 1 shall be adopted by means of implementing acts, in accordance with the examination procedure referred to in Article 173(2), taking into account the scientific recommendation of the Agency and other advisory bodies.
Amendment 1053 #
Proposal for a regulation
Article 63 – paragraph 2
Article 63 – paragraph 2
Amendment 1060 #
Proposal for a regulation
Article 63 – paragraph 3
Article 63 – paragraph 3
3. The Commission shall adopt the necessary provisions for implementing this Article by means of implementingdelegated acts in accordance with the procedure laid down in Article 173(2)5 in order to further specify the requirements referred to in paragraph 1.
Amendment 1065 #
Proposal for a regulation
Article 64 – paragraph 2 – subparagraph 1 – point d
Article 64 – paragraph 2 – subparagraph 1 – point d
(d) justification that the criteria laid down in Article 63(1) or in the relevant delegated acts adopted in accordance with Article 63(2) are fulfilled and a description of the stage of development, including the expected therapeutic indication.
Amendment 1070 #
Proposal for a regulation
Article 64 – paragraph 4 – subparagraph 1
Article 64 – paragraph 4 – subparagraph 1
The Agency shall adopt a decision granting or refusing the orphan designation based on the criteria referred to in Article 63(1) or in the relevant delegated acts adopted in accordance with Article 63(2) within 90 days of the receipt of a valid application. The application is considered valid if it includes all the particulars and documentation referred to in paragraph 2.
Amendment 1074 #
Proposal for a regulation
Article 64 – paragraph 5
Article 64 – paragraph 5
5. Decisions of the Agency and a summary of consultation referred to in paragraph 4 on granting or refusing the orphan designation shall be made public after deletion of any information of a commercially confidential nature.
Amendment 1096 #
Proposal for a regulation
Article 67 – paragraph 3 – point c a (new)
Article 67 – paragraph 3 – point c a (new)
(c a) the stage of development;
Amendment 1103 #
Proposal for a regulation
Article 68 – paragraph 1 – point a
Article 68 – paragraph 1 – point a
(a) the conduct of the various tests and trials necessary to demonstrate the quality, safety and, efficacy and environmental impact of the medicinal product, as referred to Article 138(1), second subparagraph, point (p);
Amendment 1106 #
Proposal for a regulation
Article 68 – paragraph 2
Article 68 – paragraph 2
2. Medicinal products designated as orphan medicinal products under the provisions of this Regulation shall be eligible for incentives made available by the Union and by the Member States to support research into, and the development and availability of, orphan medicinal products and in particular aid for research for small- and medium-sized undertakings and entities not engaged in economic activity provided for in framework programmes for research and technological development.
Amendment 1112 #
Proposal for a regulation
Article 69 – paragraph 2 – subparagraph 1
Article 69 – paragraph 2 – subparagraph 1
In addition, the applicant shall demonstrate that the medicinal product has been granted an orphan designation and that the criteria set out in Article 63(1) or in the relevant delegated acts adopted in accordance with Article 63(2) are fulfilled for the therapeutic indication sought.
Amendment 1114 #
Proposal for a regulation
Article 69 – paragraph 3 – subparagraph 1
Article 69 – paragraph 3 – subparagraph 1
The Committee for Medicinal Products for Human Use shall assess whether the medicinal product fulfils the requirements set out in Article 63(1) or in the relevant delegated acts adopted in accordance with Article 63(2). In the situation referred in paragraph 2, subparagraph 2, that Committee shall also assess whether the medicinal product addresses a high unmet medical need as specified in Article 70(1).
Amendment 1116 #
Proposal for a regulation
Article 69 – paragraph 4
Article 69 – paragraph 4
4. The orphan marketing authorisation shall cover only those therapeutic indications, which fulfil the requirements set out in Article 63(1) or in the relevant delegated acts adopted in accordance with Article 63(2) at the time when the orphan marketing authorisation is granted.
Amendment 1117 #
Proposal for a regulation
Article 69 – paragraph 6
Article 69 – paragraph 6
6. An applicant may submit an application for a separate marketing authorisation for other indications which do not fulfil the requirements set out in Article 63(1) or in the relevant delegated acts adopted in accordance with Article 63(2).
Amendment 1118 #
Proposal for a regulation
Article 69 – paragraph 6 a (new)
Article 69 – paragraph 6 a (new)
6 a. As laid down in Article 17, authorised products shall be subject to re- evaluation after 5 years. In cases of orphan medicinal products, the Committee for Medicinal Products for Human use shall in addition to the product’s safety, efficacy and environmental impact also review the criteria in set in Article 63 and assess the profitability of the product, taking into account all authorised indications, as laid down in Article 72.
Amendment 1134 #
Proposal for a regulation
Article 70 – paragraph 1 – point a
Article 70 – paragraph 1 – point a
(a) there is no medicinal product authorised in the Union for such condition or where, despite medicinal products being authorised for such condition in the Union, the applicant demonstrates that the orphan medicinal product, in addition to having a significant benefit, will bring exceptional therapeutic advancement; and
Amendment 1142 #
Proposal for a regulation
Article 70 – paragraph 1 – point b
Article 70 – paragraph 1 – point b
(b) the use of the orphan medicinal product results in a meaningfusubstantial reduction in disease morbidity or mortality for the relevant patient population.
Amendment 1166 #
Proposal for a regulation
Article 71 – paragraph 2 – point a
Article 71 – paragraph 2 – point a
(a) nineseven years for orphan medicinal products other than those referred to in points (b) and (c);
Amendment 1186 #
Proposal for a regulation
Article 71 – paragraph 2 – point b
Article 71 – paragraph 2 – point b
(b) teneight years for orphan medicinal products addressing a high unmet medical need as referred to in Article 70;
Amendment 1197 #
Proposal for a regulation
Article 71 – paragraph 2 – point c
Article 71 – paragraph 2 – point c
Amendment 1214 #
Proposal for a regulation
Article 71 – paragraph 4 – point c a (new)
Article 71 – paragraph 4 – point c a (new)
(c a) a compulsory license has been granted in accordance with [Regulation on compulsory licensing for crisis management and amending Regulation (EC) 816/2006].
Amendment 1219 #
Proposal for a regulation
Article 71 – paragraph 7
Article 71 – paragraph 7
7. Where tThe Agency shall adopts scientific guidelines for the application of paragraphs 1 and 4, it shall consult the Commission.
Amendment 1221 #
Proposal for a regulation
Article 72 – title
Article 72 – title
Prolongation and reduction of market exclusivity period
Amendment 1223 #
Proposal for a regulation
Article 72 – paragraph 1
Article 72 – paragraph 1
Amendment 1250 #
Proposal for a regulation
Article 72 – paragraph 2 – subparagraph 1
Article 72 – paragraph 2 – subparagraph 1
The period of market exclusivity shall be prolonged by an additional 126 months for orphan medicinal products referred to in Article 71(2), points (a) and (b), if at least two years before the end of the exclusivity period, the orphan marketing authorisation holder obtains a marketing authorisation for one or more new therapeutic indications for a different orphan condition.
Amendment 1273 #
Proposal for a regulation
Article 72 – paragraph 4
Article 72 – paragraph 4
Amendment 1276 #
Proposal for a regulation
Article 72 – paragraph 4 a (new)
Article 72 – paragraph 4 a (new)
4 a. The market exclusivity period shall be reduced to five years if, at the end of the fifth year, it is established, in respect of the medicinal product concerned, that the criteria laid down in Article 63 are no longer met or where it is shown on the basis of available evidence that the product is sufficiently profitable not to justify maintenance of market exclusivity. The sponsor shall provide the Agency with the information necessary to re- assess the criteria laid down in Article 63 and the externally audited product-related profit margins for all authorised indications at least nine months before end of the fifth year.
Amendment 1357 #
Proposal for a regulation
Article 91 – paragraph 3
Article 91 – paragraph 3
3. When products are authorised in accordance with the provisions of this Regulation, the Commission may update the summary of product characteristics and package leaflet, and may vary the marketing authorisation accordingly, including regarding information on dosage accuracy.
Amendment 1371 #
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 and medication errors, and on those occurring in the course of post- authorisation studies with the medicinal product or associated with occupational exposure.
Amendment 1376 #
Proposal for a regulation
Article 103 – paragraph 3 a (new)
Article 103 – paragraph 3 a (new)
The periodic safety update reports shall, in addition, be made publicly available in the web-portal referred to in Article 135(1)(n).
Amendment 1378 #
Proposal for a regulation
Article 104 – paragraph 1 – subparagraph 1 – point h
Article 104 – paragraph 1 – subparagraph 1 – point h
(h) the initiation of the procedure provided for in Article 41(2), and Articles 114, 115 and 116 of [revised Directive 2001/83/EC], the active substances or medicinal products concerned and the issue being addressed, any public hearings pursuant to that procedure and information on how to submit information and to participate in public hearings;
Amendment 1379 #
Proposal for a regulation
Article 104 – paragraph 1 – subparagraph 1 – point i
Article 104 – paragraph 1 – subparagraph 1 – point i
(i) conclusions of assessments, obligations for post-marketing studies, recommendations, opinions, approvals and decisions taken by the Agency and its Committees under this Regulation and [revised Directive 2001/83/EC], unless it is required that this information is made public by the Agency by other means;.
Amendment 1382 #
Proposal for a regulation
Article 104 – paragraph 2
Article 104 – paragraph 2
2. In the development and review of the web portal, the Agency shall consult relevant stakeholders, including patient and consumer groups, healthcare professionals, non-profit research entities and industry representatives.
Amendment 1383 #
Proposal for a regulation
Article 104 – paragraph 3 – subparagraph 1
Article 104 – paragraph 3 – subparagraph 1
The Agency shall, in collaboration with the Member States and the Commission, set up and maintain a register of environmental risk assessment studies conducted for the purpose of supporting an environmental risk assessment for medicinal products authorised in the Union, unless such information is made public in the Union by different means.
Amendment 1385 #
Proposal for a regulation
Article 104 – paragraph 3 – subparagraph 2
Article 104 – paragraph 3 – subparagraph 2
Information in suchthe register shall be publicly available, unless restrictions are necessary to protect commercially confidential information . For the purpose of setting up such register, the Agency mayshall request marketing authorisation holders and competent authorities to submit results of any such study already completed for products authorised in the Union within [OP please add the date = 24 months after the date of application of this Regulation].
Amendment 1386 #
Proposal for a regulation
Article 109 – paragraph 2
Article 109 – paragraph 2
2. The Agency and the European Monitoring Centre for Drugs and Drug AddictionDrugs Agency shall exchange information that they receive on the abuse of medicinal products including information related to illicit drugs.
Amendment 1396 #
Proposal for a regulation
Chapter IX – title
Chapter IX – title
IX REGULATORY SANDBOXdeleted
Amendment 1397 #
Proposal for a regulation
Article 113
Article 113
Amendment 1449 #
Proposal for a regulation
Article 114
Article 114
Amendment 1456 #
Proposal for a regulation
Article 115
Article 115
Amendment 1486 #
Proposal for a regulation
Article 116 – paragraph 1 – point d
Article 116 – paragraph 1 – point d
(d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder and public authorities, where available, no less than six months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1).
Amendment 1504 #
Proposal for a regulation
Article 117 – paragraph 1 a (new)
Article 117 – paragraph 1 a (new)
1 a. Shortage prevention plans shall be without delay submitted to the competent authority concerned defined in Article 116(1) and be made publicly available, upon request.
Amendment 1518 #
Proposal for a regulation
Article 118 – paragraph 2
Article 118 – paragraph 2
2. For the purposes of paragraph 1, the competent authority concerned as defined in Article 116(1) may request any additional information from the marketing authorisation holder as defined in Article 116(1). In particular, it may request the marketing authorisation holder to submit a shortage mitigation plan in accordance with Article 119(2), a risk assessment of impact of suspension, cessation or withdrawal in accordance with Article 119(3), or the shortage prevention plan referred to in Article 117. The competent authority concerned mayshall set a deadline for the submission of the information requested.
Amendment 1534 #
Proposal for a regulation
Article 120 – paragraph 2
Article 120 – paragraph 2
2. For the purposes of Article 118(1), where relevant, upon request from the competent authority concerned as defined in Article 116(1), entities including other marketing authorisation holders as defined in Article 116(1), importers and manufacturers of medicinal products or active substances and relevant suppliers of these, wholesale distributors, stakeholder representative associations or other persons or legal entities that are authorised or entitled to supply medicinal products to the public shall provide any information requested in a timely manner.
Amendment 1535 #
Proposal for a regulation
Article 121 – paragraph 1 – point -a (new)
Article 121 – paragraph 1 – point -a (new)
(-a) collect and assess the information on potential and actual shortages provided by marketing authorisation holders, importers, manufacturers and suppliers of medicinal products or active substances, wholesale distributors, healthcare professionals, patients and consumers and other persons or legal entities that are authorised or entitled to supply medicinal products to the public;
Amendment 1536 #
Proposal for a regulation
Article 121 – paragraph 1 – point b
Article 121 – paragraph 1 – point b
(b) publish and regularly update information on actual shortages of medicinal products, including date when the shortage occurred, expected duration, the reasons as per Article 24(1) and mitigation measures, in cases in which that competent authority has assessed the shortage, on a publicly available website based on information reported by different stakeholders, on a publicly available website or database interoperable with the European Shortages Monitoring Platform (‘ESMP’), established by Regulation (EU) 2022/123, and ensure such information, including regarding available alternatives, has been proactively communicated to representatives of healthcare professionals and patients;
Amendment 1564 #
Proposal for a regulation
Article 121 – paragraph 6
Article 121 – paragraph 6
6. The Member States may request that the MSSG provide further recommendations, referred to in Article 123(4). Where Member States that take an alternative course of action not in line with the recommendations of the MSSG at national level, they shall share the reasons for doing so with the MSSG in a timely manner.
Amendment 1588 #
Proposal for a regulation
Article 122 – paragraph 6
Article 122 – paragraph 6
6. For the purposes of implementing this Regulation, the Agency shall expand the scope of the ESMP and include, among others, information on the duration, reasons and mitigation measures of medicine shortages. The Agency shall ensure that, where relevant, data is interoperable between the ESMP, Member States’ IT systems and other relevant IT systems and databases, without duplication of reporting.
Amendment 1599 #
Proposal for a regulation
Article 123 – paragraph 4
Article 123 – paragraph 4
4. The MSSG mayshall provide recommendations on measures to resolve or to mitigate the critical shortage, in accordance with the methods referred to in Article 122(4), point (d), an information regarding available alternatives, to relevant marketing authorisation holders, the Member States, the Commission, the representatives of healthcare professionals or other entities.
Amendment 1609 #
Proposal for a regulation
Article 124 – paragraph 2 – subparagraph 2
Article 124 – paragraph 2 – subparagraph 2
For the purposes of this paragraph, the Agency mayshall set a deadline for the submission of the information requested.
Amendment 1618 #
Proposal for a regulation
Article 124 – paragraph 3
Article 124 – paragraph 3
3. The Agency shall establish within its web-portal referred to in Article 104 a publicly available webpage that provides information on actual critical shortages of medicinal products in cases in which the Agency has assessed the shortage and has provided recommendations to healthcare professionals and patients. This webpage shall also provide references to the listdatabases of actual shortages published by the competent authorities of the Member State pursuant to Article 121(1), point (b) and the ESMP.
Amendment 1620 #
Proposal for a regulation
Article 124 – paragraph 3 a (new)
Article 124 – paragraph 3 a (new)
3 a. The web portal referred to in paragraph 3 shall include at least the following information: (a) the name and common name of the medicinal product on critical shortage; (b) the therapeutic indications for the medicinal product on critical shortage; (c) the reason for the critical shortage of the medicinal product; (d) the start and expected duration of the critical shortage of the medicinal product; (e) the Member States affected by the critical shortage of the medicinal product; (f) mitigation measures taken to address the critical shortage of the medicinal product; (g) other relevant information for healthcare professionals and patients, including information on whether alternative medicinal products are available.
Amendment 1644 #
Proposal for a regulation
Article 128 – paragraph 2 a (new)
Article 128 – paragraph 2 a (new)
2 a. The marketing authorisation holder shall set up and maintain a minimum safety stock of critical medicinal products which shall be sufficient to cover two months demand of all Member States where the product has been placed on the market.
Amendment 1645 #
Proposal for a regulation
Article 128 – paragraph 2 b (new)
Article 128 – paragraph 2 b (new)
2 b. By derogation from paragraph 2a, national competent authorities may, in duly justified cases, grant an exemption from stockpiling obligations to the marketing authorisation holder, upon request, or adopt other complementary measures on the safety of stocks.
Amendment 1648 #
Proposal for a regulation
Article 129 – paragraph 1
Article 129 – paragraph 1
For the purposes of Article 127(4) and Article 130(2), point (c), and Article 130(4), point (c), where relevant, upon request from the competent authority concerned as defined in Article 116(1), entities including other marketing authorisation holders as defined in Article 116(1), importers and manufacturers of medicinal products or active substances and relevant suppliers of these, wholesale distributors, stakeholder representative associations or other persons or legal entities that are authorised or entitled to supply medicinal products to the public shall provide any information requested in a timelby the deadline set by the Agency mannerd provide updates whenever necessary.
Amendment 1658 #
Proposal for a regulation
Article 130 – paragraph 1 – subparagraph 1 – point a
Article 130 – paragraph 1 – subparagraph 1 – point a
(a) develop a common methodology to identify critical medicinal products, including the evaluation of vulnerabilities with respect to the supply chain of those medicines, in consultation, where appropriate, with relevant stakeholders in particular patients, consumers and healthcare professionals;
Amendment 1667 #
Proposal for a regulation
Article 130 – paragraph 1 – subparagraph 2
Article 130 – paragraph 1 – subparagraph 2
The Agency shall publish the information referred to in points (b), (c) and (d)aragraph 1 on a dedicated webpage on its web-portal.
Amendment 1668 #
Proposal for a regulation
Article 130 – paragraph 2 – subparagraph 1 – point b
Article 130 – paragraph 2 – subparagraph 1 – point b
(b) the marketing authorisation holder of the medicinal product, including the shortage prevention and mitigation plan, referred to in Article 117 and 119(2);
Amendment 1677 #
Proposal for a regulation
Article 131 – paragraph 1
Article 131 – paragraph 1
1. Following the reporting referred to in Article 130, paragraph 2, second subparagraph, and Article 130(5), the MSSG shall consult the working party referred to in Article 121(1), point (c) as well as representatives of patients, consumers and healthcare professionals. Based on this consultation, the MSSG shall propose a Union list of critical medicinal products authorised to be placed on the market of a Member State pursuant to Article 5 of [revised Directive 2001/83/EC] and for which coordinated Union level action is necessary (“the Union list of critical medicinal products”).
Amendment 1699 #
Proposal for a regulation
Article 134 – paragraph 1 – point -a (new)
Article 134 – paragraph 1 – point -a (new)
(-a) take all necessary action within the limits of the powers conferred on it, with a view to mitigating critical shortages of medicinal products;