Sittings · Document

Draft report (COM(2023)0193 – C9-0144/2023 – 2023/0131(COD)) 2023-11-21

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

Committee on the Environment, Public Health and Food Safety

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Amendment 417

István Ujhelyi

Proposal for a regulation

Recital 102

Text proposed by the Commission

Amendment

(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.

(102) In order to incentivize investment and innovation, research and development of orphan medicines where either no other treatment exists or, if other treatments already exist, they would constitute a significant benefit to the target population a modulation of market exclusivity has been introduced. Such modulation is science-driven and informed by the principles that guide research, with incentives based on the concrete barriers, unique attributes, and needs for development of novel therapies that address patient needs; four main incentive archetypes are foreseen by the Regulation, each addressing unique needs and knowledge gaps in research; market exclusivity for well-established use orphan medicines, 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

Or. en

Amendment 418

Tilly Metz

Proposal for a regulation

Recital 102

Text proposed by the Commission

Amendment

Or. en

Amendment 419

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Billy Kelleher

Proposal for a regulation

Recital 102

Text proposed by the Commission

Amendment

(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; pioneering orphan medicinal products addressing areas where there is a total lack of approved treatments 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.

Or. en

Amendment 420

Tomislav Sokol

Proposal for a regulation

Recital 102

Text proposed by the Commission

Amendment

(102) In order to incentivise research, innovation and development of orphan medicinal products, to ensure market predictability and to ensure a fair distribution of incentives, a modulation of market exclusivity has been introduced; designated as a breakthrough orphan medicinal products 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.

Or. en

Amendment 421

Andrey Slabakov

Proposal for a regulation

Recital 103

Text proposed by the Commission

Amendment

(103) In order to encourage faster and wider access also to orphan medicinal products, an additional period of one year of market exclusivity is granted to orphan medicinal products for a Union market launch, with the exception of well-established use medicinal products.

(103) Ensuring faster and wider access also to orphan medicinal products remains a Union-wide issue. This impacts in particular Member States with smaller purchasing power, smaller populations, and therefore with smaller rare disease patient populations. The result is reduced or delayed access to treatments that are available on the Union market, but not in each Member State. Solutions can only be found through joint action that involves manufacturers, national and Union-level regulators, Member States, clinicians and patients.

Or. en

Amendment 422

Tilly Metz

Proposal for a regulation

Recital 103

Text proposed by the Commission

Amendment

(103) In order to encourage faster and wider access also to orphan medicinal products, an additional period of six months of market exclusivity is granted to orphan medicinal products for a Union market launch, with the exception of well-established use medicinal products.

Or. en

Amendment 423

Andrey Slabakov

Proposal for a regulation

Recital 103 a (new)

Text proposed by the Commission

Amendment

(103 a) Information is key to ensuring access to novel treatments for patients with rare diseases. Large dispariteis remain between Member States as to the level of information access for both clinicians and patients. Without addressing this crucial break of communication starting at the manufacturer of a novel orphan medicinal product and ending with the relevant patient population, awareness of and takeup of novel treatments will remain low. Clinicians must continuously be kept up-to-date with developments in the fields of rare diseases, in order to provide their patients with the best possible treatment. In order to address this gap, action is needed across the board, starting with applicants for a marketing authorisation for an orphan medicinal product. They must prove their commitment to continuously provide the necessary information not only in the Member States where their treatments are sold, but within the entire Union. This can only be achieved with the support of the Agency and with the full cooperation of national and Union-level professional and patient organisations. Member States should take all necessary measures to ensure financial and structural support enabling the flow of information.

Or. en

Amendment 424

Andrey Slabakov

Proposal for a regulation

Recital 103 b (new)

Text proposed by the Commission

Amendment

(103 b) Informing clinicians and other medical professionals of available orphan medicinal products placed on the Union markets should be accopmanied by measures ensuring their upskilling. Member States must invest in the creation of Centres of Excellence for one or a group of rare diseases, with the material base and skilled professionals to offer the latest available treatments. These Centres may be established on a national or regional level. Furthermore, Member States may elect to enter into cooperation and co-financing, in order to establish joint Centres of Excellence, based on their patient populations, territorial proximity, ease of access/travel and material conditions.

Or. en

Amendment 425

Andrey Slabakov

Proposal for a regulation

Recital 103 c (new)

Text proposed by the Commission

Amendment

(103 c) The Union must build on the successful implementation since 2017 of the European Reference Networks (ERNs) for rare diseases. As highlighted in the EU Joint Action on Rare Diseases Plan, the support for and cooperation with the ERNs must be enchanced both from the public and private sectors. Therefore, applicants for market authorisation of orphan medicinal products must prove that they have put in place robust pathways for partnering with ERNs and for the exchange and use of relevant data. Member States must guarantee appropriate levels of funding - an estimated €77 million, in order to realise the full potential of the ERNs.

Or. en

Amendment 426

Andrey Slabakov

Proposal for a regulation

Recital 103 d (new)

Text proposed by the Commission

Amendment

(103 d) Presently, conditions under which a patient may travel from one Member State to another to receive medical care and reimbursement are established in the Directive 2011/24/EU on patients’ rights in cross-border healthcare, as well as in Regulation (EC) No 883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems. Patients seeking cross-border healthcare continue to face issues with regards to their rights, partially due to the incomplete transposition of Directive 2011/24/EU by all Member States. For many patient populations in certain Member States these pathways remain the only way to seek treatment for rare diseases, which are available in other Member States. Directive 2011/24/EU must, therefore, be fully transposed and used by all Member States to guarantee their patients access to orphan medicinal products put on the Union markets.

Or. en

Amendment 427

Tilly Metz

Proposal for a regulation

Recital 104

Text proposed by the Commission

Amendment

(104) To reward research into and development of new therapeutic indications, an additional period of one year of market exclusivity is provided for a new therapeutic indication (with a maximum of two indications).

deleted

Or. en

Amendment 428

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Recital 104

Text proposed by the Commission

Amendment

(104) To maximise the potential benefit of clinical research, continued exploration of new indications should be encouraged. To reward research into and development of new therapeutic indications, an additional period of one year of market exclusivity is provided for a new therapeutic indication (with a maximum of two indications). To continue incentivising innovation, especially in underserved areas, while also allowing generic entry, any subsequent new orphan marketing authorisations granted to the marketing authorisation holder should receive three years of market exclusivity bound to the indication, not the active substance. This will allow generic competition in the first two orphan indications, while allowing for continued research for those patients who could still benefit.

Or. en

Amendment 429

Maria Angela Danzì

Proposal for a regulation

Recital 104

Text proposed by the Commission

Amendment

(104) Undertaking research and clinical trials for a rare disease is a complex and time-consuming activity, mainly because of the small patient population and the lack of knowledge typical of many rare diseases without authorised treatment. Knowledge and experience acquired with clinical trials in an indication is not immediately transferable to a new indication, but may provide important guidance. Therefore, research into new therapeutic indications should be rewarded. Industry must be provided with sufficient incentives to continue exploring new indications and to ensure that patients benefit from incremental innovation and to support new technologies to move to other indications;

Or. it

Amendment 430

Andrey Slabakov

Proposal for a regulation

Recital 104

Text proposed by the Commission

Amendment

(104) Undertaking research and clinical trials for a rare disease is complex and time-consuming, especially due to the small patient population and lack of knowledge that characterises many rare diseases with no authorised treatment. Using the knowledge and experience gained from clinical evidence in one indication is not immediately transferable into a new indication, but it can provide important insights. Therefore, research into and development of new therapeutic indications should be rewarded. Sufficient incentives should be provided so that it is viable for industry to continue exploring new indications and ensure patients benefit from incremental innovation and support new technologies to move into additional indications;

Or. en

Amendment 431

Andrey Slabakov

Proposal for a regulation

Recital 104 a (new)

Text proposed by the Commission

Amendment

(104 a) To address patient needs and maximise the potential benefit of clinical research, innovation should be rewarded where possible. In the case of Orphan Medicinal Products, should a developer identify multiple applications for an active substance, this should be rewarded without acting as a barrier to access. Where a marketing authorisation holder receives a second marketing authorisation for the same active substance, three additional years of market exclusivity should be provided. To continue incentivising innovation, especially in underserved areas while also allowing generic entry, any subsequent new orphan marketing authorisations granted to the marketing authorisation holder should be bound to the indication, not the active substance. This will allow generic competition in the first two orphan indications, while allowing for continued research for those patients who could still benefit.

Or. en

Amendment 432

Andrey Slabakov

Proposal for a regulation

Recital 105

Text proposed by the Commission

Amendment

(105) This Regulation includes several provisions aimed to avoid not-justified benefits being derived from the market exclusivity and to improve accessibility of medicinal products by ensuring faster entry of generics and biosimilars, and similar medicinal products on the market, i.e. on day one after the market exclusivity expires. It also clarifies the concurrence of market exclusivity with data protection and defines situations when a similar medicinal product may be granted a marketing authorisation, despite the ongoing market exclusivity. The market exclusivity of the orphan medicinal product shall not prevent the submission, validation, assessment of an application for and granting of a marketing authorisation for a similar medicinal product, including generics and biosimilars, where the remainder of the duration of the initial market exclusivity is less than two years.

Or. en

Amendment 433

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Ondřej Knotek, Billy Kelleher, Erik Poulsen, Dacian Cioloş

Proposal for a regulation

Recital 105 a (new)

Text proposed by the Commission

Amendment

(105 a) One of the overarching goals of this Regulation is to help meeting the medical needs of patients with rare diseases, to improve the affordability of orphan medicinal products and the patient access to orphan medicinal products across the Union, and to encourage innovation in areas of need. While other Union programmes and policies also contribute to these goals, people living with a rare disease continue to face common challenges that are many and multifactorial, including delayed diagnoses, lack of available transformative treatments, and difficulties to access treatments where they live, reflecting the fragmentation of the market across the Member States. The European added value to addressing the needs of people living with a rare disease being exceptionally high due to the rarity of patients, experts, data, and resources, it is appropriate for the Commission to develop, to complement this Regulation, a dedicated framework for rare diseases to bridge relevant legislation, policies and programmes, and support national strategies with a view to better meet the unmet needs of people living with rare diseases and their carers. This framework should be needs driven and goals based, and developped in consultation with the Member States and patient organisations as well as, where relevant, other interested parties.

Or. en

Justification

This amendment is in line with the Parliament's call for an EU Action Plan on rare and neglected diseases (European Parliament resolution of 10 July 2020 on the EU’s public health strategy post-COVID-19)

https://www.europarl.europa.eu/doceo/document/TA-9-2020-0205_EN.html

Amendment 434

Maria Angela Danzì

Proposal for a regulation

Recital 106

Text proposed by the Commission

Amendment

(106) Before a medicinal product for human use is placed on the market in one or more Member States, it has to have undergone extensive studies, including non-clinical tests and clinical trials, to ensure that it is safe, of high quality and effective for use in the target population. It is important that such studies are undertaken also on the paediatric population in order to ensure that medicinal products are appropriately authorised for use in the paediatric population, and to improve the information available on the use of medicinal products in the various paediatric population. It is also important that medicinal products are presented in dosages and formulations adequate for the use in children.

(106) Before a medicinal product for human use is placed on the market in one or more Member States, it has to have undergone extensive studies, including non-clinical tests and clinical trials, to ensure that it is safe, of high quality and effective for use in the target population. It is imperative that such studies are undertaken also on the paediatric population in order to ensure that medicinal products are appropriately authorised for use in the paediatric population, and to improve the information available on the use of medicinal products in the various paediatric population. It is also important that medicinal products are presented in dosages and formulations adequate for the use in children.

Or. it

Justification

The obligation introduced by the Paediatric Regulation to carry out paediatric studies cannot be abolished. Therefore, the wording 'is important' is not appropriate and should be changed to 'is imperative'.

Amendment 435

Andrey Slabakov

Proposal for a regulation

Recital 110

Text proposed by the Commission

Amendment

(110) In order to not endanger the health of children and avoid to expose them to unnecessary clinical trials, the obligation to agree and conduct paediatric studies in children should be waived when the medicinal product is likely to be ineffective or unsafe in part or all of the paediatric population, the specific medicinal product does not represent a significant therapeutic benefit over existing treatments for children or the disease for which the medicinal product is intended occurs only in adult populations. Nevertheless, in the last case, if on the basis of existing scientific evidence, the medicinal product due to its molecular mechanism of action is expected to be effective against a different disease in children, the obligation should be maintained.

Or. en

Amendment 436

Maria Angela Danzì

Proposal for a regulation

Recital 112

Text proposed by the Commission

Amendment

(112) With a view to ensuring that research is conducted only when safe and ethical and that the requirement for study data in the paediatric population does not block or delay the authorisation of medicinal products for other populations, the Agency may defer the initiation or completion of some or all of the measures contained in a paediatric investigation plan for a limited period of time. Such deferral should be extended only in duly justified cases.

(112) With a view to ensuring that research is conducted only when safe and ethical and that the requirement for study data in the paediatric population does not block or delay the authorisation of medicinal products for other populations, the Agency may defer the initiation or completion of some or all of the measures contained in a paediatric investigation plan for a limited period of time. The length of the deferral shall be specified in a decision of the Agency and shall ensure that the PIP is completed no more than two years after the marketing authorisation for other populations is granted.

Or. it

Justification

One of the main problems, even during the period covered by the Paed. Regulation is the time it takes for paediatric indications/formulations to arrive on the market after the approval of the MA of the adult product. It often takes 7 years or longer. It is unethical to maintain this large discrepancy and the delay should be reduced by urging sponsors to complete studies in good time.

Amendment 437

Andrey Slabakov

Proposal for a regulation

Recital 112

Text proposed by the Commission

Amendment

(112) With a view to ensuring that research is conducted only when safe and ethical and that the requirement for study data in the paediatric population does not block or delay the authorisation of medicinal products for other populations, the Agency may defer the initiation or completion of some or all of the measures contained in a paediatric investigation plan. Such deferral should be extended only in duly justified cases.

Or. en

Amendment 438

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Recital 126

Text proposed by the Commission

Amendment

(126) It is necessary to take measures for the supervision of medicinal products authorised by the Union, and in particular for the intensive supervision of undesirable effects of these medicinal products within the framework of Union pharmacovigilance activities, so as to ensure the rapid withdrawal from the market of any medicinal product presenting a negative benefit-risk balance under normal conditions of use.

(126) It is necessary to take measures for the supervision of medicinal products authorised by the Union, and in particular for the intensive supervision of undesirable effects of these medicinal products, and the collection of real-world data within the framework of Union pharmacovigilance activities, so as to ensure the rapid withdrawal from the market of any medicinal product presenting a negative benefit-risk balance under normal conditions of use.

Or. en

Amendment 439

Tomislav Sokol

Proposal for a regulation

Recital 129

Text proposed by the Commission

Amendment

(129) Scientific and technological progresses in data analytics and data infrastructure are essential for the development, authorisation and supervision of medicinal products. The digital transformation has affected regulatory decision-making, making it more data-driven and multiplying the possibilities to access evidence, across the life cycle of a medicinal product. This Regulation recognises the Agency’s experience and capacity to access and analyse data submitted independently from the marketing authorisation applicant or marketing authorisation holder. On this basis, the Agency should take initiative to update the summary of product characteristics in case new efficacy or safety data has an impact on the benefit-risk balance of a medicinal product.

(129) Scientific and technological progresses in data analytics and data infrastructure are essential for the development, authorisation and supervision of medicinal products. The digital transformation has affected regulatory decision-making, making it more data-driven and multiplying the possibilities to access evidence, across the life cycle of a medicinal product. This Regulation recognises the Agency’s experience and capacity to access and analyse data submitted independently from the marketing authorisation applicant or marketing authorisation holder. On the basis of the totality of evidence made available to the Agency, the Agency should be able to propose updates to the summary of product characteristics in case new evidence has an impact on the benefit risk balance of a medicinal product. In such case, the Agency and the marketing authorisation holder should collaborate to determine the particulars of any such update.

Or. en

Amendment 440

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Recital 129

Text proposed by the Commission

Amendment

(129) Scientific and technological progresses in data analytics and data infrastructure are essential for the development, authorisation and supervision of medicinal products. The digital transformation has affected regulatory decision-making, making it more data-driven and multiplying the possibilities to access evidence and real-world data, across the life cycle of a medicinal product. This Regulation recognises the Agency’s experience and capacity to access and analyse data submitted independently from the marketing authorisation applicant or marketing authorisation holder. On this basis, the Agency should take initiative to update the summary of product characteristics in case new efficacy or safety data has an impact on the benefit-risk balance of a medicinal product. In such case, the Agency and the marketing authorisation holder should collaborate to determine the particulars of any such update.

Or. en

Amendment 441

Tilly Metz

Proposal for a regulation

Recital 132

Text proposed by the Commission

Amendment

(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.

(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. 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.

Or. en

Amendment 442

Tomislav Sokol, Stelios Kympouropoulos

Proposal for a regulation

Recital 132 a (new)

Text proposed by the Commission

Amendment

(132 a) To ensure patients’ access to innovative medicines, it is appropriate to establish common rules for the testing and authorisation of innovative medicinal products and innovative technologies related to such products that, due to their exceptional nature or characteristics, are expected to not completely fit the EU medicines regulatory framework.

Or. en

Amendment 443

Frédérique Ries

Proposal for a regulation

Recital 132 a (new)

Text proposed by the Commission

Amendment

(132 a) To ensure access to innovative medicines, it is appropriate to establish common rules for the testing and authorisation of innovative medicinal products and innovative technologies related to such products that, due to their exceptional nature or characteristics, are expected to not completely fit the Union medicines regulatory framework.

Or. en

Amendment 444

Frédérique Ries

Proposal for a regulation

Recital 132 b (new)

Text proposed by the Commission

Amendment

(132 b) Regulatory sandboxes may be set up when it is not possible to develop the medicinal product or category of products in compliance with the requirements applicable to medicinal products due to scientific or regulatory challenges arising from characteristics or methods related to the product, and those characteristics or methods positively and distinctively contribute to the quality, safety or efficacy of the medicinal product or category of products, or provide a major advantage contribution to patient access to treatment.

Or. en

Amendment 445

Tomislav Sokol

Proposal for a regulation

Recital 132 b (new)

Text proposed by the Commission

Amendment

(132 b) Regulatory sandboxes may be set up when it is not possible to develop the medicinal product or category of products in compliance with the requirements applicable to medicinal products due to scientific or regulatory challenges arising from characteristics or methods related to the product, and those characteristics or methods positively and distinctively contribute to the quality, safety or efficacy of the medicinal product or category of products or provide a major advantage contribution to patient access to treatment.

Or. en

Amendment 446

Tomislav Sokol

Proposal for a regulation

Recital 132 c (new)

Text proposed by the Commission

Amendment

(132 c) The objectives of the regulatory sandboxes should be: for the Agency and national competent authorities to increase their understanding of technical and scientific developments, to allow developers in a controlled environment to test and develop innovative medicinal products and related technologies that are not fitting the current regulatory framework, as agreed with the competent authorities, and to identify possible future adaptations of the legal framework.

Or. en

Amendment 447

Frédérique Ries

Proposal for a regulation

Recital 132 c (new)

Text proposed by the Commission

Amendment

(132 c) The regulatory sandboxes will allow for the Agency and national competent authorities to increase their understanding of technical and scientific developments, for developers to test and develop in a controlled environment innovative medicinal products and related technologies that do not fit the current regulatory framework, in agreement with the competent authorities, and make it possible to identify possible future adaptations of the legal framework.

Or. en

Amendment 448

Tilly Metz

Proposal for a regulation

Recital 133

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 449

Tomislav Sokol, Stelios Kympouropoulos

Proposal for a regulation

Recital 133

Text proposed by the Commission

Amendment

(133) Regulatory sandboxes can provide the opportunity for advancing regulation through proactive regulatory learning, enabling regulators to gain better regulatory knowledge and to find the best means to regulate innovations based on real-world evidence, especially at a very early stage of development of a medicinal product, which can be particularly significant in the face of high uncertainty and disruptive challenges, as well as when preparing new policies. It is important to ensure that SMEs and startups can easily access sandboxes in order to be able to contribute with their knowhow and experience. Regulatory sandboxes are controlled frameworks which, by providing a structured context for experimentation, enable where appropriate in a real-world environment the testing of innovative technologies, products, services or approaches – at the moment particularly in the context of digitalisation or the use of artificial intelligence and machine learning in the life cycle of medicinal products from drug discovery, development to the administration of medicinal products – for a limited time and in a limited part of a sector or area under regulatory supervision ensuring that appropriate safeguards are in place. They allow the authorities tasked with implementing and enforcing the legislation to exercise on a case-by-case basis and in exceptional circumstances a degree of flexibility in relation to testing innovative technologies, for the benefit of bringing these products to patients without compromising the standards of quality, safety and efficacy. In its conclusions of 23 December 2020 the Council has encouraged the Commission to consider the use of regulatory sandboxes on a case-by-case basis when drafting and reviewing legislation.

Or. en

Amendment 450

Frédérique Ries

Proposal for a regulation

Recital 133

Text proposed by the Commission

Amendment

(133) Regulatory sandboxes can provide the opportunity for advancing regulation through proactive regulatory learning, enabling regulators to gain better regulatory knowledge and to find the best means to regulate innovations based on real-world evidence, especially at a very early stage of development of a medicinal product, which can be particularly important in the face of high uncertainty and disruptive challenges, as well as when preparing new policies. It is important to ensure that SMEs and startups can easily access sandboxes in order to be able to contribute with their knowhow and experience. Regulatory sandboxes are controlled frameworks which, by providing a structured context for experimentation, enable where appropriate in a real-world environment the testing of innovative technologies, products, services or approaches – at the moment especially in the context of digitalisation or the use of artificial intelligence and machine learning in the life cycle of medicinal products from drug discovery, development to the administration of medicinal products – for a limited time and in a limited part of a sector or area under regulatory supervision ensuring that appropriate safeguards are in place. They allow the authorities tasked with implementing and enforcing the legislation to exercise on a case-by-case basis and in exceptional circumstances a degree of flexibility in relation to testing innovative technologies, for the benefit of bringing these products to patients without compromising the standards of quality, safety and efficacy. In its conclusions of 23 December 2020 the Council has encouraged the Commission to consider the use of regulatory sandboxes on a case-by-case basis when drafting and reviewing legislation.

Or. en

Amendment 451

Maria Angela Danzì

Proposal for a regulation

Recital 133

Text proposed by the Commission

Amendment

(133) Regulatory sandboxes can provide the opportunity for advancing regulation through proactive regulatory learning, enabling regulators to gain better regulatory knowledge and to find the best means to regulate innovations based on real-world evidence, especially at a very early stage of development of a medicinal product, which can be particularly important in the face of high uncertainty and disruptive challenges, as well as when preparing new policies. Regulatory sandboxes provide a structured context for experimentation, enable where appropriate in a real-world environment the testing of innovative technologies, products, services or approaches – at the moment especially in the context of non-pharmacological therapies, digitalisation or the use of artificial intelligence and machine learning in the life cycle of medicinal products from drug discovery, development to the administration of medicinal products, including where medical devices or in vitro diagnostics are used as combined products – for a limited time and in a limited part of a sector or area under regulatory supervision ensuring that appropriate safeguards are in place. In its conclusions of 23 December 2020 the Council has encouraged the Commission to consider the use of regulatory sandboxes on a case-by-case basis when drafting and reviewing legislation.

Or. it

Justification

The regulatory sandboxes' scope of application must be as wide as possible with a view to fostering technological developments, including improvements to drug-device combination products.

Amendment 452

Billy Kelleher, Catherine Amalric

Proposal for a regulation

Recital 133

Text proposed by the Commission

Amendment

(133) Regulatory sandboxes can provide the opportunity for advancing regulation through proactive regulatory learning, enabling regulators to gain better regulatory knowledge and to find the best means to regulate innovations based on real-world evidence, especially at a very early stage of development of a medicinal product, which can be particularly important in the face of high uncertainty and disruptive challenges, as well as when preparing new policies. Regulatory sandboxes provide a structured context for experimentation, enable where appropriate in a real-world environment the testing of innovative technologies, products, regulatory methods services or approaches – at the moment especially in the context of digitalisation or the use of artificial intelligence and machine learning in the life cycle of medicinal products from drug discovery, development to the administration of medicinal products, including where medical devices or in-vitro diagnostics are used as combination products – for a limited time and in a limited part of a sector or area under regulatory supervision ensuring that appropriate safeguards are in place. In its conclusions of 23 December 2020 the Council has encouraged the Commission to consider the use of regulatory sandboxes on a case-by-case basis when drafting and reviewing legislation.

Or. en

Amendment 453

Andrey Slabakov

Proposal for a regulation

Recital 133

Text proposed by the Commission

Amendment

(133) Regulatory sandboxes can provide the opportunity for advancing regulation through proactive regulatory learning, enabling regulators to gain better regulatory knowledge and to find the best means to regulate innovations based on real-world evidence, especially at a very early stage of development of a medicinal product, which can be particularly important in the face of high uncertainty and disruptive challenges, as well as when preparing new policies. Regulatory sandboxes provide a structured context for experimentation, enable where appropriate in a real-world environment the testing of innovative technologies, products, regulatory methods, services or approaches – at the moment especially in the context of digitalisation or the use of artificial intelligence and machine learning in the life cycle of medicinal products from drug discovery, development to the administration of medicinal products including where medical devices or in-vitro diagnostics are used as combination products – for a limited time and in a limited part of a sector or area under regulatory supervision ensuring that appropriate safeguards are in place. In its conclusions of 23 December 2020 the Council has encouraged the Commission to consider the use of regulatory sandboxes on a case-by-case basis when drafting and reviewing legislation.

Or. en

Amendment 454

Stelios Kympouropoulos

Proposal for a regulation

Recital 133

Text proposed by the Commission

Amendment

(133) Regulatory sandboxes can provide the opportunity for advancing regulation through proactive regulatory learning, enabling regulators to gain better regulatory knowledge and to find the best means to regulate innovations based on real-world evidence, especially at a very early stage of development of a medicinal product, which can be particularly important in the face of high uncertainty and disruptive challenges, as well as when preparing new policies. Regulatory sandboxes provide a structured context for experimentation, enable where appropriate in a real-world environment the testing of innovative technologies, products, services or approaches – at the moment especially in the context of digitalisation or the use of artificial intelligence and machine learning technologies, such as in silico methods, predictive medicine, and data analytics, in the life cycle of medicinal products from drug discovery, development to the administration of medicinal products – for a limited time and in a limited part of a sector or area under regulatory supervision ensuring that appropriate safeguards are in place. In its conclusions of 23 December 2020 the Council has encouraged the Commission to consider the use of regulatory sandboxes on a case-by-case basis when drafting and reviewing legislation.

Or. en

Justification

The in silico methods present an acknowledged potential to support regulatory risk assessment, as recognized by the European Commission (https://data.europa.eu/doi/10.2788/98567), which justifies their inclusion in the provisions related to regulatory sandboxes.

Amendment 455

Fulvio Martusciello

Proposal for a regulation

Recital 133

Text proposed by the Commission

Amendment

Or. en

Amendment 456

Tilly Metz

Proposal for a regulation

Recital 134

Text proposed by the Commission

Amendment

(134) In the area of medicinal products, a high level of protection of inter alia citizens, consumers, health, as well as legal certainty, a level playing field and fair competition always need to be ensured and existing levels of protection need to be respected.

deleted

Or. en

Amendment 457

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Billy Kelleher, Erik Poulsen, Dacian Cioloş

Proposal for a regulation

Recital 134

Text proposed by the Commission

Amendment

Or. en

Amendment 458

Sirpa Pietikäinen

Proposal for a regulation

Recital 134

Text proposed by the Commission

Amendment

(134) In the area of medicinal products, a high level of protection of inter alia citizens, consumers, health, the environment, as well as legal certainty, a level playing field and fair competition always need to be ensured and existing levels of protection need to be respected.

Or. en

Amendment 459

Tomislav Sokol

Proposal for a regulation

Recital 134

Text proposed by the Commission

Amendment

Or. en

Amendment 460

Fulvio Martusciello

Proposal for a regulation

Recital 134

Text proposed by the Commission

Amendment

Or. en

Amendment 461

István Ujhelyi

Proposal for a regulation

Recital 134 a (new)

Text proposed by the Commission

Amendment

(134 a) Member States may introduce or maintain more robust provisions than those provided for in this Regulation with regard to the security of supply of and the availability of medicinal products, only in consistent and coordinated way.

Or. en

Amendment 462

Tilly Metz

Proposal for a regulation

Recital 135

Text proposed by the Commission

Amendment

(135) The establishment of a regulatory sandbox should be based on a Commission Decision following a recommendation of the Agency. Such decision should be based on a detailed plan outlining the particularities of the sandbox as well as describing the products to be covered. A regulatory sandbox should be limited in duration and may be terminated at any time based on public health considerations. The learning stemming from a regulatory sandbox should inform future changes to the legal framework to fully integrate the particular innovative aspects into the medicinal product regulation. Where appropriate, adapted frameworks may be developed by the Commission on the basis of the results of a regulatory sandbox.

deleted

Or. en

Amendment 463

Tomislav Sokol

Proposal for a regulation

Recital 135

Text proposed by the Commission

Amendment

(135) The establishment of a regulatory sandbox should be based on a Commission Decision following a recommendation of the Agency. Such decision should be based on a detailed and comprehensive plan outlining the specificities of the sandbox as well as describing the products to be covered. A regulatory sandbox should be limited in duration and may be terminated at any time based on public health considerations. The learning stemming from a regulatory sandbox should inform future changes to the legal framework to fully integrate the particular innovative aspects into the medicinal product regulation. Where suitable, adapted frameworks may be developed by the Commission on the basis of the results of a regulatory sandbox.

Or. en

Amendment 464

Fulvio Martusciello

Proposal for a regulation

Recital 135

Text proposed by the Commission

Amendment

(135) The establishment of a regulatory sandbox should be based on a Commission Decision following a recommendation of the Agency. Such decision should be based on a detailed plan outlining the specificities of the sandbox as well as describing the products to be covered. A regulatory sandbox should be limited in duration and may be terminated at any time based on public health considerations. The learning stemming from a regulatory sandbox should inform future changes to the legal framework to fully integrate the particular innovative aspects into the medicinal product regulation. Where suitable, adapted frameworks may be developed by the Commission on the basis of the results of a regulatory sandbox.

Or. en

Amendment 465

Tiemo Wölken

Proposal for a regulation

Recital 135 a (new)

Text proposed by the Commission

Amendment

(135 a) The EU market for medicines remains fragmented, despite the EU having a single market and being the second largest market for pharmaceuticals in the world. The organisation of healthcare systems is a national competence of Member States: this allows decisions closer to the patient, but also brings major divergences in both pricing and patient access. Better and closer coordination between national authorities opens the door to a more efficient and effective supply of medicines throughout the EU. The reform of the EU pharmaceutical legislation is essential to take the work on critical shortages and security of supply forward, building a pharmaceutical ecosystem that is competitive, future-proof and with a single market in medicines benefitting all Europeans. Furthermore, its goal are to prevent or mitigate critical shortages at EU level and to assure a particular focus on the critical medicines for which security of supply needs to be assured in the EU at all times, in normal times, and in times of crisis.

Or. en

Amendment 466

Tiemo Wölken

Proposal for a regulation

Recital 135 b (new)

Text proposed by the Commission

Amendment

(135 b) More often, Member States experienced critical shortages of certain antibiotics, endangering the health of patients and risking the development of antimicrobial resistance. These critical shortages were the result of changing infection patterns, which strongly increased demand. On the supply side, the long lead times needed to boost production made it difficult to respond quickly. This experience underlined the need for a dedicated effort – from the industry, as well as from Member States and the EU level to address the issue of critical shortages.

Or. en

Amendment 467

Andrey Slabakov

Proposal for a regulation

Recital 136

Text proposed by the Commission

Amendment

(136) Shortages of medicinal products represent a growing threat to public health, with potential serious risks to the health of patients in the Union and impacts on the right of patients to access appropriate medical treatment. The root causes of shortages are multifactorial. The primary root cause of shortages is the economic model for medicines in Europe, and especially for generic medicines. Other challenges can be identified along the entire pharmaceutical value chain, from quality and manufacturing problems. In particular, shortages of medicinal products can result from supply chain disruptions and vulnerabilities affecting the supply of key ingredients and components. Therefore, marketing authorisation holders of critical and strategic medicinal products, and especially those that do not have alternatives, should have shortage prevention plans in place, to prevent shortages. The Agency should provide guidance to marketing authorisation holders on approaches to streamline the implementation of those plans. Preventing and monitoring shortages should also go through better use of data, including from existing IT systems such as the European Medicines Verification System which can aid in the monitoring and timely response to supply shortages, and has the potential to detect supply issues through predictive models.

Or. en

Amendment 468

Dolors Montserrat

Proposal for a regulation

Recital 136

Text proposed by the Commission

Amendment

(136) Shortages of medicinal products represent a growing threat to public health, with potential serious risks to the health of patients in the Union and impacts on the right of patients to access appropriate medical treatment. The root causes of shortages are multifactorial, with challenges identified along the entire pharmaceutical value chain, from quality and manufacturing problems. In particular, shortages of medicinal products can result from supply chain disruptions and vulnerabilities affecting the supply of key ingredients and components. Therefore, all marketing authorisation holders should have shortage prevention plans in place for critical medicinal products, and especially those that do not have alternatives, to prevent shortages. The Agency should provide guidance to marketing authorisation holders on approaches to streamline the implementation of those plans. Preventing and monitoring shortages should also go through better use of data, including from existing IT systems such as the European Medicines Veryfication System, which can aid in the monitoring and timely response to supply shortages, and has the potential to detect supply issues through predictive models.

Or. en

Amendment 469

Nathalie Colin-Oesterlé

Proposal for a regulation

Recital 136

Text proposed by the Commission

Amendment

(136) Shortages of medicinal products, which have increased twentyfold over the past 20 years in the European Union, are a genuine health scourge, with potential serious risks to the health of patients in the Union and impacts on the right of patients to access appropriate medical treatment. The root causes of shortages are multifactorial, with challenges identified along the entire pharmaceutical value chain, from quality and manufacturing problems. In particular, shortages of medicinal products can result from supply chain disruptions and vulnerabilities affecting the supply of key ingredients and components, while 45% of medicinal products marketed in the EU are not produced in the EU and 80 to 85% of the active ingredients are imported from China and India. Therefore, all marketing authorisation holders should have shortage prevention plans in place to prevent shortages of medicinal products included on the Union list of critical medicinal products, and in particular medicines of health and strategic interest (MHSI). The Agency should provide guidance to marketing authorisation holders on approaches to streamline the implementation of those plans.

Or. fr

Amendment 470

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Ondřej Knotek, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Recital 136

Text proposed by the Commission

Amendment

(136) Shortages of medicinal products represent a growing threat to public health, with potential serious risks to the health of patients in the Union and impacts on the right of patients to access appropriate medical treatment, including longer delays or interruptions in care or therapy, longer periods of hospitalisation, increased risks of exposure to falsified medicinal products, medication errors, adverse effects resulting from the substitution of unavailable medicinal products with alternative ones, significant psychological distress for patients and increased costs for healthcare systems. The root causes of shortages are multifactorial, with challenges identified along the entire pharmaceutical value chain, from quality and manufacturing problems. In particular, shortages of medicinal products can result from supply chain disruptions and vulnerabilities affecting the supply of key ingredients and components. Therefore, all marketing authorisation holders should have shortage prevention plans in place, to prevent shortages. The Agency should provide guidance to marketing authorisation holders on approaches to streamline the implementation of those plans.

Or. en

Amendment 471

István Ujhelyi

Proposal for a regulation

Recital 136

Text proposed by the Commission

Amendment

Or. en

Amendment 472

Marian-Jean Marinescu

Proposal for a regulation

Recital 136

Text proposed by the Commission

Amendment

Or. en

Justification

price differences among Member States, quite substantial in some cases, favour parallel trade that sometimes lead to a medicine crisis in some Member States

Amendment 473

István Ujhelyi

Proposal for a regulation

Recital 137

Text proposed by the Commission

Amendment

(137) To achieve a better security of supply for medicinal products in the internal market and to contribute thereby to a high level of public health protection, it is appropriate to approximate the rules on monitoring and reporting of actual or potential shortages of medicinal products, including the procedures and the respective roles and obligations of concerned entities in this Regulation. It is important to ensure continued supply of medicinal products, which is often taken for granted across Europe. This is especially true for the most critical medicinal products which are essential to ensure the continuity of care, the provision of quality healthcare and guarantee a high level of public health protection in Europe. To combat certain shortages, medicinal products prepared for individual patients in a pharmacy according to a medical prescription “magistral formula”, or according to the pharmacopoeia and intended to be supplied directly to patients served by the pharmacy “officinal formula”, may be used. Member States may introduce or maintain additional robust measures to achieve security of supply of medicines, only when in consistent and coordinated way with the safeguards provided for in this Regulation.

Or. en

Amendment 474

Tiemo Wölken

Proposal for a regulation

Recital 137

Text proposed by the Commission

Amendment

(137) To achieve a better security of supply for medicinal products in the internal market and to contribute thereby to a high level of public health protection, it is appropriate to approximate the rules on monitoring and reporting of actual or potential shortages of medicinal products, including the procedures and the respective roles and obligations of concerned entities in this Regulation. It is important to ensure continued supply of medicinal products, which is often taken for granted across Europe. This is especially true for the most critical medicinal products which are essential to ensure the continuity of care, the provision of quality healthcare and guarantee a high level of public health protection in Europe. To counter certain shortages, medicinal products prepared for individual patients in a pharmacy according to a medical prescription “magistral formula”, or according to the pharmacopoeia and intended to be supplied directly to patients served by the pharmacy “officinal formula”, may be used. Member States should be able to introduce or maintain more robust measures to achieve security of supply for medicines than the safeguards provided for in this Regulation.

Or. en

Amendment 475

Sirpa Pietikäinen

Proposal for a regulation

Recital 137

Text proposed by the Commission

Amendment

Or. en

Amendment 476

Nathalie Colin-Oesterlé

Proposal for a regulation

Recital 137

Text proposed by the Commission

Amendment

(137) To combat shortages of medicinal products, a better security of supply for medicinal products in the internal market is a key element contributing to a high level of public health protection; it is appropriate, therefore, to approximate the rules on monitoring and reporting of actual or potential shortages of medicinal products, including the procedures and the respective roles and obligations of concerned entities in this Regulation. It is important to ensure continued supply of medicinal products, which is often taken for granted across Europe, in particular by making security of supply a criterion as important as the price in public pharmacy contracts and in medicine-related procurement. This is especially true for the most critical medicinal products which are essential to ensure the continuity of care, the provision of quality healthcare and guarantee a high level of public health protection in Europe.

Or. fr

Amendment 477

Catherine Amalric, Max Orville, Billy Kelleher, Erik Poulsen, Dacian Cioloş

Proposal for a regulation

Recital 137

Text proposed by the Commission

Amendment

(137) To achieve a better security of supply for medicinal products in the internal market and to contribute thereby to a high level of public health protection, it is appropriate to approximate the rules on monitoring and reporting of actual or potential shortages of medicinal products, including the procedures and the respective roles and obligations of concerned entities in this Regulation, while allowing Member States to adopt or maintain legislation ensuring a higher degree of protection against medicine shortages, in respect of the commitments taken in the framework of the "Voluntary Solidarity Mechanism for medicines". It is important to ensure continued supply of medicinal products, which is often taken for granted across Europe. This is especially true for the most critical medicinal products which are essential to ensure the continuity of care, the provision of quality healthcare and guarantee a high level of public health protection in Europe.

Or. en

Amendment 478

Andrey Slabakov

Proposal for a regulation

Recital 137

Text proposed by the Commission

Amendment

(137) To achieve a better security of supply for medicinal products in the internal market and to contribute thereby to a high level of public health protection, it is appropriate to approximate the rules on monitoring and reporting of actual or potential shortages of medicinal products, including the procedures and the respective roles and obligations of concerned entities in this Regulation. It is important to ensure continued supply of medicinal products, which is often taken for granted across Europe. This is especially true for the most critical medicinal products which are essential to ensure the continuity of care, the provision of quality healthcare and guarantee a high level of public health protection in Europe. Member States may indroduce measures to ensure the security of supply of critical or strategic medicinal products on national level according their needs.

Or. en

Amendment 479

Andrey Slabakov, Elisabetta De Blasis

Proposal for a regulation

Recital 138

Text proposed by the Commission

Amendment

(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 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. 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 patient 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.

(138) The national competent authorities and the Agency 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 in a centralised, digitalised and automated system. When critical shortages are identified, both national competent authorities and the Agency should work in a coordinated manner to 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. 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 patient 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 or the Agency. 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 creation of strategic reserves are taken.

_________________

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).

Or. en

Amendment 480

Susana Solís Pérez, Frédérique Ries

Proposal for a regulation

Recital 138

Text proposed by the Commission

Amendment

(138) The national competent authorities and the Agency 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 in a centralised, digitalised and automated system. When critical shortages are identified, both national competent authorities and the Agency should work in a coordinated manner to 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. 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 patient 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.

_________________

Or. en

Amendment 481

Tilly Metz

Proposal for a regulation

Recital 138

Text proposed by the Commission

Amendment

(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 importers, 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 Council, 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

_________________

Or. en

Amendment 482

Catherine Amalric, Max Orville, Billy Kelleher, Dacian Cioloş

Proposal for a regulation

Recital 138

Text proposed by the Commission

Amendment

(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 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. 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 patient 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. Health professional and patient organisations should be consulted before the adoption of the list. 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 minimum safety-stocks, are taken by marketing authorisation holders, wholesale distributors or other relevant entities.

_________________

Or. en

Amendment 483

Nathalie Colin-Oesterlé

Proposal for a regulation

Recital 138

Text proposed by the Commission

Amendment

(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 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. 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 patient 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.

(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 continuously and in real time, also based on notifications of marketing authorisation holders. To this end, the Agency should set up a European platform on stocks of medicinal products which is continuously updated in real time with data transmitted by the competent authorities of the Member States, marketing authorisation holders and wholesale distributors. When critical shortages are identified, both national competent authorities and the Agency should work in a coordinated manner to 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. 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 patient 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, prioritising medicines of health and strategic interest (MHSI), 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. These recommendations may relate to national stockpiling initiatives to ensure that they are proportionate to needs and do not have undesirable consequences, such as supply tensions in other Member States. 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

_________________

Or. fr

Amendment 484

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Billy Kelleher, Erik Poulsen, Dacian Cioloş

Proposal for a regulation

Recital 138

Text proposed by the Commission

Amendment

_________________

Or. en

Amendment 485

Marian-Jean Marinescu

Proposal for a regulation

Recital 138

Text proposed by the Commission

Amendment

(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 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 to identify the cause or causes of the respective critical shortage. If the critical shortage is triggered by a marketing authorisation holder, wholesale distributor or other legal entity, the Commission should be able to impose sanctions. 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 patient 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.

_________________

Or. en

Justification

Identifying the causes of shortages and the responsibilities are crucial for future preventive actions.

Amendment 486

Andreas Glück, Peter Liese

Proposal for a regulation

Recital 138

Text proposed by the Commission

Amendment

(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 and the information available in the European Medicines Verifications System (EMVS). 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 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. 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 patient 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.

_________________

Or. en

Justification

Data on the flow of medicinal products are available at large scale in the European Medicines Verifications System (EMVS). This data should be used as well in order to monitor shortages within the Union.

Amendment 487

Tilly Metz

Proposal for a regulation

Recital 138 a (new)

Text proposed by the Commission

Amendment

(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

Or. en

Amendment 488

Catherine Amalric, Max Orville, Billy Kelleher, Frédérique Ries, Andreas Glück, Dacian Cioloş

Proposal for a regulation

Recital 138 a (new)

Text proposed by the Commission

Amendment

(138 a) In addition to existing and planned policy, legislative and regulatory measures, the Union need a strategic and coordinated industrial approach to ensure the security of supply of the most critical medicines. The Critical Medicines Alliance and the future Critical Medicines Act could allow national authorities, industry, civil society representatives, the Commission and the EU agencies to develop together coordinated actions at Union level against the shortages of medicines, in compliance with the competition rules and the Union’s international commitments. The future Critical Medicines Act could support the European green, digital manufacturing of critical medicines, APIs and intermediate ingredients, diversify the EU pharmaceutical supply chains and secure the strategic autonomy of critical medicines.

Or. en

Amendment 489

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Billy Kelleher, Dacian Cioloş

Proposal for a regulation

Recital 138 a (new)

Text proposed by the Commission

Amendment

(138 a) To avoid that measures foreseen or taken by a Member State to prevent or mitigate a shortage at national level when responding to the legitimate needs of its citizen increase the risk of shortages in another Member State, the Agency should assess those measures with regards to their potential or actual impact on the availability and security of supply in other Member States and at European level, and inform of its assessment the Member States and the MSSG.

Or. en

Amendment 490

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Billy Kelleher, Dacian Cioloş

Proposal for a regulation

Recital 138 b (new)

Text proposed by the Commission

Amendment

(138 b) One of the aims of this Regulation is to set out a framework for the activities to be deployed by the Member States and the Agency to improve the Union's capacity to react efficiently and in a coordinated manner to support shortage management and security of supply of medicinal products, in particular critical medicinal products, to EU citizens, at all times. Those shortages are a persistent problem that has been increasingly affecting the health and lives of Union citizens for decades and the root causes are multifactorial. Therefore, this Regulation should be a first step towards improving the Union response to that persistent problem. The Commission should subsequently expand that framework to continue addressing the causes of shortages of medicinal products, and better prevent and mitigate their effects.

Or. en

Amendment 491

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Andreas Glück, Billy Kelleher, Dacian Cioloş

Proposal for a regulation

Recital 138 c (new)

Text proposed by the Commission

Amendment

(138 c) To complement this Regulation and as a first step to a more structural, long term approach to reduce Union dependencies for critical medicines and ingredients, particularly for products where there are only a few supplying manufacturers or countries, the Commission should propose by (OP: 24 months after the date of entry into force of this Regulation) a legislative initiative for an EU Critical Medicines Act for supporting the European green, digital manufacturing of key medicines, active pharmaceutical ingredients, and intermediate pharmaceutical ingredients for which the Union is dependent on one country or a limited number of manufacturers.

Or. en

Justification

This echoes the call launched in May 2023 by 19 Member States under Belgian coordination for an EU Critical Medicines Act. Available at https://www.rijksoverheid.nl/binaries/rijksoverheid/documenten/publicaties/2023/04/28/iz-1048167-b-311-non-paper-security-of-medicines-supply-280423/iz-1048167-b-311-non-paper-security-of-medicines-supply-280423.pdf

Amendment 492

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Billy Kelleher, Dacian Cioloş

Proposal for a regulation

Recital 138 d (new)

Text proposed by the Commission

Amendment

(138 d) It is appropriate for the Commission to build upon the Communication addressing medicine shortages in the European Union of 24 October 2023 and the many tools which can be used to promote a coordinated industrial approach, bringing together public and private actors from the European health and industrial ecosystem.

Or. en

Amendment 493

Nathalie Colin-Oesterlé

Proposal for a regulation

Recital 139 a (new)

Text proposed by the Commission

Amendment

(139a) The list of critical medicinal products drawn up at Union level should harmonise existing national lists and should not create confusion for the different actors in the pharmaceutical sector.

Or. fr

Amendment 494

Nathalie Colin-Oesterlé

Proposal for a regulation

Recital 139 b (new)

Text proposed by the Commission

Amendment

(139b) The creation of one of more non-profit pharmaceutical undertakings capable of producing certain medicines of health and strategic interest (MHSI) whose situation is critical or which are no longer profitable for pharmaceutical firms should complement and guarantee security of supply and prevent possible shortages of critical medicinal products.

Or. fr

Amendment 495

Nathalie Colin-Oesterlé

Proposal for a regulation

Recital 139 c (new)

Text proposed by the Commission

Amendment

(139c) Policies on the pricing of pharmaceutical products which only contain expenditure have a negative effect on the reliability of supply. The competent authorities of the Member States should be able to recommend an increase in the prices of products for which a risk of shortages or market consolidation has been identified.

Or. fr

Amendment 496

Nathalie Colin-Oesterlé

Proposal for a regulation

Recital 139 d (new)

Text proposed by the Commission

Amendment

(139d) The Covid-19 pandemic showed that introducing temporary regulatory flexibility measures in the event of a public health emergency can help tackle shortages of medicinal products.

Or. fr

Amendment 497

Nathalie Colin-Oesterlé

Proposal for a regulation

Recital 139 e (new)

Text proposed by the Commission

Amendment

(139e) Pharmaceutical firms operate according to the just-in-time method, which can leave manufacturers vulnerable to supply shocks where there are unanticipated production and supply chain interruptions and fluctuations in market demand.

Or. fr

Amendment 498

Nathalie Colin-Oesterlé

Proposal for a regulation

Recital 139 f (new)

Text proposed by the Commission

Amendment

(139f) Public procurement procedures can be an effective tool for tackling shortages of medicinal products. At Member State level, invitations to tender based solely on price and where there is only one bidder increase the risk of shortages of medicinal products by strongly eroding prices, reducing the number of suppliers on the market. At Union level, joint procurement should be recognised as a tool to tackle critical shortages, in particular during a health crisis, as demonstrated by the Covid-19 pandemic.

Or. fr

Amendment 499

Stanislav Polčák

Proposal for a regulation

Recital 140

Text proposed by the Commission

Amendment

(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. Regulation (EC) No 1049/2001 of the European Parliament and of the Council57gives 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.

(140) It is recognised that improved access to information contributes to public awareness and increases public trust, 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. Regulation (EC) No 1049/2001[1] of the European Parliament and of the Council 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. [1] 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).

_________________

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).

Or. cs

Amendment 500

Tilly Metz

Proposal for a regulation

Recital 140

Text proposed by the Commission

Amendment

(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. 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.

(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. 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.

_________________

Or. en

Justification

deleted sentence as too vague and not necessary as explained better in the following sentence

Amendment 501

Tilly Metz

Proposal for a regulation

Recital 141

Text proposed by the Commission

Amendment

(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 product but the economic entity involved.

(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, the 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 authority should be able to fine the entity with fines for each day of delay, which shall be transparent and proportionate.

Or. en

Amendment 502

Andrey Slabakov

Proposal for a regulation

Recital 141

Text proposed by the Commission

Amendment

(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 appropriate and adequate 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 product but the economic entity involved.

Or. en

Amendment 503

Stanislav Polčák

Proposal for a regulation

Recital 141

Text proposed by the Commission

Amendment

(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 penalties, which 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 product but the economic entity involved.

Or. cs

Amendment 504

Tilly Metz

Proposal for a regulation

Recital 143

Text proposed by the Commission

Amendment

(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.

(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 establishing and modifying decisions on the regulatory status of medicinal products should be exercised in accordance with Regulation (EU) 182/2011

Or. en

Amendment 505

Frédérique Ries, Catherine Amalric, Max Orville, Billy Kelleher

Proposal for a regulation

Recital 143

Text proposed by the Commission

Amendment

(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, establishing and modifying regulatory sandboxes and decisions on the regulatory status of medicinal products should be exercised in accordance with Regulation (EU) 182/2011.

Or. en

Amendment 506

Catherine Amalric, Max Orville

Proposal for a regulation

Recital 143

Text proposed by the Commission

Amendment

(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, establishing and modifying regulatory sandboxes and decisions on the regulatory status of medicinal products should be exercised in accordance with Regulation (EU) 182/2011.

Or. en

Amendment 507

Susana Solís Pérez, Ondřej Knotek

Proposal for a regulation

Recital 145

Text proposed by the Commission

Amendment

(145) Experience shows that, in clinical trials with investigational medicinal products containing or consisting of GMOs, the procedure to achieve compliance with the requirements of Directives 2001/18/EC and 2009/41/EC as regards the environmental risk assessment and consent by the competent authority of a Member State is complex and can take a significant amount of time.

(145) Experience shows that, in clinical trials with investigational medicinal products containing or consisting of GMOs, including some advanced therapy medicinal products, the procedure to achieve compliance with the requirements of Directives 2001/18/EC and 2009/41/EC as regards the environmental risk assessment and consent by the competent authority of a Member State is complex and can take a significant amount of time.

Or. en

Amendment 508

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Ondřej Knotek, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Recital 145

Text proposed by the Commission

Amendment

Or. en

Amendment 509

Stelios Kympouropoulos

Proposal for a regulation

Recital 145

Text proposed by the Commission

Amendment

(145) Experience shows that, in clinical trials with investigational medicinal products containing or consisting of GMOs, including some ATMPs, the procedure to achieve compliance with the requirements of Directives 2001/18/EC and 2009/41/EC as regards the environmental risk assessment and consent by the competent authority of a Member State is complex and can take a significant amount of time.

Or. en

Amendment 510

Anders Vistisen

on behalf of the ID Group

Aurélia Beigneux

Proposal for a regulation

Recital 149

Text proposed by the Commission

Amendment

(149) It is therefore appropriate to envisage a centralised assessment of the ERA involving experts from the national competent authorities.

(149) It is therefore appropriate to envisage a centralised assessment of the ERA involving experts from the national competent authorities before and establish a science- and risk-based approach.

Or. en

Amendment 511

Tilly Metz

Proposal for a regulation

Recital 149

Text proposed by the Commission

Amendment

(149) It is therefore appropriate to envisage a centralised assessment of the ERA involving experts from the national competent authorities.

(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.

Or. en

Amendment 512

Stanislav Polčák

Proposal for a regulation

Recital 154

Text proposed by the Commission

Amendment

(154) This Regulation is based on the double legal basis of Article 114 and Article 168(4), point (c), TFEU. It aims at achieving an internal market as regards medicinal products for human use, taking as a base a high level of protection of health. At the same time, this Regulation sets high standards of quality and safety for medicinal products in order to meet common safety concerns as regards these products. Both objectives are being pursued simultaneously. These two objectives are inseparably linked and one is not secondary to another. Regarding Article 114 TFEU, this Regulation establishes a European Medicines Agency and provides specific provision with regard to the central authorisation of medicinal products, therefore ensuring the functioning of the internal market and the free movement of medicinal products. Regarding Article 168(4), point (c), TFEU, this Regulation sets high standards of quality and safety for medicinal products.

(154) This Regulation is based on the double legal basis of Article 114 and Article 168(4), point (c), TFEU. It aims at achieving an internal market as regards medicinal products for human use, taking as a base a high level of protection of health. At the same time, this Regulation sets high standards of quality and safety for medicinal products in order to meet common safety concerns as regards these products. Both objectives are being pursued simultaneously. These two objectives are inseparably linked and one is not secondary to another. Regarding Article 114 TFEU, this Regulation regulates the functioning of the European Medicines Agency, established by Regulation (EC) No 726/2004, and provides specific provision with regard to the central authorisation of medicinal products, therefore ensuring the functioning of the internal market and the free movement of medicinal products. Regarding Article 168(4), point (c), TFEU, this Regulation sets high standards of quality and safety for medicinal products.

Or. cs

Amendment 513

Maria Angela Danzì

Proposal for a regulation

Recital 155

Text proposed by the Commission

Amendment

(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. To this end, specific actions will be established to reduce the gap between paediatric medicinal products, including speeding up the development and marketing of paediatric medicinal products, providing funds for paediatric research and setting which paediatric medicinal products are a priority with a view to covering unmet needs.

Or. it

Justification

Children's rights seem to be only partially recognised in the proposal. The establishment of a paediatric working group with a view to maintaining the PDCO's role in the sector, reviewing the provision of funds for research, reviewing the identification and definition of unmet therapeutic needs, etc.

Amendment 514

Tilly Metz

Proposal for a regulation

Recital 155

Text proposed by the Commission

Amendment

(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.

Or. en

Amendment 515

Maria Angela Danzì

Proposal for a regulation

Recital 156

Text proposed by the Commission

Amendment

(156) The objective of this Regulation is to ensure the authorisation of high quality medicinal products, including for paediatric patients and patients suffering from rare diseases throughout the Union. Where this objective cannot be sufficiently achieved by the Member States but can rather, by reason of its scale, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.

(156) The objective of this Regulation is to ensure the authorisation of high quality medicinal products, including for paediatric patients and patients suffering from rare diseases throughout the Union. Where this objective cannot be sufficiently achieved by the Member States, such as in the case of the development of paediatric medicinal products, but can rather, by reason of its scale, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.

Or. it

Justification

As is well known and highlighted in the paediatric regulation, the Member States cannot sufficiently improve the availability of medicines tested for paediatric use. It seems appropriate to provide for special measures at EU level on the basis of the principle of subsidiarity.

Amendment 516

Cyrus Engerer

Proposal for a regulation

Article 1 – paragraph 1

Text proposed by the Commission

Amendment

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 and other relevant Union legal acts.

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 monitoring and managamenet of shortages and critical shortages and 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 and other relevant Union legal acts.

Or. en

Amendment 517

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Billy Kelleher, Dacian Cioloş

Proposal for a regulation

Article 1 – paragraph 1

Text proposed by the Commission

Amendment

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 monitoring and management of shortages and critical shortages and 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 and other relevant Union legal acts.

Or. en

Amendment 518

Tilly Metz

Proposal for a regulation

Article 1 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 519

Nathalie Colin-Oesterlé

Proposal for a regulation

Article premier – paragraph 1

Text proposed by the Commission

Amendment

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 tackling shortages and 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 and other relevant Union legal acts.

Or. fr

Amendment 520

Stanislav Polčák

Proposal for a regulation

Article 1 – paragraph 1

Text proposed by the Commission

Amendment

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 rules on the governance and functioning 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 and other relevant Union legal acts.

Or. cs

Amendment 521

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Ondřej Knotek, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 2 – paragraph 2 – point 4

Text proposed by the Commission

Amendment

(4) ‘orphan medicine sponsor’ means any legal or natural person, established in the Union, who submitted an application for or has been granted an orphan designation by a decision referred to in Article 64(4);

(4) ‘orphan medicinal product sponsor’ means any legal or natural person, established in the Union, who submitted an application for or has been granted an orphan designation by a decision referred to in Article 64(4);

Or. en

Amendment 522

Andrey Slabakov, Elisabetta De Blasis

Proposal for a regulation

Article 2 – paragraph 2 – point 4

Text proposed by the Commission

Amendment

Or. en

Amendment 523

Tomislav Sokol

Proposal for a regulation

Article 2 – paragraph 2 – point 4

Text proposed by the Commission

Amendment

Or. en

Amendment 524

Fulvio Martusciello

Proposal for a regulation

Article 2 – paragraph 2 – point 4

Text proposed by the Commission

Amendment

Or. en

Amendment 525

Anders Vistisen

on behalf of the ID Group

Aurélia Beigneux

Proposal for a regulation

Article 2 – paragraph 2 – point 7

Text proposed by the Commission

Amendment

(7) ‘significant benefit’ means a clinically relevant advantage or a major contribution to patient care of an orphan medicinal product if such an advantage or contribution benefits a substantial part of the target population;

(7) ‘significant benefit’ means a clinically relevant advantage or a major contribution to patient care of an orphan medicinal product

Or. en

Amendment 526

Stelios Kympouropoulos, Pernille Weiss

Proposal for a regulation

Article 2 – paragraph 2 – point 7

Text proposed by the Commission

Amendment

(7) ‘significant benefit’ means a clinically relevant advantage or a major contribution to patient care of an orphan medicinal product;

Or. en

Amendment 527

Fulvio Martusciello

Proposal for a regulation

Article 2 – paragraph 2 – point 7

Text proposed by the Commission

Amendment

(7) ‘significant benefit’ means a clinically relevant advantage or a major contribution to patient care of an orphan medicinal product;

Or. en

Amendment 528

Massimiliano Salini, Francesca Peppucci

Proposal for a regulation

Article 2 – paragraph 2 – point 7

Text proposed by the Commission

Amendment

(7) ‘significant benefit’ means a clinically relevant advantage or a major contribution to patient care of an orphan medicinal product

Or. en

Amendment 529

Tomislav Sokol

Proposal for a regulation

Article 2 – paragraph 2 – point 7

Text proposed by the Commission

Amendment

Or. en

Amendment 530

Andrey Slabakov

Proposal for a regulation

Article 2 – paragraph 2 – point 7

Text proposed by the Commission

Amendment

Or. en

Amendment 531

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 2 – paragraph 2 – point 7 a (new)

Text proposed by the Commission

Amendment

(7 a) 'adverse reaction' means a response to a medicinal product that is noxious and unintended, and includes medication errors and uses outside of the terms of the marketing authorisation, including the misuse and abuse of the medication product;

Or. en

Justification

Necessary to ensure consistency in the reporting and recording of adverse reactions with National Competent Authorities and for the Eudravigilance database.

Amendment 532

Marian-Jean Marinescu

Proposal for a regulation

Article 2 – paragraph 2 – point 7 a (new)

Text proposed by the Commission

Amendment

(7 a) 'adverse reaction' means a response to a medical that is noxious and includes medication errors and uses outside of the terms of the marketing authorisation, including the misuse and abuse of the medication product;

Or. en

Justification

Adverse reaction is not defined in the regulation although the term is used throughout.

Amendment 533

István Ujhelyi

Proposal for a regulation

Article 2 – paragraph 2 – point 7 a (new)

Text proposed by the Commission

Amendment

(7 a) 'adverse reaction' means a response to a medical that is noxious and unintended and includes medication errors and uses outside of the terms of the marketing authorisation, including the misuse and abuse of the medication product;

Or. en

Amendment 534

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 2 – point 7 a (new)

Text proposed by the Commission

Amendment

(7 a) ‘adverse reaction’ means an effect on a person in response to a medicinal product that is noxious and unintended;

Or. en

Amendment 535

Tilly Metz

Proposal for a regulation

Article 2 – paragraph 2 – point 8 – point a

Text proposed by the Commission

Amendment

(a) greater efficacy than an authorised medicinal orphan medicinal product in a substantial part of the target population;

(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;

Or. en

Justification

Aligning with current definition of clinical superiority as laid down in the IA which will continue to apply: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2000:103:0005:0008:EN:PDF

Amendment 536

Tilly Metz

Proposal for a regulation

Article 2 – paragraph 2 – point 8 – point b

Text proposed by the Commission

Amendment

(b) greater safety than an authorised medicinal product in a substantial part of the target population;

(b) greater safety than an authorised medicinal product in a substantial part of the target population based on direct comparative trial;

Or. en

Amendment 537

Maria Angela Danzì

Proposal for a regulation

Article 2 – paragraph 2 – point 9 a (new)

Text proposed by the Commission

Amendment

(9a) 'Paediatric population' means the proportion of the population aged between infancy and 18.

Or. it

Justification

To emphasise its relevance, the definition of 'paediatric population' should be reinstated under the regulation.

Amendment 538

Maria Angela Danzì

Proposal for a regulation

Article 2 – paragraph 2 – point 9 b (new)

Text proposed by the Commission

Amendment

(9b) 'Paediatric investigation plan' means a research and development programme designed to ensure that the requisite data are generated determining the conditions in which a medicinal product may be authorised to treat the paediatric population;

Or. it

Justification

Stressing the importance of the paediatric investigation plan as the main tool to promote the development of paediatric medicine in all age groups. Its definition should be reintegrated into the regulation.

Amendment 539

Maria Angela Danzì

Proposal for a regulation

Article 2 – paragraph 2 – point 9 c (new)

Text proposed by the Commission

Amendment

(9c) 'Medicinal product authorised for a paediatric indication' means a medicinal product authorised for use in all or part of the paediatric population and for which the details of the indication authorised are specified in the summary of product characteristics drawn up in accordance with Article 4 of the [revised directive];

Or. it

Justification

This definition clarifies what a paediatric medicinal product is and the need to include details of the approved indication/dosage/formulation in the summary of product characteristics. This clarification is also intended to prevent confusion with the PUMA definition concerning the type of marketing authorisation, not the product itself.

Amendment 540

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 2 – point 10

Text proposed by the Commission

Amendment

(10) ‘regulatory sandbox’ means a regulatory framework during which it is possible to develop, validate and test in a controlled environment innovative or adapted regulatory solutions that facilitate the development and authorisation of innovative products which are likely to fall in the scope of this Regulation, pursuant to a specific plan and for a limited time under regulatory supervision.

deleted

Or. en

Amendment 541

Tilly Metz

Proposal for a regulation

Article 2 – paragraph 2 – point 10

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 542

Stelios Kympouropoulos

Proposal for a regulation

Article 2 – paragraph 2 – point 10

Text proposed by the Commission

Amendment

(10) ‘regulatory sandbox’ means a regulatory framework during which it is possible to develop, validate and test in a controlled environment innovative or adapted regulatory solutions, including, when applicable, the use of real-world evidence, in silico methods, digital twin, and AI, that facilitate the development and authorisation of innovative products which can be regulated as medicinal products or other categories of products, pursuant to a specific plan and for a limited time under regulatory supervision.

Or. en

Justification

Regulatory sandboxes offer a structured framework experimentation and advancement of regulation via proactive regulatory learning. Including real-world evidence, in silico methods and AI in the definition of regulatory sandboxes is important to leverage its potential in supporting regulatory risk assessment.

Amendment 543

Pernille Weiss

Proposal for a regulation

Article 2 – paragraph 2 – point 10

Text proposed by the Commission

Amendment

(10) ‘regulatory sandbox’ means a regulatory framework during which it is possible to develop, validate and test in a controlled environment innovative or adapted regulatory solutions that facilitate the development and authorisation of innovative products, pursuant to a specific plan and for a limited time under regulatory supervision.

Or. en

Amendment 544

Fulvio Martusciello

Proposal for a regulation

Article 2 – paragraph 2 – point 10

Text proposed by the Commission

Amendment

(10) ‘regulatory sandbox’ means a regulatory framework during which it is possible to develop, validate and test in a controlled environment innovative or adapted regulatory solutions that facilitate the development and authorisation of innovative products which might be regulated as medicinal products or other categories of products pursuant to a specific plan and for a limited time under regulatory supervision.

Or. en

Amendment 545

Tomislav Sokol

Proposal for a regulation

Article 2 – paragraph 2 – point 10

Text proposed by the Commission

Amendment

(10) ‘regulatory sandbox’ means a regulatory framework during which it is possible to develop, validate and test in a controlled environment innovative or adapted regulatory solutions that facilitate the development and authorisation of innovative products which might be regulated as medicinal products or other categories of products pursuant to a specific plan and for a limited time under regulatory supervision.

Or. en

Amendment 546

Kateřina Konečná

Proposal for a regulation

Article 2 – paragraph 2 – point 11

Text proposed by the Commission

Amendment

(11) ‘critical medicinal product’ means a medicinal product for which insufficient supply results in serious harm or risk of serious harm to patients and identified using the methodology pursuant to Article 130(1), point (a).

(11) ‘critical medicinal product’ means a medicinal product for which insufficient supply results in serious harm or risk of serious harm to patients or does not allow to satisfy priority health care needs of the population, and identified using the methodology pursuant to Article 130(1), point (a).

Or. en

Justification

Limiting ‘critical medicines’ to situations whereby insufficient supply would result in ‘serious harm’ to the patient is quite restrictive, as it could potentially leave out of the list medicines that are considered essential and frequently used, such as analgesics for mild to moderate pain.

Amendment 547

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 2 – paragraph 2 – point 11

Text proposed by the Commission

Amendment

(11) ‘critical medicinal product’ means a medicinal product for which insufficient supply results in serious harm or risk of serious harm to patients in the short or medium term and which has been identified using the methodology pursuant to Article 130(1), point (a).

Or. fr

Amendment 548

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 2 – paragraph 2 – point 11 a (new)

Text proposed by the Commission

Amendment

(11a) ‘medicine of health and strategic interest’ (MHSI) means a medicinal product for which an interruption in treatment poses an immediate danger to the life of the patient.

Or. fr

Amendment 549

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Ondřej Knotek, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 2 – paragraph 2 – point 11 a (new)

Text proposed by the Commission

Amendment

(11 a) ‘demand’ means the request for a medicinal product or a medical device by a healthcare professional or patient in response to clinical need; the demand is satisfactorily met when the medicinal product or the medical device is acquired in appropriate time and in sufficient quantity to allow continuity of the best care of patients;

Or. en

Justification

Definition adopted in the Extension of the Mandate of the European Medicines Agency

Amendment 550

Catherine Amalric, Max Orville, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 2 – paragraph 2 – point 11 a (new)

Text proposed by the Commission

Amendment

Or. en

Amendment 551

Kateřina Konečná

Proposal for a regulation

Article 2 – paragraph 2 – point 11 a (new)

Text proposed by the Commission

Amendment

Or. en

Amendment 552

Cyrus Engerer

Proposal for a regulation

Article 2 – paragraph 2 – point 11 a (new)

Text proposed by the Commission

Amendment

(11 a) 'demand' means the request for a medicinal product by a healthcare or patient in response to clinical need; the demand is satisfactorily met when the medicinal products is acequired in appropriate time and in sufficient quantity to allow continuity of provision of the best care to patients. Wholesalers are usually a key supply link between market authorization holders and the users of medicines, and in those cases, in order to estimate demand, the quantity requested in wholesale orders should be considered;

Or. en

Amendment 553

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 2 – point 11 a (new)

Text proposed by the Commission

Amendment

(11 a) ‘demand’ means the request for a medicinal product by a healthcare professional or patient in response to clinical need; the demand is satisfactorily met when the medicinal product is acquired in appropriate time and in sufficient quantity to allow continuity of provision of the best care to patients; Wholesalers are usually a key supply link between MAHs and the users of medicines, and in those cases, in order to estimate demand, the quantity requested in wholesale orders should be considered;

Or. en

Amendment 554

Andrey Slabakov

Proposal for a regulation

Article 2 – paragraph 2 – point 11 a (new)

Text proposed by the Commission

Amendment

(11 a) 'demand' means the request for a medicinal product by a healthcare professional or patient in response to a clinical need; the demand is satisfactorily met when the medicinal product is acquired in appropriate time and in sufficient quantity to allow continuity of the care of patients;

Or. en

Amendment 555

Tomislav Sokol

Proposal for a regulation

Article 2 – paragraph 2 – point 11 a (new)

Text proposed by the Commission

Amendment

Or. en

Amendment 556

Margarita de la Pisa Carrión

Proposal for a regulation

Article 2 – paragraph 2 – point 11 a (new)

Text proposed by the Commission

Amendment

(11 a) ‘demand’ means the request for a medicinal product by a healthcare professional or patient in response to clinical need; the demand is satisfactorily met when the medicinal product is acquired in appropriate time and in sufficient quantity and quality to allow the continuous fulfillment of the needs of the patients in the member state in question.

Or. en

Justification

Regulation (EU) 2022/123 of 25 January 2022 on a reinforced rolefor the European Medicines Agency in crisis preparedness andmanagement for medicinal products and medical devices providesfor a more exhaustive definition of ‘Shortage’ including areference to ‘Supply’ and ‘Demand’. In order to ensure aconsistent and workable definition of medicine shortage in allMember States it is essential that the definitions of shortage,supply and demand be similar in both Regulations to enable dataexchange and comparison.Demand must acknowledge the importance of finding sufficientand quality medical products that ensure that medical need iscovered safely.

Amendment 557

Andrey Slabakov, Elisabetta De Blasis

Proposal for a regulation

Article 2 – paragraph 2 – point 12

Text proposed by the Commission

Amendment

(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.

Or. en

Amendment 558

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 2 – paragraph 2 – point 12

Text proposed by the Commission

Amendment

(12) ‘shortage’ means a situation in which the supply, as defined by Regulation 2022/1231 b, of a medicinal product that is authorised and placed on the market in a Member State does not meet the demand, as defined by Regulation 2022/123, for that medicinal product in that Member State, whatever the cause.

_________________

1 b 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).

Or. fr

Amendment 559

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Ondřej Knotek, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 2 – paragraph 2 – point 12

Text proposed by the Commission

Amendment

(12) ‘shortage’ means a situation in which the supply of a medicinal product authorised and placed on the market in a Member State or of a CE-marked medical device does not meet demand for that medicinal product or medical device at a national level, whatever the cause

Or. en

Amendment 560

Catherine Amalric, Max Orville, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 2 – paragraph 2 – point 12

Text proposed by the Commission

Amendment

(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 or of a CE-marked medical device does not meet the demand for that medicinal product or medical device in that Member State, whatever the cause.

Or. en

Amendment 561

István Ujhelyi

Proposal for a regulation

Article 2 – paragraph 2 – point 12

Text proposed by the Commission

Amendment

(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 needs of patients’ demand for that medicinal product in that Member State, whatever the cause.

Or. en

Amendment 562

Tilly Metz

Proposal for a regulation

Article 2 – paragraph 2 – point 12

Text proposed by the Commission

Amendment

Or. en

Justification

As was the EP’s key priority in the EMA Mandate regulation, we shall keep the ‘whatever the cause’ in this definition, as we did in Regulation 2022/123, for consistency

Amendment 563

Kateřina Konečná

Proposal for a regulation

Article 2 – paragraph 2 – point 12

Text proposed by the Commission

Amendment

Or. en

Amendment 564

Frédérique Ries, Susana Solís Pérez, Max Orville, Ondřej Knotek, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 2 – paragraph 2 – point 12 a (new)

Text proposed by the Commission

Amendment

(12 a) ‘supply’ means the total volume of stock of a given medicinal product or medical device that is placed on the market by a marketing authorisation holder or a manufacturer;

Or. en

Justification

Definition adopted in the Extension of the mandate of the European Medicines Agency.

Amendment 565

Catherine Amalric, Max Orville, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 2 – paragraph 2 – point 12 a (new)

Text proposed by the Commission

Amendment

(12 a) ‘supply’ means the total volume of stock of a given medicinal product or medical device that is placed on the market by a marketing authorisation holder or a manufacturer;

Or. en

Amendment 566

Kateřina Konečná

Proposal for a regulation

Article 2 – paragraph 2 – point 12 a (new)

Text proposed by the Commission

Amendment

(12 a) ‘supply’ means the total volume of stock of a given medicinal product that is placed on the market by a marketing authorisation holder or a manufacturer;

Or. en

Amendment 567

Tomislav Sokol

Proposal for a regulation

Article 2 – paragraph 2 – point 12 a (new)

Text proposed by the Commission

Amendment

(12 a) ‘supply’ means the total volume of stock of a given medicinal product that is placed on the market by a marketing authorization holder or a manufacturer.

Or. en

Amendment 568

Andrey Slabakov, Elisabetta De Blasis

Proposal for a regulation

Article 2 – paragraph 2 – point 12 a (new)

Text proposed by the Commission

Amendment

(12 a) 'supply' means the total volume of stock of a given medicinal product or medical device that is placed on the market by a marketing authorisation holder or a manufacturer;

Or. en

Amendment 569

Margarita de la Pisa Carrión

Proposal for a regulation

Article 2 – paragraph 2 – point 12 a (new)

Text proposed by the Commission

Amendment

(12 a) ‘Supply’ means the total volume of stock of a given medicinal product that is placed on the market by a marketing authorization holder or a manufacturer.

Or. en

Justification

Amendment 570

Cyrus Engerer

Proposal for a regulation

Article 2 – paragraph 2 – point 13

Text proposed by the Commission

Amendment

(13) ‘critical shortage in the Member State’ means a shortage of a medicinal product, for which there is no appropriate alternative medicinal product available on the market in that Member State, and that shortage cannot be resolved.

(13) ‘critical shortage in the Member State’ means a shortage of a medicinal product, for which there is no therapeutical alternative medicinal product available on the market in that Member State, and that shortage cannot be resolved.

Or. en

Amendment 571

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 2 – point 13

Text proposed by the Commission

Amendment

(13) ‘critical shortage in the Member State’ means a shortage of a medicinal product, for which there is no appropriate therapeutical alternative available on the market in that Member State, and that shortage cannot be resolved.

Or. en

Amendment 572

Catherine Amalric, Max Orville, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 2 – paragraph 2 – point 14 a (new)

Text proposed by the Commission

Amendment

(14 a) 'Healthcare professionals’ organisations’ means not-for-profit organisations that have an interest in patient care, and where healthcare professionals represent a majority of members in governing bodies.

Or. en

Amendment 573

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 2 – point 14 a (new)

Text proposed by the Commission

Amendment

(14 a) ‘clock stops’ means a period of time during which the evaluation of a medicine is officially stopped, while the applicant prepares responses to questions from the regulatory authority. The clock resumes when the applicant has sent its responses.

Or. en

Amendment 574

Catherine Amalric, Max Orville, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 2 – paragraph 2 – point 14 b (new)

Text proposed by the Commission

Amendment

(14 b) ‘Patients’ organisations’ means as not-for-profit organisations which are patient focused, and where patients and/or carers (the latter when patients are unable to represent themselves) represent a majority of members in governing bodies.

Or. en

Amendment 575

Cyrus Engerer

Proposal for a regulation

Article 2 – paragraph 2 – point 14 a (new)

Text proposed by the Commission

Amendment

(14 a) 'unavailability’ means a situation a product has not been launched, has been permanently withdrawn or marketing has been ceased or suspended.

Or. en

Amendment 576

Tiemo Wölken

Proposal for a regulation

Article 3 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) the applicant shows that the medicinal product constitutes a significant therapeutic, scientific or technical innovation or that the granting of marketing authorisation in accordance with this Regulation is in the interest of patients' health at Union level, including as regards antimicrobial resistance and medicinal products for public health emergencies;

Or. en

Amendment 577

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Billy Kelleher

Proposal for a regulation

Article 4 – title

Text proposed by the Commission

Amendment

Member State authorisation of generics of centrally authorised medicinal products

Member State authorisation of specific categories of medicinal products

Or. en

Amendment 578

Dolors Montserrat

Proposal for a regulation

Article 4 – title

Text proposed by the Commission

Amendment

Member State authorisation of generics of centrally authorised medicinal products

Member State authorisation of certain categories of medicinal products

Or. en

Amendment 579

Andrey Slabakov

Proposal for a regulation

Article 4 – title

Text proposed by the Commission

Amendment

Member State authorisation of generics of centrally authorised medicinal products

Member State authorisation of certain categories of medicinal products

Or. en

Amendment 580

Andrey Slabakov

Proposal for a regulation

Article 4 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

A generic medicinal product of a reference medicinal product authorised by the Union may be authorised by the competent authorities of the Member States in accordance with [revised Directive 2001/83/EC] under the following conditions:

A medicinal product may be authorised by the competent authorities of the Member States in accordance with [revised Directive 2001/83/EC] under the following conditions:

Or. en

Amendment 581

Dolors Montserrat

Proposal for a regulation

Article 4 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

A medicinal product may be authorised by the competent authorities of the Member States in accordance with [revised Directive 2001/83/EC] under the following conditions:

Or. en

Amendment 582

Andrey Slabakov

Proposal for a regulation

Article 4 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) the application for marketing authorisation is submitted in accordance with Article 9 of [revised Directive 2001/83/EC];

(a) the application for marketing authorisation is submitted in accordance with Article 9, 10, 13 of [revised Directive 2001/83/EC], or for active substances used in fixed dose combination medicinal products that have previously been used in the composition of authorised medicinal products;

Or. en

Amendment 583

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Billy Kelleher

Proposal for a regulation

Article 4 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) the application for marketing authorisation is submitted in accordance with Article 9 of [revised Directive 2001/83/EC];

Or. en

Amendment 584

Dolors Montserrat

Proposal for a regulation

Article 4 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) the application for marketing authorisation is submitted in accordance with Article 9 of [revised Directive 2001/83/EC];

(a) the application for marketing authorisation is submitted in accordance with Article 9, 10, 13 of [revised Directive 2001/83/EC] or for active substances used in fixed dose combination medicinal products that have previously been used in the composition of authorised medicinal products;

Or. en

Amendment 585

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Billy Kelleher

Proposal for a regulation

Article 4 – paragraph 2

Text proposed by the Commission

Amendment

Point (b), first subparagraph, shall not apply to those parts of summary of product characteristics and package leaflet referring to indications, posologies, pharmaceutical forms, methods or routes of administration or any other way in which the medicinal product may be used which were still covered by a patent or a supplementary protection certificate for medicinal products at the time when the generic medicinal product was marketed and where the applicant for the generic medicinal product has requested not to include this information in their marketing authorisation.

Point (b), first subparagraph, shall not apply to those parts of summary of product characteristics and package leaflet referring to indications, posologies, pharmaceutical forms, methods or routes of administration or any other way in which the medicinal product may be used which were still covered by a patent or a supplementary protection certificate for medicinal products at the time when the medicinal product was marketed and where the applicant for the medicinal product has requested not to include this information in their marketing authorisation.

Or. en

Amendment 586

Dolors Montserrat

Proposal for a regulation

Article 4 – paragraph 2

Text proposed by the Commission

Amendment

Point (b), first subparagraph, shall not apply to those parts of summary of product characteristics and package leaflet referring to indications, posologies, pharmaceutical forms, methods or routes of administration or any other way in which the medicinal product may be used which were still covered by a patent or a supplementary protection certificate for medicinal products at the time when the medicinal product was marketed and where the applicant for the medicinal product has requested not to include this information in their marketing authorisation.

Or. en

Amendment 587

Andrey Slabakov

Proposal for a regulation

Article 4 – paragraph 2

Text proposed by the Commission

Amendment

Point (b), first subparagraph, shall not apply to those parts of summary of product characteristics and package leaflet referring to indications, posologies, pharmaceutical forms, methods or routes of administration or any other way in which the medicinal product may be used which were still covered by a patent or a supplementary protection certificate for medicinal products at the time when the medicinal product was marketed and where the applicant for the medicinal product has requested not to include this information in their marketing authorisation.

Or. en

Amendment 588

Andrey Slabakov

Proposal for a regulation

Article 5 – paragraph 5

Text proposed by the Commission

Amendment

5. Within 20 days of receipt of an application, the Agency shall check whether all the information and documentation required in accordance with Article 6 have been submitted, that the application does not contain critical deficiencies that may prevent the evaluation of the medicinal product and decide whether the application is valid.

5. Within 20 days of receipt of an application, the Agency shall check whether all the information and documentation required in accordance with Article 6 have been submitted, that the application does not contain critical deficiencies as defined in guidelines established under paragraph 7 that may prevent the evaluation of the medicinal product and decide whether the application is valid.

Or. en

Amendment 589

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Billy Kelleher

Proposal for a regulation

Article 5 – paragraph 5

Text proposed by the Commission

Amendment

5. Within 20 days of receipt of an application, the Agency shall check whether all the information and documentation required in accordance with Article 6 have been submitted, that the application does not contain critical deficiencies as defined in guidelines established under paragraph 7 that may prevent the evaluation of the medicinal product and decide whether the application is valid.

Or. en

Amendment 590

Andrey Slabakov

Proposal for a regulation

Article 5 – paragraph 6 – subparagraph 3

Text proposed by the Commission

Amendment

If the applicant fails to provide the missing information and documentation within the time limit, the application shall be considered to have been withdrawn.

deleted

Or. en

Amendment 591

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Billy Kelleher

Proposal for a regulation

Article 6 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

The documentation shall include a 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.

(a) the use of additional qualifiers where necessary to identify different presentations of the medicinal product concerned.

(b) the use of identified versions of the summary of product characteristics as referred to in article 62 of [Revised Directive] in situations where elements of the product information are still covered by patent law or supplementary protection certificates for medicinal products.

(c) 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).

Or. en

Amendment 592

Tilly Metz

Proposal for a regulation

Article 6 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

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).

Or. en

Amendment 593

Tilly Metz

Proposal for a regulation

Article 6 – paragraph 1 – subparagraph 2 – point 1 (new)

Text proposed by the Commission

Amendment

(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.

Or. en

Justification

Comparative data should be the standard rather than the bonus already when it comes to authorisation of medicines, it would make it easier to then conduct HTA assessment and pricing and reimbursement decisions where this data is typically required, requiring comparative data would result in more robust evidence at the time of marketing authorisation and it would reduce duplication of clinical studies

Amendment 594

Tilly Metz

Proposal for a regulation

Article 6 – paragraph 1 – subparagraph 2 a (new)

Text proposed by the Commission

Amendment

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.

Or. en

Justification

In order to ensure medicines serve the need of patients, measuring patient experiences in clinical studies and reporting on them to regulators is crucial

Amendment 595

Margarita de la Pisa Carrión

Proposal for a regulation

Article 6 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

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 Union, 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.

For medicinal products that are likely to offer an exceptional therapeutic advancement or expected to be of major interest from the point of view of public health in the diagnosis in the diagnosis, 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, or upon request of the applicant offer to the applicant a phased review of complete data packages for individual modules of particulars and documentation as referred to in paragraph 1.

Or. en

Amendment 596

Tomislav Sokol

Proposal for a regulation

Article 6 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

For medicinal products that are likely to offer an exceptional therapeutic advancement in the diagnosis or expected to be of major interest from the point of view of public health, 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.

Or. en

Amendment 597

István Ujhelyi

Proposal for a regulation

Article 6 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

For medicinal products that are likely to offer an exceptional therapeutic advancement or are expected to be of major interest from the point of view of public health, the Agency may, following the advice of the Committee for Medicinal Products for Human Use regarding the maturity of the data or following a request of the applicant 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.

Or. en

Amendment 598

Tilly Metz

Proposal for a regulation

Article 6 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

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 conditions 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.

Or. en

Amendment 599

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Ondřej Knotek, Billy Kelleher, Erik Poulsen, Dacian Cioloş

Proposal for a regulation

Article 6 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

For medicinal products that are likely to offer an exceptional therapeutic advancement in the diagnosis, prevention or treatment, including with regard to the quality of life of a relevant patient population or subpopulation, of a life-threatening, seriously debilitating or serious and chronic condition in the Union, 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.

Or. en

Amendment 600

Ondřej Knotek, Frédérique Ries, Billy Kelleher

Proposal for a regulation

Article 6 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

For medicinal products that are likely to offer an exceptional therapeutic advancement in the diagnosis, prevention or treatment, including the improvement of quality of life of certain patient's groups, of a life-threatening, seriously debilitating or serious and chronic condition in the Union, 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.

Or. en

Amendment 601

Stelios Kympouropoulos

Proposal for a regulation

Article 6 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

For medicinal products that are likely to offer an exceptional therapeutic advancement or are expected to be of great interest for public health in the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition in the Union, 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.

Or. en

Amendment 602

Andreas Glück, Frédérique Ries, Catherine Amalric

Proposal for a regulation

Article 6 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

For orphan medicinal products and 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 Union, 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.

Or. en

Justification

The procedure of rolling reviews proved to be very valuable during the COVID-19 Pandemic. An extension to orphan medicinal products is appropriate as medicinal products should reach patients as fast as possible.

Amendment 603

Tiemo Wölken

Proposal for a regulation

Article 6 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

For medicinal products, during a public health emergency or to address a major event, that are likely to offer an exceptional therapeutic advancement in the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition in the Union, the Agency may, after the Commission has recognised a public health emergency at Union level in accordance with Article 23(1) of Regulation (EU) 2022/2371 and following the advice of the Committee for Medicinal Products for Human Use regarding the maturity of the data related to the development, offer to the applicant a phased review of complete data packages for individual modules of particulars and documentation as referred to in paragraph 1.

Or. en

Amendment 604

István Ujhelyi

Proposal for a regulation

Article 6 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

The Agency may at any stage suspend or cancel the phased review, where the Committee for Medicinal Products for Human Use considers that the submitted data are not of sufficient maturity or where it is considered that the medicinal product no longer fulfils an exceptional therapeutic advancement. The Agency shall inform the applicant accordingly.

The Agency may at any stage suspend or cancel the phased review, where the Committee for Medicinal Products for Human Use considers that the submitted data are not of sufficient maturity or where it is considered that the medicinal product no longer fulfils an exceptional therapeutic advancement or is no longer expected to be of major interest from the point of view of public health. The Agency shall inform the applicant accordingly.

Or. en

Amendment 605

Stelios Kympouropoulos

Proposal for a regulation

Article 6 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

The Agency may at any stage suspend or cancel the phased review, where the Committee for Medicinal Products for Human Use considers that the submitted data are not of sufficient maturity or where it is considered that the medicinal product no longer fulfils an exceptional therapeutic advancement or does no longer present great interest for public health. The Agency shall inform the applicant accordingly.

Or. en

Amendment 606

Tomislav Sokol

Proposal for a regulation

Article 6 – paragraph 4

Text proposed by the Commission

Amendment

4. Where appropriate, the application may include an active substance master file certificate or an application for an active substance master file or any other quality master file certificate or application as referred to in Article 25 of [revised Directive 2001/83/EC].

Or. en

Amendment 607

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 6 – paragraph 4

Text proposed by the Commission

Amendment

4. Where appropriate, the application may include an active substance master file certificate or an application for an active substance master file or any other master file certificate or application as referred to in Article 25 and Article 26 of [revised Directive 2001/83/EC].

Or. en

Amendment 608

Susana Solís Pérez, Frédérique Ries, Catherine Amalric

Proposal for a regulation

Article 6 – paragraph 5 – subparagraph 2

Text proposed by the Commission

Amendment

The marketing authorisation applicant shall not carry out animal tests in case scientifically satisfactory non-animal testing methods are available.

The marketing authorisation applicant shall not carry out animal tests in case scientifically satisfactory non-animal testing methods are available. When scientifically reliable non-animal testing alternatives are unavailable, applicants utilizing animal testing must adhere to the principles of replacement, reduction, and refinement of animal testing for scientific purposes. This adherence must be in accordance with Directive 2010/63/EU for any animal study carried out to support their application.

Or. en

Amendment 609

Tilly Metz

Proposal for a regulation

Article 6 – paragraph 5 – subparagraph 2

Text proposed by the Commission

Amendment

The marketing authorisation applicant shall not carry out animal tests in case scientifically satisfactory non-animal testing methods are available.

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.

Or. en

Amendment 610

Stanislav Polčák

Proposal for a regulation

Article 6 – paragraph 5 – subparagraph 2

Text proposed by the Commission

Amendment

The marketing authorisation applicant shall not carry out animal tests in case scientifically satisfactory non-animal testing methods are available.

The marketing authorisation applicant shall not carry out animal testing in case scientifically satisfactory non-animal testing methods are available, or where the results of animal studies previously carried out by the applicant or others may be used for the medicinal product.

Or. cs

Amendment 611

Maria Angela Danzì

Proposal for a regulation

Article 6 – paragraph 6 – subparagraph 1

Text proposed by the Commission

Amendment

The Agency shall ensure that the opinion of the Committee for Medicinal Products for Human Use is given within 180 days after receipt of a valid application. In the case of a medicinal product for human use containing or consisting of genetically modified organisms, the opinion of that Committee shall take into account the evaluation of the environmental risk assessment in accordance with Article 8.

The Agency shall ensure that the opinion of the Committee for Medicinal Products for Human Use is given within 150 days after receipt of a valid application. In the case of a medicinal product for human use containing or consisting of genetically modified organisms, the opinion of that Committee shall take into account the evaluation of the environmental risk assessment in accordance with Article 8.

Or. it

Amendment 612

Tiemo Wölken

Proposal for a regulation

Article 6 – paragraph 6 – subparagraph 1

Text proposed by the Commission

Amendment

The Agency shall ensure that the opinion of the Committee for Medicinal Products for Human Use is given within 180 days, excluding clock stops, after receipt of a valid application. In the case of a medicinal product for human use containing or consisting of genetically modified organisms, the opinion of that Committee shall take into account the evaluation of the environmental risk assessment in accordance with Article 8.

Or. en

Amendment 613

Tomislav Sokol

Proposal for a regulation

Article 6 – paragraph 6 – subparagraph 2

Text proposed by the Commission

Amendment

On the basis of a duly reasoned request, the Committee for Medicinal Products for Human Use may call for the duration of the analysis of the scientific data in the file concerning the application for marketing authorisation to be extended.

Or. en

Amendment 614

Tomislav Sokol

Proposal for a regulation

Article 6 – paragraph 7 – subparagraph 1

Text proposed by the Commission

Amendment

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 innovation, 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.

When an application is submitted for a marketing authorisation in respect of medicinal products for human use or new therapeutic indications when grouped with an extension of the marketing authorisation, which provide an exceptional therapeutic advancement or are of major interest from the point of view of public health and in particular from the viewpoint of therapeutic innovation, the applicant may request an accelerated assessment procedure. Products referred to in Article 6(2) and article 60 shall qualify for this process by default. The request shall be duly substantiated.

Or. en

Amendment 615

Tilly Metz

Proposal for a regulation

Article 6 – paragraph 7 – subparagraph 1

Text proposed by the Commission

Amendment

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 unmet 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.

Or. en

Amendment 616

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Andreas Glück, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 6 – paragraph 7 – subparagraph 2

Text proposed by the Commission

Amendment

If the Committee for Medicinal Products for Human Use accepts the request, the time-limit laid down in Article 6(6), first subparagraph, shall be reduced to 150 days.

If the Committee for Medicinal Products for Human Use accepts the request, the time-limit laid down in Article 6(6), first subparagraph, shall be reduced to 120 days.

Or. en

Amendment 617

Tomislav Sokol

Proposal for a regulation

Article 6 – paragraph 7 – subparagraph 2

Text proposed by the Commission

Amendment

If the Committee for Medicinal Products for Human Use accepts the request, the time-limit laid down in Article 6(6), first subparagraph, shall be reduced to 150 days.

If the Committee for Medicinal Products for Human Use accepts the request, the time-limit laid down in Article 6(6), first subparagraph, shall be reduced to 120 days.

Or. en

Amendment 618

Maria Angela Danzì

Proposal for a regulation

Article 6 – paragraph 7 – subparagraph 2

Text proposed by the Commission

Amendment

If the Committee for Medicinal Products for Human Use accepts the request, the time-limit laid down in Article 6(6), first subparagraph, shall be reduced to 150 days.

If the Committee for Medicinal Products for Human Use accepts the request, the time-limit laid down in Article 6(6), first subparagraph, shall be reduced to 120 days.

Or. it

Amendment 619

Maria Angela Danzì

Proposal for a regulation

Article 6 – paragraph 7 a (new)

Text proposed by the Commission

Amendment

7a. An application for a marketing authorisation submitted pursuant to this Regulation for a medicinal product for human use that has not been granted a paediatric derogation shall be considered valid only if it includes the results of all paediatric studies performed and other information collected in accordance with an agreed paediatric investigation plan, as laid down in Article 6 of the revised [Directive 2001/83/EC];

Or. it

Justification

The obligation introduced under the Paediatric Regulation to carry out paediatric studies, the results of which should be submitted at the time of the application for marketing authorisation for new or already patented/certified medicinal products, should be clearly identified as a key part of the centralised marketing authorisation process.

Amendment 620

Tomislav Sokol

Proposal for a regulation

Article 6 a (new)

Text proposed by the Commission

Amendment

Article6a

Parallel application

(1) During the scientific assessment of an initial marketing authorisation application of a medicinal product by the Agency, the applicant may submit to the Agency a separate parallel application for one or more new indications concerning the same medicinal product.

(2) The parallel application shall be assessed by the Agency as a marketing authorisation application in accordance with this Regulation, subject to the following:

a) to the extent the Committee for Medicinal Products for Human Use can assess the parallel application within the timeframe applicable to the initial marketing authorisation application, leading to the same outcome for both applications it shall group the applications and issue a single opinion.

b) to the extent the said Committee cannot issue an opinion on the parallel application within the timeframe applicable to the initial marketing authorisation application, the parallel application shall be converted to a Type II variation application.

c) if the initial marketing authorisation application is withdrawn or receives a negative opinion from the Committee for Medicinal Products for Human Use, the Committee will pursue the assessment of the parallel application as a standalone marketing authorisation application.

Or. en

Amendment 621

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Andreas Glück, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 6 a (new)

Text proposed by the Commission

Amendment

Article6a

Parallel application for one or more new indications

(2) The parallel application shall be assessed by the Agency as a marketing authorisation application in accordance with this Regulation, subject to the following:

(a) To the extent the Committee for Medicinal Products for Human Use can assess the parallel application within the timeframe applicable to the initial marketing authorisation application, leading to the same outcome for both applications it shall group the applications and issue a single opinion.

(b) To the extent the said Committee cannot issue an opinion on the parallel application within the timeframe applicable to the initial marketing authorisation application the parallel application shall be converted to a Type II variation application in accordance with Commission Regulation (EC) No 1234/2008.

(c) If the initial marketing authorisation application is withdrawn or receives a negative opinion from the Committee for Medicinal Products for Human Use, the Committee will pursue the assessment of the parallel application as a standalone marketing authorisation application.

Or. en

Amendment 622

Stanislav Polčák

Proposal for a regulation

Article 7 – paragraph 1

Text proposed by the Commission

Amendment

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 and the environment.

Or. cs

Amendment 623

Sara Cerdas

Proposal for a regulation

Article 7 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 624

Tilly Metz

Proposal for a regulation

Article 7 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 625

Stanislav Polčák

Proposal for a regulation

Article 7 – paragraph 4 – introductory part

Text proposed by the Commission

Amendment

4. Articles 6 to 11 of [revised Directive 2001/18/EC] as well as Articles 4 to 13 of Directive 2009/41/EC shall not apply to operations related to the supply and clinical use, including the packaging and labelling, distribution, storage, transport, preparation for administration, administration, destruction or disposal of medicinal products containing or consisting of genetically modified organisms, with the exception of their manufacture, in any of the following cases:

4. Articles 6 to 11 of [revised Directive 2001/83/EC] as well as Articles 4 to 13 of Directive 2009/41/EC shall not apply to operations related to the supply and clinical use, including the packaging and labelling, distribution, storage, transport, preparation for administration, administration, destruction or disposal of medicinal products containing or consisting of genetically modified organisms, with the exception of their manufacture, in any of the following cases:

Or. cs

Amendment 626

Stanislav Polčák

Proposal for a regulation

Article 7 – paragraph 5 – subparagraph 1

Text proposed by the Commission

Amendment

In the cases referred to in paragraph 4, Member States shall implement appropriate measures to minimise foreseeable negative environmental impacts resulting from the intended or unintended release of the medicinal products containing or consisting of genetically modified organisms into the environment.

In the cases referred to in paragraph 4, Member States shall implement appropriate measures based on the precautionary principle to minimise negative environmental impacts resulting from the intended or unintended release of the medicinal products containing or consisting of genetically modified organisms into the environment.

Or. cs

Amendment 627

Anders Vistisen

on behalf of the ID Group

Proposal for a regulation

Article 7 – paragraph 5 – subparagraph 2 a (new)

Text proposed by the Commission

Amendment

By derogation from this Article, where the marketing authorisation application concerns a medicinal product for human use containing or consisting of genetically modified organisms which comply with the criteria referred to in paragraph 3 of Article 5a of Regulation (EU) No 536/2014, Article 22 of [revised Directive 2001/83/EC] shall apply.

Or. en

Amendment 628

Anders Vistisen

on behalf of the ID Group

Proposal for a regulation

Article 7 – paragraph 5 – subparagraph 2 b (new)

Text proposed by the Commission

Amendment

No later than [note to OP = five years after the date of entry into application of this Regulation], the Commission shall conduct an impact assessment of the Union legislation on genetically modified organisms* on medicinal products containing or consisting of genetically modified organisms and produce an evaluation report, taking into account the experience gained from the application of this Regulation, [revised Directive 2001/83/EC], Regulation (EU) No 536/2014 and Regulation (EU) 2020/1043. On the basis of the impact assessment and evaluation, the Commission shall come forward with a legislative proposal to amend this Regulation and [revised Directive 2001/83/EC] to lay down specific rules on environmental risk assessments for medicines containing or consisting of genetically modified organisms outside the scope of the general Union legislation on genetically modified organisations.

Or. en

Amendment 629

Catherine Amalric

Proposal for a regulation

Article 8 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) identification and characterisation of hazards for the environment, animals and for human health;

(b) identification and characterisation of hazards for the environment, animals and for human health throughout the life cycle of the medicine, including during its production; these risks include those linked to the greenhouse gas emissions footprint;

Or. en

Amendment 630

Tilly Metz

Proposal for a regulation

Article 8 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) identification and characterisation of hazards for the environment, animals and for human health;

(b) identification and characterisation of hazards for the environment, animals and for human and public health;

Or. en

Amendment 631

Sara Cerdas

Proposal for a regulation

Article 8 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) risk minimisation strategies proposed to address identified risks including specific containment measures to limit contact with the medicinal product.

(e) risk minimisation and mitigation strategies proposed to address identified risks including specific containment measures to limit contact with the medicinal product, as well as any circular economy processes adopted.

Or. en