31 Amendments of István UJHELYI related to 2023/0131(COD)
Amendment 205 #
Proposal for a regulation
Recital 2
Recital 2
(2) The Pharmaceutical Strategy for Europe marks a turning point with the addition of further key objectives and by creatingaiming to create attractive environment for research, development and production of medicines in the Union, along with a modern framework that makes innovative and established medicinal products available to patients and healthcare systems at affordable prices, while ensuring security of supply and addressing environmental concerns.
Amendment 309 #
Proposal for a regulation
Recital 66
Recital 66
(66) Expedited Regulatory Pathways are a well-utilised tool to make assessments of pharmaceuticals more efficient and to modernise regulatory systems. Through the Priority Medicines (PRIME) scheme, the Agency has gained experience of the provision of early scientific and regulatory support to developers of certain medicinal products that, based on preliminary evidence, are likely to address an unmet medical need and are considered promising at an early stage of development. IGiven the objectives of this Regulation – to futureproof and simplify the European regulatory system, it is appropriate to recognise and strengthen this early support mechanism, including for priority antimicrobials and repurposed medicinal products when they fulfil the criteria for the scheme, and allow the Agency, in consultation with the Member States and the Commission, to establish selection criteria for promising medicinal products.
Amendment 320 #
Proposal for a regulation
Recital 73
Recital 73
(73) To optimise the use of resources for both applicants for marketing authorisations and competent authorities assessing such applications, a single assessment of an active substance master file should be introduced. The outcome of the assessment should be issued through a certificate. To avoid duplication of assessment, the use of an active substance master file certificate should be mandatory for subsequent applications or marketing authorisations for medicinal products for human use containing that active substance from an active substance master file certification holder. The Commission should be empowered to establish the procedure for the single assessment of an active substance master file. To further optimise the use of resources, the Commission should be empowered to extend the certification scheme to additional quality master files, e.g. in case of novel excipients, adjuvants, raw materials, viral vectors and other starting materials, growth media, radiopharmaceutical precursors and active substance intermediates, when the intermediate is a chemical active substance by itself or used in conjugation with a biological substance.
Amendment 390 #
Proposal for a regulation
Recital 88
Recital 88
(88) Regulation (EC) No 141/2000 of the European Parliament and of the Council55 has proved to be successful in boosting developments of orphan medicinal products in the European Union; therefore an action at Union level remains preferable to uncoordinated measures by the Member States which may result in distortions of competition and barriers to intra-Union trade. _________________ 55 Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ L 18, 22.1.2000, p. 1)EU trade. The Union should not neglect or disregard the success of the Regulation since its entry into force in 2000, and build on its success driving and ensuring a similar degree of innovation under this Regulation.
Amendment 400 #
Proposal for a regulation
Recital 92 a (new)
Recital 92 a (new)
(92 a) What constitutes significant benefit in a patient population can change over time, therefore, the concept should remain sufficiently flexible to ensure a future-proof regulatory framework while ensuring predictability through additional guidance.
Amendment 406 #
Proposal for a regulation
Recital 93
Recital 93
Amendment 417 #
Proposal for a regulation
Recital 102
Recital 102
(102) In order to incentiviseze investment and innovation, research and development of orphan medicinal products addressing high unes where either no other treatment 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, whileexists 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 medicinal productes, requiring less investment, is the shortest. In order to ensure increased predictability for developers, the possibility to review the eligibility criteria for market exclusivity after six years after the marketing authorisation has been abolished.
Amendment 461 #
Proposal for a regulation
Recital 134 a (new)
Recital 134 a (new)
(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.
Amendment 471 #
Proposal for a regulation
Recital 136
Recital 136
(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 of critical medicinal products 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.
Amendment 473 #
Proposal for a regulation
Recital 137
Recital 137
(137) To achieve a better security of supply for medicinal products in the internal market and to contribute thereby to a high level of public health protection, it is appropriate to approximate the rules on monitoring and reporting of actual or potential shortages of medicinal products, including the procedures and the respective roles and obligations of concerned entities in this Regulation. It is important to ensure continued supply of medicinal products, which is often taken for granted across Europe. This is especially true for the most critical medicinal products which are essential to ensure the continuity of care, the provision of quality healthcare and guarantee a high level of public health protection in Europe. To 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.
Amendment 533 #
Proposal for a regulation
Article 2 – paragraph 2 – point 7 a (new)
Article 2 – paragraph 2 – point 7 a (new)
(7 a) 'adverse reaction' means 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;
Amendment 561 #
Proposal for a regulation
Article 2 – paragraph 2 – point 12
Article 2 – paragraph 2 – point 12
(12) ‘shortage’ means a situation in which the supply of a medicinal product that is authorised and placed on the market in a Member State does not meet the needs of patients’ demand for that medicinal product in that Member State, whatever the cause.
Amendment 597 #
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1
Article 6 – paragraph 2 – subparagraph 1
For medicinal products that are likely to offer an exceptional therapeutic advancement in the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition in the Unionor 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.
Amendment 604 #
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 2
Article 6 – paragraph 2 – subparagraph 2
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.
Amendment 959 #
Proposal for a regulation
Article 48 – paragraph 1 – subparagraph 1
Article 48 – paragraph 1 – subparagraph 1
An entity not engaged in an economic activity (‘not-for-profit entity’) may submit to the Agency or to a competent authority of the Member State substantive non- clinical or clinical evidence for a new therapeutic indication that is expected to fulfil an unmet medical need.
Amendment 967 #
Proposal for a regulation
Article 48 – paragraph 1 – subparagraph 2
Article 48 – paragraph 1 – subparagraph 2
The Agency may, at the request of a Member State, the Commission, or on its own initiative and on the basis of all available evidence make a scientific evaluation of the benefit-risk of the use of a medicinal product with a new therapeutic indication that concerns an unmet medical need.
Amendment 973 #
Proposal for a regulation
Article 48 – paragraph 2
Article 48 – paragraph 2
2. In cases where the opinion is favourable, marketing authorisation holders of the medicinal products concerned shall submit a variation to update the product information with the new therapeuticbe notified and given the possibility to comment. After consultation with the marketing authorisation holder, the Agency may submit a variation to update the product information with the new therapeutic indication. The marketing authorisation holder shall inform relevant stakeholders, such as healthcare professionals, of the added indication.
Amendment 995 #
Proposal for a regulation
Article 58 – paragraph 4 a (new)
Article 58 – paragraph 4 a (new)
4 a. The Agency shall, to the greatest extent possible, ensure that there is continuation between those responsible for providing scientific advice to a given medicinal product developer and those subsequently responsible for the evaluation of the marketing authorisation application for the same medicinal product.When appointing rapporteurs for the purpose of evaluating marketing authorisation applications, the Agency’s Committee on Medicinal Products for Human Use shall duly take into account any involvement of individuals as coordinators in providing scientific advice for the same medicinal product in the pre- submission stage of activities. It should be noted in the summary minutes of the meetings in accordance with Article 147 (2) whether there was continuation between those responsible for providing scientific advice to a given medicinal product and those subsequently responsible for the evaluation of the marketing authorisation application.
Amendment 1011 #
Proposal for a regulation
Article 60 – paragraph 1 – introductory part
Article 60 – paragraph 1 – introductory part
1. The Agency may offer enhanced scientific and regulatory support, including as applicable consultation with other bodies as referred to in Articles 58 and 59 and accelerated assessment mechanisms, for certain medicinal products that, based on preliminary evidence submitted by the developer fulfil at least one of the following conditions:
Amendment 1016 #
Proposal for a regulation
Article 60 – paragraph 1 – point a
Article 60 – paragraph 1 – point a
(a) are likely to address an unmetadvanced therapy medicinal need as referred to in Article 83(1) of [revised Directive 2001/83/EC];products
Amendment 1369 #
Proposal for a regulation
Article 101 – paragraph 1 – subparagraph 3
Article 101 – paragraph 1 – subparagraph 3
The Eudravigilance database shall contain information on suspected adverse reactions in human beings arising from use of the medicinal product within the terms of the marketing authorisation as well as from uses outside the terms of the marketing authorisation, including medication errors, and on those occurring in the course of post-authorisation studies with the medicinal product or associated with occupational exposure.
Amendment 1387 #
Proposal for a regulation
Article 111 – paragraph 1
Article 111 – paragraph 1
The Agency and the Member States shall cooperate to continuously develop pharmacovigilance systems, including those that record adverse events including medication errors, processes and standards for medication safety, and implement digital technologies in healthcare settings, capable of achieving high standards of public health protection for all medicinal products, regardless of the routes of marketing authorisation, including the use of collaborative approaches, to maximise use of resources available within the Union.
Amendment 1464 #
Proposal for a regulation
Article 116 – paragraph 1 – point a
Article 116 – paragraph 1 – point a
(a) its decision to permanently cease the marketing of a medicinal product in that Member State no less than twelvefour months before the last supply of that medicinal product into the market of a given Member State by the marketing authorisation holder;
Amendment 1467 #
Proposal for a regulation
Article 116 – paragraph 1 – point b
Article 116 – paragraph 1 – point b
(b) its request to permanently withdraw the marketing authorisation for that medicinal product authorised in that Member State no less than twelvefour months before the last supply of that medicinal product into the market of a given Member State by the marketing authorisation holder;
Amendment 1471 #
Proposal for a regulation
Article 116 – paragraph 1 – point c
Article 116 – paragraph 1 – point c
(c) its decision to temporarily suspend the marketing of a medicinal product in that Member State no less than sixtwo months before the start of the temporary suspension of supply of that medicinal product into the market of a given Member State by the marketing authorisation holder;
Amendment 1477 #
Proposal for a regulation
Article 116 – paragraph 1 – point d
Article 116 – paragraph 1 – point d
(d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than sixtwo months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1).
Amendment 1501 #
1. The marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for any medicinal product placas referred oin the marketarticle 127(1) . To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information set out in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2.
Amendment 1549 #
Proposal for a regulation
Article 121 – paragraph 1 – point c a (new)
Article 121 – paragraph 1 – point c a (new)
(c a) shall in order to avert or mitigate an imminent or existing supply shortage relevant to the supply of a medication product request pharmacies supplying hospitals and hospital pharmacies, to communicate electronically data on available stock of the respective medicinal product
Amendment 1579 #
Proposal for a regulation
Article 122 – paragraph 4 – point e a (new)
Article 122 – paragraph 4 – point e a (new)
(e a) specify the systems and procedures to ensure the European Shortages Monitoring Platform (ESMP) includes accurate information on available critical medicinal stocks in legal entities that are authorised or entitled to supply medicinal products to the public including pharmacies supplying hospitals and hospital pharmacies.
Amendment 1649 #
Proposal for a regulation
Article 129 – paragraph 1
Article 129 – paragraph 1
For the purposes of Article 127(4) and Article 130(2), point (c), and Article 130(4), point (c), where relevant, upon request from the competent authority concerned as defined in Article 116(1), entities including other marketing authorisation holders as defined in Article 116(1), importers and manufacturers of medicinal products or active substances and relevant suppliers of these, wholesale distributors, stakeholder representative associations or other persons or legal entities that are authorised or entitled to supply medicinal products to the public, including hospitals and ambulatory care settings, shall provide any information requested in a timely manner.
Amendment 1690 #
Proposal for a regulation
Article 132 – paragraph 1
Article 132 – paragraph 1
1. Following the adoption of the Union list of critical medicinal products pursuant to Article 131(3), in consultation with the Agency and the working party referred to in Article 121(1), point (c), the MSSG may provide recommendations, in accordance with the methods referred to in Article 130(1), point (d), on appropriate security of supply measures to marketing authorisation holders as defined in Article 116(1), the Member States, the Commission or other entities. SuchAny measures may includeor recommendations on diversification of suppliers and inventory managemenshould be justified and risk-based, targeted and proportionate to the identified, underlying root causes of the supply security risk and patient impact.