73 Amendments of Maria Angela DANZÌ related to 2023/0131(COD)
Amendment 214 #
Proposal for a regulation
Recital 4 a (new)
Recital 4 a (new)
(4a) In the interests of public health and with a view to the proper functioning of the EU regulatory framework, an innovative medicinal product should be understood as a medicinal product that satisfies a substantial health need that was previously unsatisfactorily or inadequately met and offers greater efficacy or other incremental benefits than existing therapeutic alternatives.
Amendment 223 #
Proposal for a regulation
Recital 12 a (new)
Recital 12 a (new)
(12a) To prevent influence on the development or implementation of pharmaceutical policies or legislation or the decision-making processes of the Agency and the other EU institutions, the Executive Director, the Deputy Executive Director, the members of the Management Board and the members of the Committees may not, for two years after leaving office, hold any office or accept posts or engage in any activity whether remunerated or free of charge, on behalf of any person over whom they have exercised regulatory, negotiating or authorising powers.
Amendment 252 #
Proposal for a regulation
Recital 34
Recital 34
(34) The simplification of procedures should not have an impact on standards or the quality of scientific evaluation of the medicinal products to guarantee the quality, safety and efficacy of medicinal products. It should also allow for the reduction of the scientific evaluation period from 210 days to 1850 days.
Amendment 260 #
Proposal for a regulation
Recital 36
Recital 36
(36) The expertise of the Committee for Advanced Therapies (CAT), the Committee for Orphan Medicinal Products (COMP), the Paediatric Committee (PDCO) and Committee for Herbal Medicinal Products (HMPC) is retained through working groups, working parties and a pool of experts who are organised based on different domains and who are giving input to the CHMP and PRAC. The CHMP and PRAC consists of experts from all Member States while working parties consist in majority of experts appointed by the Member States, based on their expertise, and of external experts. What is more, with regard to the scientific assessment and the agreement of the paediatric investigation plans and other issues of paediatric interest not falling under the responsibilities of the PRAC and the CHMP, the expertise and experience of the Paediatric Committee will be retained in a paediatric working group that will provide a contribution to the Agency on paediatric issues. The model of rapporteurs remains unchanged. Representation of patients and health care professionals, with expertise in all areas, including rare and paediatric diseases, is increased at the CHMP and PRAC, in addition to the dedicated working groups representing patients and health care professionals.
Amendment 299 #
Proposal for a regulation
Recital 56 a (new)
Recital 56 a (new)
(56a) To prevent delays in treatment and to provide timely access for patients to medicines undergoing clinical trials, the EU body responsible for centralised procurement of medicinal products shall use the framework agreement, as regulated by Directive 2014/24/EU, for the purchase of experimental drugs, as soon as the first phase of Regulation (EU) No 536/2014 has been completed. It is also recommended that the Member States use that institution.
Amendment 335 #
Proposal for a regulation
Recital 78 a (new)
Recital 78 a (new)
Amendment 337 #
Proposal for a regulation
Recital 78 b (new)
Recital 78 b (new)
(78b) Member States, the Union, third countries, international organisations and agencies have identified the key areas of priority pharmaceutical research, including novel antibiotics and antivirals, improved diagnostics and treatments for emerging infectious diseases, affordable and efficacious medicinal products in the areas of oncology and neurodegenerative diseases and other areas of unmet medical need for which the development of orphan medicinal products is needed. However, while Member States and the Union offer generous corporate R&D subsidies as well as R&D tax incentives to stimulate pharmaceutical research, there is little evidence to suggest, and no obligation to ensure, that the composition of R&D portfolios of pharmaceutical companies is determined by such direct or indirect subsidies. It is therefore increasingly evident that effective public health policy is undermined by shortcomings in transparency and accountability in public expenditure on health.
Amendment 341 #
Proposal for a regulation
Recital 78 c (new)
Recital 78 c (new)
(78b) Those market failures highlight the need for a paradigm shift in both the Member States’ and the Union’s approach to generating pharmaceutical R&D in key areas of priority and in public expenditure directed towards health.The establishment at EU of mission-oriented R&D infrastructure which acts in the public interest is a tool to alleviate those market failures.This public law infrastructure must be able to carry out research and development activities concerning novel antimicrobials, and in other sectors where unmet medical needs are common. What is more, with a view to overcoming market failures of that kind, more preliminary purchasing agreements must be concluded and joint procurement must be carried out, with the aim of providing the EU and its Member States with greater flexibility in line with their needs and of ensuring that medicines are available for all EU residents, irrespective of their Member State of origin.
Amendment 345 #
Proposal for a regulation
Recital 78 d (new)
Recital 78 d (new)
(78d) To prevent overlapping of competences and with a view to better coordination and efficiency of the use of public resources, the Commission must present a proposal, where necessary, to streamline and restore the competences of the European Medicines Agency (EMA), the Health Emergency Preparedness and Response Authority (HERA) and the European Centre for Disease Prevention and Control (ECDC).
Amendment 349 #
Proposal for a regulation
Recital 79
Recital 79
Amendment 357 #
Proposal for a regulation
Recital 80
Recital 80
Amendment 363 #
Proposal for a regulation
Recital 81
Recital 81
Amendment 367 #
Proposal for a regulation
Recital 82
Recital 82
Amendment 371 #
Proposal for a regulation
Recital 83
Recital 83
Amendment 376 #
Proposal for a regulation
Recital 84
Recital 84
Amendment 415 #
Proposal for a regulation
Recital 102
Recital 102
(102) In order to incentivise investment and innovation, research and development of orphan medicinal products addressing for whigch 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 mno other therapies exist or, where they already exist, would be a significant benefit for the target population, a modulation of market exclusivity has been introduced. This modulation is based on the science and principles that guide research, with incentives based on practical obstacles, unique attributes and the development needs of new therapies that address patients' needs; the Regulation provides for four main archetypes of incentives, each addressing unique needs and knowledge gaps in research. Market exclusivity for well- established use orphan medicinal products, requiring less investment, is the shortest. In order to ensure increased predictability for developers, the possibility to review the eligibility criteria for market exclusivity after six years after the marketing authorisation has been abolished.
Amendment 429 #
Proposal for a regulation
Recital 104
Recital 104
(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 twoUndertaking 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).;
Amendment 434 #
Proposal for a regulation
Recital 106
Recital 106
(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 importanterative 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.
Amendment 436 #
Proposal for a regulation
Recital 112
Recital 112
(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 casesThe 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.
Amendment 451 #
Proposal for a regulation
Recital 133
Recital 133
(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.
Amendment 513 #
Proposal for a regulation
Recital 155
Recital 155
(155) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union and notably human dignity, the integrity of the person, the rights of the child, respect for private and family life, the protection of personal data and the freedom of art and science. 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.
Amendment 515 #
Proposal for a regulation
Recital 156
Recital 156
(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.
Amendment 537 #
Proposal for a regulation
Article 2 – paragraph 2 – point 9 a (new)
Article 2 – paragraph 2 – point 9 a (new)
(9a) 'Paediatric population' means the proportion of the population aged between infancy and 18.
Amendment 538 #
Proposal for a regulation
Article 2 – paragraph 2 – point 9 b (new)
Article 2 – paragraph 2 – point 9 b (new)
(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;
Amendment 539 #
Proposal for a regulation
Article 2 – paragraph 2 – point 9 c (new)
Article 2 – paragraph 2 – point 9 c (new)
(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];
Amendment 611 #
Proposal for a regulation
Article 6 – paragraph 6 – subparagraph 1
Article 6 – paragraph 6 – subparagraph 1
The Agency shall ensure that the opinion of the Committee for Medicinal Products for Human Use is given within 1850 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.
Amendment 618 #
Proposal for a regulation
Article 6 – paragraph 7 – subparagraph 2
Article 6 – paragraph 7 – subparagraph 2
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 1520 days.
Amendment 619 #
Proposal for a regulation
Article 6 – paragraph 7 a (new)
Article 6 – paragraph 7 a (new)
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];
Amendment 719 #
Proposal for a regulation
Article 19 – paragraph 3
Article 19 – paragraph 3
3. Conditional marketing authorisations or a new conditional therapeutic indication granted pursuant to this Article shall be subject to specific obligations. Those specific obligations and, where appropriate, the time limit for compliance shall be specified in the conditions to the marketing authorisation. Those specific obligations shall be reviewed annually by the Agency for the first three years after granting the authorisation and every two years thereafter.
Amendment 745 #
Proposal for a regulation
Article 24 – paragraph 1 – subparagraph 2 – point f a (new)
Article 24 – paragraph 1 – subparagraph 2 – point f a (new)
(fa) a decision based on commercial grounds, without prejudice to any commercially-confidential information.
Amendment 753 #
Proposal for a regulation
Article 24 – paragraph 4
Article 24 – paragraph 4
4. Where the marketing authorisation holder intends to permanently withdraw the marketing authorisation for a critical medicinal product, the marketing authorisation holder shall, prior to the notification referred to in paragraph 1, offer, on fair and reasonable terms, to transfer the marketing authorisation to a third party that has declared its intention to place that critical medicinal product on the market, or to use the pharmaceutical non-clinical and clinical documentation contained in the file of the medicinal product for the purposes of submitting an application in accordance with Article 14 of [revised Directive 2001/83/EC]. A marketing authorisation holder to whom a marketing authorisation is transferred shall notify the Agency of the transfer within 30 days, stating the value of the transaction between the two parties. The Agency shall publish that information.
Amendment 821 #
Proposal for a regulation
Chapter III – title
Chapter III – title
III ADDRESSING PHARMACEUTICAL MARKET FAILURES IN THE UNION AND GREATER INCENTIVES FOR THE RESEARCH AND DEVELOPMENT OF ‘PRIORITY ANTIMICROBIALS’
Amendment 824 #
Proposal for a regulation
Article 40
Article 40
Amendment 882 #
Proposal for a regulation
Article 40 a (new)
Article 40 a (new)
Amendment 892 #
Proposal for a regulation
Article 40 b (new)
Article 40 b (new)
Article 40b Additional measures to incentivise the creation of antimicrobials 1. The Commission shall furthermore establish a Union push and pull incentive scheme to promote and accelerate the development of novel antimicrobials, as well as to promote increased access to existing and newly developed antimicrobials. Member States shall be encouraged to participate in the Union- level scheme. 2. The Commission is empowered to adopt delegated acts in accordance with Article 175 to supplement this Regulation by further defining the scheme and its funding and shall, at the least, include the development of the following incentives in such delegated acts: a) research grants under Union funds with conditionalities linked to the affordability and supply of new and existing antimicrobials; b) milestone prizes for novel antimicrobial developers with conditionalities linked to the affordability and supply of new and existing antimicrobials;
Amendment 899 #
Proposal for a regulation
Article 41
Article 41
Amendment 926 #
Proposal for a regulation
Article 42
Article 42
Amendment 940 #
Proposal for a regulation
Article 43
Article 43
Amendment 982 #
Proposal for a regulation
Article 56 – paragraph 1
Article 56 – paragraph 1
Where the Agency concludes that a holder of a marketing authorisation granted in accordance with Article 19, including a new therapeutic indication granted referred to Article 19, failed to comply with the obligations laid down in the marketing authorisation, including under Article 20, the Agency shall inform the Commission accordingly.
Amendment 1015 #
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 one of the following conditions:
Amendment 1102 #
Proposal for a regulation
Article 68 – paragraph 1 – introductory part
Article 68 – paragraph 1 – introductory part
1. The orphan medicine sponsor maywill, prior to the submission of an application for marketing authorisation, request advice from the Agency on the following:
Amendment 1107 #
Proposal for a regulation
Article 68 – paragraph 2
Article 68 – paragraph 2
2. Medicinal products designated as orphan medicinal products under the provisions of this Regulation shall be eligible for incentives made available by the Union and by the Member States to support research into, and the development and availability of, orphan medicinal products and in particular aid for research for small- and medium-sized undertakings and not-for-profit entities provided for in framework programmes for research and technological development.
Amendment 1119 #
Proposal for a regulation
Article 70
Article 70
Amendment 1156 #
(a) nintwelve years for orphan medicinal products other than those referred to in points (b) and (c)for whose indication the Union has not approved a satisfactory treatment method;
Amendment 1178 #
Proposal for a regulation
Article 71 – paragraph 2 – point b
Article 71 – paragraph 2 – point b
(b) ten years for orphan medicinal products addressing a high unmetif: 1. the Union has authorised fewer than three (3) orphan medicinal products for the indication in question, or; 2. notwithstanding any authorisations for medicinal products for the condition in question, no orphan medicinal need as referred to in Article 70product has received EU authorisation for part of the target population or subsets thereof as regards the therapeutic indication of the new medicinal product, or; 3. the Union has authorised an orphan medicinal product for use according to its indication, but that orphan medicinal product either has a new mechanism of application or is a new technology;
Amendment 1208 #
Proposal for a regulation
Article 71 – paragraph 2 – point c a (new)
Article 71 – paragraph 2 – point c a (new)
(ca) eight years for orphan medicinal products that are not referred to in points (a), (b) or (c);
Amendment 1244 #
Proposal for a regulation
Article 72 – paragraph 2 – subparagraph 1
Article 72 – paragraph 2 – subparagraph 1
The period of market exclusivity shall be prolonged by an additional 1236 months for orphan medicinal products referred to in Article 71(2), points (a),(b) and (bc a), if at least two years before the end of the exclusivity period, the orphan marketing authorisation holder obtains a marketing authorisation for one or morea new therapeutic indications for a different orphan condition.
Amendment 1252 #
Proposal for a regulation
Article 72 – paragraph 2 – subparagraph 2
Article 72 – paragraph 2 – subparagraph 2
Amendment 1260 #
Proposal for a regulation
Article 72 – paragraph 2 – subparagraph 2 a (new)
Article 72 – paragraph 2 – subparagraph 2 a (new)
When the orphan marketing authorisation holder obtains any further marketing authorisations for one or more therapeutic indications relative to different orphan conditions for the same orphan medicinal product, these specific therapeutic indications shall be protected by a separate market exclusivity of three years from the expiry of the market exclusivity for the entire product pursuant to Article 71, where appropriate in accordance with Article 71(1) and (2).
Amendment 1304 #
Proposal for a regulation
Article 77 – paragraph 1
Article 77 – paragraph 1
1. After the validation of the proposed paediatric investigation plan referred to in Article 74(1)., which is valid in accordance with the provisions of Article 76(2), the Agency shall, after receiving the opinion of its paediatric working party, adopt within 90 days a decision as to whether or not the proposed studies will ensure the generation of the necessary data determining the conditions in which the medicinal product may be used to treat the paediatric population or subsets thereof, and as to whether or not the expected therapeutic benefits, where appropriate also over existing treatments, justify the studies proposed. When adopting its decision, the Agency shall consider whether or not the measures proposed to adapt the pharmaceutical form, the strength, the route of administration and the eventual administration device of the medicinal product for use in different subsets of the paediatric population are appropriate.
Amendment 1310 #
Proposal for a regulation
Article 77 – paragraph 3 – subparagraph 1
Article 77 – paragraph 3 – subparagraph 1
After receiving an updated version of the paediatric investigation plan referred to in Article 74(2), third subparagraph, the Agency shall, after receiving the input of the paediatric working party, review it within 30 days.
Amendment 1314 #
Proposal for a regulation
Article 78 – paragraph 2 – subparagraph 1
Article 78 – paragraph 2 – subparagraph 1
Following the receipt of a valid application in accordance with the provisions of Article 76(2), the Agency shall, after receiving the input of its paediatric working party, within 90 days adopt a decision as to whether or not a product- specific waiver shall be granted.
Amendment 1315 #
3. When appropriate, the Agency may, either of its own motion or acting upon the recommendations of the paediatric working party, adopt decisions, on the basis of the grounds set out in Article 75(1), to the effect that a class or a product-specific waiver, as referred to in Article 75(2), should be granted.
Amendment 1316 #
Proposal for a regulation
Article 78 – paragraph 7
Article 78 – paragraph 7
7. In consultation with the Commission and with interested parties, the Agency and its paediatric working party shall draw up and publish guidelines for the practical application of this Article.
Amendment 1320 #
Proposal for a regulation
Article 81 – paragraph 3
Article 81 – paragraph 3
3. The length of the deferral shall be specified in a decision of the Agency and shall not exceed five years and should ensure that the PIP is completed no more than two years after the marketing authorisation for other populations is granted.
Amendment 1334 #
Proposal for a regulation
Article 84 – paragraph 2 – subparagraph 3
Article 84 – paragraph 2 – subparagraph 3
Within 30 days, and after receiving the opinion of its paediatric working party, the Agency shall review these changes and adopt a decision on their refusal or acceptance.
Amendment 1338 #
Proposal for a regulation
Article 86 – paragraph 1 a (new)
Article 86 – paragraph 1 a (new)
The paediatric experts who are taking part in the CHMP's working parties shall contribute to the conformity assessment.
Amendment 1339 #
Proposal for a regulation
Article 87 – paragraph 1
Article 87 – paragraph 1
1. Decisions referred to in Articles 77, 78, 80, 81, 82 and 84 adopted by the Agency shall be supported by scientific conclusions, which should incorporate the opinion expressed by the paediatric working party and which shall be annexed to the decision.
Amendment 1340 #
Proposal for a regulation
Article 87 – paragraph 2
Article 87 – paragraph 2
2. Where the Agency considers it necessary, it may consult the Committee for Medicinal Products for Human Use or and other appropriate working parties when preparing the above mentioned scientific conclusions. The outcome of such consultations shall be annexed to the decision.
Amendment 1358 #
Proposal for a regulation
Article 91 – paragraph 3
Article 91 – paragraph 3
3. When products are authorised in accordance with the provisions of this Regulation, the Commission may update the summary of product characteristics and package leaflet, including the accurate dosage, and may vary the marketing authorisation accordingly.
Amendment 1365 #
Proposal for a regulation
Article 96 – paragraph 1
Article 96 – paragraph 1
Paediatric medicinal products shall be eligible for incentives made available by the Union and by the Member States to support research into, and the development and availability of, paediatric medicinal products. These incentives will be granted by means of specific calls for research proposals encompassing the product's entire development phase, from discovery to post-marketing, as outlined in the annual paediatric research plans, which are part of the EU's research programmes concerning health and health products.
Amendment 1380 #
Proposal for a regulation
Article 104 – paragraph 1 – subparagraph 1 – point j
Article 104 – paragraph 1 – subparagraph 1 – point j
(j) conclusions of assessments, recommendations, opinions, approvals, obligations deriving from the conditional marketing authorisation and decisions taken by the coordination group, the competent authorities of the Member States and the Commission in the framework of the procedures set out in Articles 16, 106, 107 and 108 of this Regulation and of Chapter IX, Sections 3 and 7 of [revised Directive 2001/83/EC].
Amendment 1398 #
Proposal for a regulation
Article 113 – paragraph 1 – point a
Article 113 – paragraph 1 – point a
(a) it is not possible to develop the medicinal product, even if medical devices or in-vitro diagnostic are used as combined products, 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;
Amendment 1483 #
Proposal for a regulation
Article 116 – paragraph 1 – point d
Article 116 – paragraph 1 – point d
(d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder and of the public authorities no less than six months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1).
Amendment 1520 #
Proposal for a regulation
Article 118 – paragraph 2
Article 118 – paragraph 2
2. For the purposes of paragraph 1, the competent authority concerned as defined in Article 116(1) may request any additional information from the marketing authorisation holder as defined in Article 116(1). In particular, it may request the marketing authorisation holder to submit a shortage mitigation plan in accordance with Article 119(2), a risk assessment of impact of suspension, cessation or withdrawal in accordance with Article 119(3), or the shortage prevention plan referred to in Article 117. The competent authority concerned mayshall set a deadline for the submission of the information requested.
Amendment 1539 #
Proposal for a regulation
Article 121 – paragraph 1 – point b
Article 121 – paragraph 1 – point b
(b) publish on a publicly available website information on actual shortages of medicinal products, in cases in which that competent authority has assessed the shortage, on a publicly available websitcluding the known reasons for them, where appropriate in accordance with points (a) to (fa) of the second subparagraph of Article 24(1), in cases in which that competent authority has assessed the shortage and provided recommendations to health-care professionals and patients, including on the alternatives available;
Amendment 1600 #
Proposal for a regulation
Article 123 – paragraph 4
Article 123 – paragraph 4
4. The MSSG mayshall provide recommendations on measures to resolve or to mitigate the critical shortage, as well as on alternatives available, in accordance with the methods referred to in Article 122(4), point (d), to relevant marketing authorisation holders, the Member States, the Commission, the representatives of healthcare professionals or other entities.
Amendment 1623 #
Proposal for a regulation
Article 125 – paragraph 1 – point c
Article 125 – paragraph 1 – point c
(c) take into accountcomply with the recommendations referred to in Article 123(4);
Amendment 1626 #
Proposal for a regulation
Article 125 – paragraph 1 – point f
Article 125 – paragraph 1 – point f
(f) inform the Agency of the causes and the end date of the critical shortage.
Amendment 1643 #
Proposal for a regulation
Article 128 – paragraph 2 a (new)
Article 128 – paragraph 2 a (new)
2a. The marketing authorisation referred to in Article 116(1) shall also entail the obligation to establish and maintain minimum safety stocks of critical medicinal products set out in Article 131.The minimum safety stocks of critical medicinal products shall be sufficient to cover demand for them for a period of two months in the Member States in which the medicinal product is marketed. The marketing authorisation holder may apply to the relevant authority for an exemption from maintaining minimum safety stocks on the following grounds: (a) the manufacturing process or shelf life of the critical medicinal product is incompatible with the duration of the minimum safety stock; (b) other valid reasons agreed with the relevant authority.
Amendment 1662 #
Proposal for a regulation
Article 130 – paragraph 1 – subparagraph 1 – point a
Article 130 – paragraph 1 – subparagraph 1 – point a
(a) develop a common methodology to identify critical medicinal products, including the evaluation of vulnerabilities with respect to the supply chain of those medicines, in consultation, where appropriate, with relevant stakeholders;
Amendment 1666 #
Proposal for a regulation
Article 130 – paragraph 1 – subparagraph 2
Article 130 – paragraph 1 – subparagraph 2
The Agency shall publish the information referred to in points (b), (c) andda(a) to (d) on a dedicated webpage on its web-portal.
Amendment 1695 #
Proposal for a regulation
Article 133 – paragraph 1 – point c
Article 133 – paragraph 1 – point c
(c) take into accountcomply with the recommendations referred to in Article 132(1);