58 Amendments of Stelios KYMPOUROPOULOS related to 2023/0131(COD)
Amendment 232 #
Proposal for a regulation
Recital 20
Recital 20
(20) Promising medicinal products and medical devices that have the potential to significantly address patients’ unmet medical needs should benefit from early and enhanced scientific support. Such support will ultimately help patients benefit from new therapies as early as possible.
Amendment 245 #
Proposal for a regulation
Recital 30
Recital 30
(30) The Agency should be empowered to give scientific recommendations on whether a product under development, which could potentially fall under the mandatory scope of the centralised procedure, meets the scientific criteria to be a medicinal product. Such an advisory mechanism would address, as early as possible, questions related to borderline cases with other areas such as in particular substances of human origin, cosmetics or medical devices, which may arise as science develops. To ensure that recommendations given by the Agency take into account the views of equivalent advisory mechanisms in other legal frameworks, the Agency should consult the relevant advisory or regulatory bodies. In the case of the advanced therapy medicinal products (ATMPs), the EMA working group on ATMPs shall consult the SoHO Coordination Board.
Amendment 264 #
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. The model of rapporteurs remains unchanged. Representation of patients, their caregivers 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 271 #
Proposal for a regulation
Recital 39
Recital 39
(39) To allow for a more informative decision making and for exchange of information and pooling of knowledge on general issues of scientific or technical nature related to the tasks of the Agency regarding medicinal products for human use, in particular to scientific guidelines on unmet medical needs and the design of clinical trials, or other studies and the generation of evidence along the life cycle of medicinal product, the Agency should be able to have recourse to a consultation process of authorities or bodies active along the life cycle of medicinal products. These authorities could be, as appropriate, representatives from Heads of Medicines Agencies, the Clinical Trial Coordination and Advisory Group, the SoHO Coordination Board, the Coordination Group on Health Technology Assessment, Medical Devices Coordination Group, medical devices national competent authorities, national competent authorities for pricing and reimbursement of medicines, national insurance funds or healthcare payers. The Agency should also be able to extend the consultation mechanism to consumers, patients, their caregivers, healthcare professionals, acdemia, industry, associations representing payers, or other stakeholders, as relevant.
Amendment 296 #
Proposal for a regulation
Recital 53 a (new)
Recital 53 a (new)
(53 a) Several care pathways should be explored to make therapies available in all Member States, including by advancing provisions for access to cross border care such as Directive 2011/24/EU and Regulation (EC) No 883/2004. This is particularly important for the advanced therapy medicinal products (ATMPs), as their unique characteristics result in significant infrastructural complexities and system barriers, which can substantially limit their continuously supply.
Amendment 305 #
Proposal for a regulation
Recital 60
Recital 60
(60) Regulatory decision-making on the development, authorisation and supervision of medicinal products may be supported by access and analysis of health data, including real world data, where appropriate, i.e. health data generated outside of clinical studies, and/or data generated via in silico methods, such as computational modelling and simulation, digital molecular representation and mechanistic modelling, digital twin and artificial intelligence (AI). The Agency should be able to use such data, including via the Data Analysis and Real World Interrogation Network (DARWIN) and the European Health Data Space interoperable infrastructure. Through these capabilities the Agency may take advantage of all the potential of supercomputing, artificial intelligence and big data science, including results of studies conducted via insilico methods, to fulfil its mandate, without compromising privacy rights. Where necessary the Agency may cooperate with the competent authorities of the Member States towards this objective.
Amendment 380 #
(84 a) The Transferable Exclusivity Vouchers (TEV) could be complemented by a procurement mechanism, as outlined in the Council Recommendation on “Stepping up actions to combat AMR in a One Health approach”, providing coordinated financial commitment across the EU and Member States. This would provide the predictability that will encourage comprehensive commercialisation of new priority antimicrobials.
Amendment 407 #
Proposal for a regulation
Recital 93
Recital 93
(93) If a satisfactory method of diagnosis, prevention or treatment of the condition in question has already been authorised in the Union, the orphan medicinal product will have to be of significant benefit to those affected by that condition. In this context, a medicinal product authorised in one Member State is generally deemed as being authorised in the Union. It is not necessary for it to have Union authorisation or to be authorised in all Member States to be considered as a satisfactory method. In addition, commonly used methods of diagnosis, prevention or treatment that are not subject to a marketing authorisation may be considered satisfactory if there is scientific evidence of their efficacy and safety. In certain cases, medicinal products prepared for an individual patient in a pharmacy according to a medical prescription, or according to the prescriptions of a pharmacopoeia and intended to be supplied directly to patients served by the pharmacy, may be considered as satisfactory treatment if they are well known and safe and this is a general practice for the relevant patient population in the Union. This shall not apply to advanced therapy medicinal products.
Amendment 442 #
Proposal for a regulation
Recital 132 a (new)
Recital 132 a (new)
(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.
Amendment 449 #
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 importsignificant in the face of high uncertainty and disruptive challenges, as well as when preparing new policies. Regulatory sandboxesIt 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 provideing 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 especialparticularly 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.
Amendment 454 #
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 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.
Amendment 509 #
Proposal for a regulation
Recital 145
Recital 145
(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.
Amendment 526 #
Proposal for a regulation
Article 2 – paragraph 2 – point 7
Article 2 – paragraph 2 – point 7
(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;
Amendment 542 #
Proposal for a regulation
Article 2 – paragraph 2 – point 10
Article 2 – paragraph 2 – point 10
(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 are likely to fall in the scope of this Regulationcan be regulated as medicinal products or other categories of products, pursuant to a specific plan and for a limited time under regulatory supervision.
Amendment 601 #
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 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.
Amendment 605 #
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 does no longer present great interest for public health. The Agency shall inform the applicant accordingly.
Amendment 638 #
Proposal for a regulation
Article 10 – paragraph 2
Article 10 – paragraph 2
2. Where within 960 days of the validation of the marketing authorisation application and during the assessment the Committee for Medicinal Products for Human Use considers that the submitted data are not of sufficient quality or maturity to complete the assessment, the assessment can be terminated. The Committee for Medicinal Products for Human Use shall summarise the deficiencies in writing. On this basis, the Agency shall inform the applicant accordingly and set a time limit to address the deficiencies. The application shall be suspended until the applicant addresses the deficiencies. If the applicant fails to address those deficiencies within the time limit set by the Agency, the application shall be considered as withdrawn.
Amendment 764 #
Proposal for a regulation
Article 26 – paragraph 4 – subparagraph 1
Article 26 – paragraph 4 – subparagraph 1
When compassionate use is envisaged by a Member State, or by the applicant or sponsor, the Committee for Medicinal Products for Human Use, after consulting the manufacturer or the applicant, may adopt opinions on the conditions for use, the conditions for distribution and the patients targeted. The opinions shall be updated where necessary.
Amendment 771 #
Proposal for a regulation
Article 26 – paragraph 6
Article 26 – paragraph 6
6. The Agency shall keep an up-to- date list of the opinions adopted in accordance with paragraph 4 and shall publish it on its website in an accessible, searchable data format.
Amendment 914 #
Proposal for a regulation
Article 41 – paragraph 1 – subparagraph 2
Article 41 – paragraph 1 – subparagraph 2
A voucher shall only be used once and in relation to a single centrally authorised medicinal product and only if that product is within its first fourhas at least two years of regulatory data protection remaining.
Amendment 934 #
Proposal for a regulation
Article 42 – paragraph 2
Article 42 – paragraph 2
2. The Commission may revoke the voucher prior to its transfer as referred to in Article 41(3) if ain normal circumstances, a reasonable request for supply, procurement or purchase of the priority antimicrobial in the Union has not been fulfilled, where such request is consistent with the expected needs of the Union market and the non-fulfilment is not due to circumstances beyond the control of the marketing authorisation holder .
Amendment 950 #
Proposal for a regulation
Article 43 – paragraph 1
Article 43 – paragraph 1
This Chapter shall apply until [Note to OP: insert the date offrom the entry into force of this Regulation. 15 years after the date of entry into force of this Regulation] or until the date when the Commission has granted a total of 10 vouchers in accordance with this Chapter, whichever date is the earliest, the Commission shall submit a report to the European Parliament and to the Council containing a scientific assessment measuring progress towards sustainable antimicrobial research and development and according to future medical needs.
Amendment 1008 #
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 or medical devices that, based on preliminary evidence submitted by the developer fulfil the following conditions:
Amendment 1027 #
Proposal for a regulation
Article 60 – paragraph 1 – point b
Article 60 – paragraph 1 – point b
(b) are orphan medicinal products or certain medical devices and are likely to address a high unmet medical need as referred to in Article 70(1);
Amendment 1031 #
Proposal for a regulation
Article 60 – paragraph 1 – point c
Article 60 – paragraph 1 – point c
(c) provide an exceptional therapeutic advancement or are expected to be of major interest from the point of view of public health, in particular as regards therapeutic innovation, taking into account the early stage of development, or antimicrobials with any of the characteristics mentioned in Article 40(3).
Amendment 1035 #
Proposal for a regulation
Article 60 – paragraph 2
Article 60 – paragraph 2
2. The Agency, at the request of the Commission and after consulting the EMA Emergency Task Force, may offer enhanced scientific and regulatory support to developers of a certain medicinal product or medical device preventing, diagnosing or treating a disease resulting from serious cross border threats to health if access to such products is considered necessary to ensure high level of Union preparedness and response to health threats.
Amendment 1036 #
Proposal for a regulation
Article 60 – paragraph 3
Article 60 – paragraph 3
3. The Agency may stop the enhanced support if it is established that the medicinal product or the medical device will not address the identified unmet medical need to the anticipated extent.
Amendment 1079 #
Proposal for a regulation
Article 66 – paragraph 1
Article 66 – paragraph 1
Amendment 1084 #
Proposal for a regulation
Article 66 – paragraph 2
Article 66 – paragraph 2
Amendment 1088 #
Proposal for a regulation
Article 66 – paragraph 3
Article 66 – paragraph 3
Amendment 1100 #
Proposal for a regulation
Article 68 – paragraph 1 – introductory part
Article 68 – paragraph 1 – introductory part
1. The orphan medicine sponsor mayshall, prior to the submission of an application for marketing authorisation, request advice from the Agency on the following:
Amendment 1110 #
Proposal for a regulation
Article 68 – paragraph 2 – subparagraph 1 (new)
Article 68 – paragraph 2 – subparagraph 1 (new)
For the purpose of paragraph 2, the definitions set out in Article 58a paragraph 1 of [revised Directive 2001/83/EC] shall apply.
Amendment 1149 #
Proposal for a regulation
Article 70 – paragraph 3
Article 70 – paragraph 3
3. Where the Agency adopts scientific guidelines for the application of this Article, it shall consult the Commission and the authorities or bodies, as well as the stakeholders such as representatives of patients' organisations in the relevant disease areas, healthcare professionals, orphan medicinal product sponsors, representatives of pharmaceutical industry and other relevant stakeholders referred to in Article 162.
Amendment 1151 #
Proposal for a regulation
Article 70 – paragraph 3
Article 70 – paragraph 3
3. Where the Agency adopts scientific guidelines for the application of this Article, it shall consult the Commission, all relevant stakeholders and the authorities or bodies referred to in Article 162.
Amendment 1167 #
Proposal for a regulation
Article 71 – paragraph 2 – point a
Article 71 – paragraph 2 – point a
(a) nineten years for orphan medicinal products other than those referred to in points (b) and (c);
Amendment 1183 #
Proposal for a regulation
Article 71 – paragraph 2 – point b
Article 71 – paragraph 2 – point b
(b) twelven years for orphan medicinal products addressing a high unmet medical need as referred to in Article 70;
Amendment 1195 #
Proposal for a regulation
Article 71 – paragraph 2 – point b a (new)
Article 71 – paragraph 2 – point b a (new)
(b a) twelve years for orphan medicinal products addressing an unmet medical need as referred to in Article 70 in the paediatric population;
Amendment 1367 #
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 errors of medication, and on those occurring in the course of post-authorisation studies with the medicinal product or associated with occupational exposure.
Amendment 1391 #
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, and implement digital technologies in healthcare proceedings, 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 1407 #
Proposal for a regulation
Article 113 – paragraph 2 – subparagraph 1
Article 113 – paragraph 2 – subparagraph 1
The regulatory sandbox shall set out a regulatory framework, including scientific requirements, for the development and, where appropriate clinical trials and placing on the market of a product referred to in paragraph 1 under the conditions set out in this Chapter. The regulatory sandbox may allow targeted derogations to this Regulation, [revised Directive 2001/83/EC] or Regulation (EC) 1394/2007 under the conditions set out in Article 114, while balancing innovation in regulatory procedures with patient safety.
Amendment 1417 #
Proposal for a regulation
Article 113 – paragraph 3
Article 113 – paragraph 3
3. Taking into account HTA expertise, the Agency shall monitor the field of emerging medicinal products and may request information and data from marketing authorisation holders, developers, independent experts and researchers, and representatives of healthcare professionals and of patients and may engage with them in preliminary discussions.
Amendment 1419 #
Proposal for a regulation
Article 113 – paragraph 3 a (new)
Article 113 – paragraph 3 a (new)
3 a. The regulatory sandbox may also cover the exploration and application of medical devices, in-vitro diagnostics, in silico methods, AI and machine learning technologies in the developement, manifacturing, quality control, and administration of medicinal products, as their use can significanlty add to the efficiency, safety, and effectiveness of the life cycle of medicinal products.
Amendment 1424 #
Proposal for a regulation
Article 113 – paragraph 4 – subparagraph 1
Article 113 – paragraph 4 – subparagraph 1
Where the Agency considers it appropriate to set up a regulatory sandbox for medicinal products (inlcuding ATMPs), or medical devices and other technologies, which are likely to fall under the scope of this Regulation, it shall provide a recommendation to the Commission. The Agency shall list eligible products or category of products in that recommendation and shall include the sandbox plan referred to in paragraph 1.
Amendment 1426 #
Proposal for a regulation
Article 113 – paragraph 4 – subparagraph 1
Article 113 – paragraph 4 – subparagraph 1
Where the Agency considers it appropriate to set up a regulatory sandbox for medicinal products which are likely to fall under the scope of this Regulation or other relevant Union legislation, it shall provide a recommendation to the Commission. The Agency shall list eligible products or category of products in that recommendation and shall include the sandbox plan referred to in paragraph 1.
Amendment 1428 #
Proposal for a regulation
Article 113 – paragraph 5
Article 113 – paragraph 5
5. The Agency shall be responsible for developing a sandbox plan based on data submitted by developers of eligible products and following appropriate consultations including, where relevant, with academia, HTA bodies, patients and their caregivers, healthcare professionals, sponsors, or developers. The plan shall set out clinical, scientific and regulatory justification for a sandbox, including the identification of the requirements of this Regulation, [revised Directive 2001/83/EC] and, Regulation (EC) 1394/2007 and other relevant Union legislation that cannot be complied with and a proposal for alternative or mitigation measures, where appropriate. The plan shall also include a proposed timeline for the duration of the sandbox. Where appropriate, the Agency shall also propose measures in order to mitigate any possible distortion of market conditions as a consequence of establishing a regulatory.
Amendment 1429 #
Proposal for a regulation
Article 113 – paragraph 5
Article 113 – paragraph 5
5. The Agency shall be responsible for developing a sandbox plan based on data submitted by developers of eligible products and following appropriate consultations, by where relevant, HTA bodies, healthcare professionals, patients and their caregivers, and other relevant stakeholders. The plan shall set out clinical, scientific and regulatory justification for a sandbox, including the identification of the requirements of this Regulation, [revised Directive 2001/83/EC] and Regulation (EC) 1394/2007 that cannot be complied with and a proposal for alternative or mitigation measures, where appropriate. The plan shall also include a proposed timeline for the duration of the sandbox. Where appropriate, the Agency shall also propose measures in order to mitigate any possible distortion of market conditions as a consequence of establishing a regulatory.
Amendment 1440 #
Proposal for a regulation
Article 113 – paragraph 7 – point c
Article 113 – paragraph 7 – point c
(c) include as part of the sandbox plan the requirements of this Regulation and, of [revised Directive 2001/83/EC] or of other relevant Union legislation that cannot be complied with and shall include appropriate measures to mitigate potential risks to health and to the environment.
Amendment 1482 #
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 sixthree 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 1502 #
Proposal for a regulation
Article 117 – paragraph 1
Article 117 – paragraph 1
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 critical medicinal product placed on the market. 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 1508 #
Proposal for a regulation
Article 117 – paragraph 2
Article 117 – paragraph 2
2. The Agency, in collaboration with the working party referred to in Article 121(1), point (c), and other relevant parties, shall draw up guidance to marketing authorisation holders as defined in Article 116(1) to put in place the shortage prevention plan.
Amendment 1531 #
Proposal for a regulation
Article 120 – paragraph 2
Article 120 – paragraph 2
2. For the purposes of Article 118(1), where relevant, upon request from the competent authority concerned as defined in Article 116(1), entities including other marketing authorisation holders as defined in Article 116(1), importers and manufacturers of medicinal products or active substances and relevant suppliers of these, wholesale distributors, stakeholder representative associations or other persons or legal entities that are authorised or entitled to supply medicinal products to the public shall provide any information requested in a timely manner. Commercially sensitive information shall only be accessible by the relevant competent authorities.
Amendment 1538 #
Proposal for a regulation
Article 121 – paragraph 1 – point b
Article 121 – paragraph 1 – point b
(b) publish information on actual shortages of medicinal products, in cases in which that competent authority has assessed the shortage, on a publicly available website;as well as measures taken to counter the shortages, as soon as that competent authority has assessed the shortage and provided concrete recommendations, on a publicly available and user-friendly website. The Member State shall, with no undue delay, inform the Agency of any anticipated measures or measures taken at national level to mitigate the shortage.
Amendment 1545 #
Proposal for a regulation
Article 121 – paragraph 1 – point b a (new)
Article 121 – paragraph 1 – point b a (new)
(b a) establish an accessible and easily understandable system for patient organisations to report shortages of medicinal products;
Amendment 1557 #
Proposal for a regulation
Article 121 – paragraph 1 a (new)
Article 121 – paragraph 1 a (new)
1 a. shall request pharmacies supplying hospitals or hospital pharmacies, to communicate electronic data on the availability and stock of the relevant medicinal product, in order to mitigate or avert supply shortage.
Amendment 1561 #
Proposal for a regulation
Article 121 – paragraph 5 – point d
Article 121 – paragraph 5 – point d
(d) as soon as possible inform the Agency of any actions foreseen or taken by that Member State in accordance with points (b) and (c) and report on any other actions taken to mitigate or resolve the critical shortage in the Member State, as well as the results of these actions.
Amendment 1581 #
Proposal for a regulation
Article 122 – paragraph 4 – point e a (new)
Article 122 – paragraph 4 – point e a (new)
(e a) suggest specific procedures to include accurate information, at the European Shortages Monitoring Platform (ESMP), on available critical medicinal stocks in legal entities authorised or entitled to supply medicinal products to the public.
Amendment 1590 #
6. For the purposes of implementing this Regulation, the Agency shall expand the scope of the ESMP. The Agency shall ensure that, where relevant, data is interoperable between the ESMP, Member States’ IT systems and other relevant IT systems and databases, without duplication of reporting, and that the ESMP is automated and digitalised.
Amendment 1605 #
Proposal for a regulation
Article 123 – paragraph 4
Article 123 – paragraph 4
4. The MSSG may provide as soon as possible recommendations on measures to resolve or to mitigate the critical shortage, 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.