Activities of Kateřina KONEČNÁ related to 2023/0131(COD)
Shadow reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006
Amendments (73)
Amendment 216 #
Proposal for a regulation
Recital 5
Recital 5
(5) The COVID-19 pandemic has spotlighted critical issues which require a reform of the Union pharmaceuticals framework to strengthen its resilience and to ensure that it serves the people under all circumstances. In light of the disparities in terms of national immunization infrastructures and preparation highlighted by the COVID-19 pandemic, Member States should strengthen their national immunization programmes, ensuring a proper protection of their population against infectious diseases and building sustainable pandemic responses.
Amendment 324 #
Proposal for a regulation
Recital 76
Recital 76
(76) It is considered appropriate to also have the possibility for the Commission to grant temporary emergency marketing authorisations to address public health emergencies. Temporary emergency marketing authorisations may be granted provided that, having regard to the circumstances of the public health emergency, the benefit of the immediate availability on the market of the medicinal product concerned outweighs the risk inherent to the fact that additional comprehensive quality, non-clinical, clinical data may still be required. A temporary emergency marketing authorisation should be valid only during the public health emergency. The Commission should be given the possibility to vary, suspend or revoke such marketing authorisations in order to protect public health or when the marketing authorisation holder has not complied with the conditions and obligations set out in the temporary emergency marketing authorisation or when a standard or conditional marketing authorisation has been granted for the relevant indication.
Amendment 384 #
Proposal for a regulation
Recital 87 a (new)
Recital 87 a (new)
(87 a) The European Parliament adopted a resolution of 10 July 2020 on the EU’s public health strategy post-COVID-19, which requested an EU Action plan for rare diseases.
Amendment 546 #
Proposal for a regulation
Article 2 – paragraph 2 – point 11
Article 2 – paragraph 2 – point 11
(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).
Amendment 551 #
Proposal for a regulation
Article 2 – paragraph 2 – point 11 a (new)
Article 2 – paragraph 2 – point 11 a (new)
(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 the best care of patients;
Amendment 563 #
Proposal for a regulation
Article 2 – paragraph 2 – point 12
Article 2 – paragraph 2 – point 12
(12) ‘shortage’ means a situation in which the supply of a medicinal product that is authorised and placed on the market in a Member State does not meet the demand for that medicinal product in that Member State whatever the cause.
Amendment 566 #
Proposal for a regulation
Article 2 – paragraph 2 – point 12 a (new)
Article 2 – paragraph 2 – point 12 a (new)
(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;
Amendment 640 #
Proposal for a regulation
Article 10 – paragraph 2
Article 10 – paragraph 2
2. Where within 90 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 withdrawndeemed to have lapsed.
Amendment 644 #
Proposal for a regulation
Article 12 – paragraph 4 – point i
Article 12 – paragraph 4 – point i
(i) in case of medicinal products for which there is substantial, on duly justified grounds described in the assessment report, there is uncertainty as to the surrogate endpoint relation to the expected health outcome, where appropriate and relevant for the benefit-risk balance, with particular attention to new active substances and therapeutic indications, a post- authorisation obligation to substantiate the clinical benefit;
Amendment 675 #
Proposal for a regulation
Article 16 – paragraph 3 – subparagraph 1
Article 16 – paragraph 3 – subparagraph 1
The Agency shall immediately publish the assessment report on the medicinal product for human use and the reasons for its opinion in favour of granting marketing authorisation, after deletion of any information of a commercially confidential nature unless there is an overriding public interest in disclosure.
Amendment 682 #
Proposal for a regulation
Article 16 – paragraph 3 – subparagraph 2 a (new)
Article 16 – paragraph 3 – subparagraph 2 a (new)
When the medicinal product is an antimicrobial, the Agency shall publish the information referred to in Article 17 of [revised Directive 2001/83/EC], as well as any obligations imposed on the marketing authorisation holder if it finds the risk mitigation measures contained in the stewardship plan unsatisfactory.
Amendment 684 #
Proposal for a regulation
Article 17 – paragraph 1
Article 17 – paragraph 1
1. Without prejudice to paragraph 2, aA marketing authorisation for a medicinal product shall be valid for an unlimited periodfive years; the marketing authorisation may be renewed after five years on the basis of a re-evaluation of the risk-benefit balance by Agency.
Amendment 687 #
Proposal for a regulation
Article 17 – paragraph 1 a (new)
Article 17 – paragraph 1 a (new)
1 a. By way of derogation from the first subparagraph, the marketing authorisation for the medicinal products described in Article 9 of [revised Directive 2001/83/EC] shall be valid for an unlimited period.
Amendment 688 #
Proposal for a regulation
Article 17 – paragraph 2 – subparagraph 1
Article 17 – paragraph 2 – subparagraph 1
Amendment 713 #
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, in particular for the studies mentioned in paragraph 4 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. Real world evidence, preferably from the EU, shall be submitted by marketing authorisation holder on regular and compulsory basis before granting the renewed conditional marketing authorisation.
Amendment 721 #
Proposal for a regulation
Article 19 – paragraph 3 a (new)
Article 19 – paragraph 3 a (new)
3 a. The Commission shall, in accordance with Article 172, impose financial penalties to the marketing authorisation holder for unjustified situations of non-compliance with specific obligations, in particular for delays in the submission of study results.
Amendment 722 #
Proposal for a regulation
Article 19 – paragraph 4
Article 19 – paragraph 4
4. As part of the specific obligations referred to in paragraph 3, the marketing authorisation holder of a conditional marketing authorisation granted pursuant to this Article shall be required to complete ongoing studies, or to conduct new studies, with a view to confirming that the benefit- risk balance is favourable. The Agency shall lay down deadlines and criteria for the fulfilment of these conditions and make them publicly available. The holder of a conditional marketing authorisation shall respond to a Member State’s call for negotiation and conclusion of a risk- sharing or managed entry agreement when such institute is required for making the medicinal product available to patients in the Member State.
Amendment 732 #
Proposal for a regulation
Article 19 – paragraph 8 a (new)
Article 19 – paragraph 8 a (new)
8 a. The Agency shall publish in a database the list of conditional marketing authorisations, together with the following information: (a) specific obligations to be fulfilled by the marketing authorisation holder; (b) timelines for compliance with specific obligations; (c) any delays by the marketing authorisation holder regarding the fulfilment of obligations and the reasons for it; (d) any penalties imposed by the Commission on the marketing authorisation holder for non-compliance with the specific obligations, in accordance with Article 172; (e) any actions on the conditional marketing authorisation taken in accordance with Article 56.
Amendment 746 #
Proposal for a regulation
Article 24 – paragraph 1 – subparagraph 2 – point f a (new)
Article 24 – paragraph 1 – subparagraph 2 – point f a (new)
(f a) commercial reasons.
Amendment 754 #
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 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]. The competent authority of the Member State may extend the obligation referred to in the first subparagraph to a marketing authorisation holder that intends to permanently withdraw the marketing authorisation for a non-critical medicinal product.
Amendment 777 #
Proposal for a regulation
Article 29 – paragraph 1 a (new)
Article 29 – paragraph 1 a (new)
Marketing authorisation holders that benefit from regulatory protection shall disclose information on research and development costs in accordance with Article 84a of the aforementioned Directive.
Amendment 780 #
Proposal for a regulation
Article 30 – paragraph 1
Article 30 – paragraph 1
During a public health emergency, the Commission may, following an application by a developer, grant a temporary emergency marketing authorisation (‘TEMA’) or a new temporary emergency therapeutic indication, including when grouped with an extension of an existing marketing authorisation under this Regulation, for medicinal products intended for the treatment, prevention or medical diagnosis of a serious or life-threatening disease or condition which are directly related to the public health emergency, prior to the submission of the complete quality, non- clinical, clinical data and environmental data and information.
Amendment 787 #
Proposal for a regulation
Article 31 – paragraph 1 – introductory part
Article 31 – paragraph 1 – introductory part
A temporary emergency marketing authorisation or a temporary emergency therapeutic indication, including when grouped with an extension of the marketing authorisation, may be granted only after the recognition of a public health emergency at Union level in accordance with Article 23 of Regulation (EU) 2022/2371 of the European Parliament and of the Council 67 and where the following requirements are met: _________________ 67 Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU (OJ L 314, 6.12.2022, p. 26).
Amendment 788 #
Proposal for a regulation
Article 31 – paragraph 1 – point a
Article 31 – paragraph 1 – point a
(a) there is no other satisfactory method of treatment, prevention or diagnosis authorised or sufficiently available in the Union or, if such method is already available, the temporary emergency marketing authorisation of the medicinal productr new temporary emergency therapeutic indication of the medicinal product, including when grouped with an extension of the marketing authorisation, will contribute to address the public health emergency;
Amendment 792 #
Proposal for a regulation
Article 31 – paragraph 1 – point b
Article 31 – paragraph 1 – point b
(b) based on the scientific evidence available, the Agency issues an opinion concluding that the medicinal product could be effective in treating, preventing or diagnosing the disease or condition directly related to the public health emergency, and the known and potential benefits of the product outweigh the known and potential risks of the product, taking into consideration the threat posed by the public health emergency. The Agency shall ensure that expectations of benefits are plausible.
Amendment 798 #
Proposal for a regulation
Article 32 – paragraph 3
Article 32 – paragraph 3
3. The Agency shall transmit without undue delay to the Commission the scientific opinion and its updates and any recommendations on the temporary emergency marketing authorisation or new temporary emergency therapeutic indication, including when grouped with an extension of the marketing authorisation.
Amendment 807 #
Proposal for a regulation
Article 34 – paragraph 1
Article 34 – paragraph 1
The temporary emergency marketing authorisation or temporary emergency therapeutic indication, including when grouped with an extension of the marketing authorisation, shall cease to be valid when the Commission terminates the recognition of a public health emergency in accordance with Article 23(2) and (4) of Regulation (EU) 2022/2371.
Amendment 810 #
Proposal for a regulation
Article 34 – paragraph 1 a (new)
Article 34 – paragraph 1 a (new)
1a. Without prejudice to Article 37, when the temporary emergency marketing authorisation or temporary emergency therapeutic indication, including when grouped with an extension of the marketing authorisation, ceases to be valid in accordance with paragraph 1 of this Article, a transitional period shall be set by the Agency in order to avoid any disruption in supply of the medicinal product concerned.
Amendment 812 #
Proposal for a regulation
Article 35 – paragraph 1 – point d a (new)
Article 35 – paragraph 1 – point d a (new)
(d a) a marketing authorization is granted in accordance with Article 36, subparagraph 1.
Amendment 816 #
Proposal for a regulation
Article 36 – paragraph 1 a (new)
Article 36 – paragraph 1 a (new)
To ensure a smooth administrative conversion of the temporary marketing authorization referred under Article 33 into a marketing authorisation under Articles 13, 16 or 19 according to paragraph 1, and in order to avoid any disruption in availability on the market of the medicinal products concerned, a transitional period shall be set by the Agency.
Amendment 825 #
Proposal for a regulation
Article 40
Article 40
Amendment 889 #
Proposal for a regulation
Article 40 a (new)
Article 40 a (new)
Article 40a Development and access to antimicrobials The Commission shall examine specific incentives and joint procurement procedures and propose measures to promote research, development, and accessibility of antimicrobials by [OP please insert the date = one year after the date of entering into force of this Regulation].
Amendment 900 #
Proposal for a regulation
Article 41
Article 41
Amendment 931 #
Proposal for a regulation
Article 42
Article 42
Amendment 945 #
Proposal for a regulation
Article 43
Article 43
Amendment 961 #
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 966 #
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 992 #
Proposal for a regulation
Article 58 – paragraph 4
Article 58 – paragraph 4
4. The Agency shall include in the European public assessment report the key areas of thea detailed log of pre-submission activities, including scientific advice, once the corresponding marketing authorisation decision has been taken in relation to the medicinal product, after deletion of any information of a commercially confidential nature. , unless there is an overriding public interest in disclosure. In addition, the Agency shall publish and update on a monthly basis the list of products accepted for scientific advice together with the following information: (a) Name of the active substance; (b) Substance type; (c) Therapeutic area; (d) Therapeutic indication; (e) Type of data supporting the request; (f) Type of applicant; (g) Date of acceptance of the scientific advice request.
Amendment 997 #
Proposal for a regulation
Article 58 – paragraph 4 a (new)
Article 58 – paragraph 4 a (new)
4 a. When granting scientific advice, the Agency shall ensure to the greatest extent possible that there is a separation between those responsible for providing scientific advice to a medicine developer and those subsequently involved in evaluating a marketing authorisation application for the same medicinal product. The Agency shall ensure that at least one of the two rapporteurs for a marketing authorisation application should not have taken part in any pre-submission activities concerning the medicinal product. The reasons for any exceptions shall be documented and published with the European Public Assessment Report.
Amendment 1002 #
Proposal for a regulation
Article 58 – paragraph 4 b (new)
Article 58 – paragraph 4 b (new)
4 b. In addition to providing scientific advice, the Agency shall ensure that scientific guidelines are updated and shall promote public discussion on scientific developments.
Amendment 1024 #
Proposal for a regulation
Article 60 – paragraph 1 – point b
Article 60 – paragraph 1 – point b
(b) are orphan medicinal products and are likely to address a high unmet medical need as referred to in Article 70(1);
Amendment 1101 #
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 1143 #
Proposal for a regulation
Article 70 – paragraph 1 – point b
Article 70 – paragraph 1 – point b
(b) the use of the orphan medicinal product results in a meaningful reduction in disease morbidity or mortality for the relevant patient population.
Amendment 1165 #
Proposal for a regulation
Article 71 – paragraph 2 – point a
Article 71 – paragraph 2 – point a
(a) nineeight years for orphan medicinal products other than those referred to in points (b) and (c);
Amendment 1180 #
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; The market exclusivity for the orphan indication shall not preclude that generics and biosimilars can enter the market for other uses of the medicinal product that are not protected by data and market protection, patents, or supplementary protection certificates.
Amendment 1205 #
Proposal for a regulation
Article 71 – paragraph 2 – point c
Article 71 – paragraph 2 – point c
Amendment 1254 #
Proposal for a regulation
Article 72 – paragraph 2 – subparagraph 2
Article 72 – paragraph 2 – subparagraph 2
Amendment 1281 #
Proposal for a regulation
Article 73 a (new)
Article 73 a (new)
Article73a Reporting of research and development costs from the marketing authorisation holder 1. Where the marketing authorisation holder benefits from the incentives outlined in Article 71 paragraph 2, it shall: (a)upon request, submit to the Commission and/or the competent authorities of the Member States responsible for pricing and reimbursement an electronic report with detailed information on their expenditure in research and development activities related to the medicinal product; (b) make the report available within 30 days from the receipt of the request; (c) publish a summary of the report on the same webpage where the information described in Article 57 of revised Directive 2001/83/EC will be published. The link should be communicated to the Agency; (d) ensure that the electronic report and lay summary are accurate and have been audited by an independent external auditor. 2. The Commission shall adopt implementing acts to lay down the methodology and format in which the information should be reported and published pursuant to paragraph 1.
Amendment 1283 #
Proposal for a regulation
Article 73 b (new)
Article 73 b (new)
Amendment 1425 #
Proposal for a regulation
Article 113 – paragraph 4 – subparagraph 1
Article 113 – paragraph 4 – subparagraph 1
Where the AgencyCommittee on Human Medicinal Products considers it appropriate to set up a regulatory sandbox for medicinal products 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 1435 #
Proposal for a regulation
Article 113 – paragraph 6
Article 113 – paragraph 6
6. The Commission shall, by means of implementingdelegated acts, take a decision on the set up of a regulatory sandbox taking into account the recommendation of the Agency and the sandbox plan pursuant to paragraph 4. Those implementingdelegated acts shall be adopted in accordance with the examination procedure referred to in Article 173(2)5.
Amendment 1441 #
Proposal for a regulation
Article 113 – paragraph 8 – subparagraph 1 – introductory part
Article 113 – paragraph 8 – subparagraph 1 – introductory part
The Commission may, by means of implementingdelegated acts, suspend or revoke a regulatory sandbox at any time. in any of the following cases:
Amendment 1443 #
Proposal for a regulation
Article 113 – paragraph 8 – subparagraph 2
Article 113 – paragraph 8 – subparagraph 2
Those implementingdelegated acts shall be adopted in accordance with the examination procedure referred to in Article 173(2)5.
Amendment 1447 #
Proposal for a regulation
Article 113 – paragraph 9
Article 113 – paragraph 9
9. Where after the Decision to establish the regulatory sandbox in accordance with paragraph 6, risks to health are identified but these risks can be fully mitigated by the adoption of supplementary conditions, the Commission may, after consultation of the Agency, amend its decision by means of implementingdelegated acts. The Commission may also prolong the duration of a regulatory sandbox by means of implementingdelegated acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173(2)5.
Amendment 1448 #
Proposal for a regulation
Article 113 – paragraph 10
Article 113 – paragraph 10
10. This Article shall not exclude the setting up of time limited pilot projects to test different ways of implementing the applicable legislation through delegated acts.
Amendment 1450 #
Proposal for a regulation
Article 114 – paragraph 3
Article 114 – paragraph 3
3. In duly justified cases, the marketing authorisation of a medicinal product developed under the regulatory sandbox may include derogations from the requirements set out in this Regulation and [revised Directive 2001/83/EC]. Those derogations may entail adapted, enhanced, waived or deferred requirements. Each derogation shall be limited to what is apt and strictly necessary to attain the objectives pursued, duly justified and specified in the conditions to the marketing authorisation. Derogations that could compromise patient safety or run contrary to ethical principles in medicine shall not be granted.
Amendment 1485 #
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, where available, of national competent authorities in the Union, 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 1489 #
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 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. The marketing authorisation holder shall submit the prevention plan of a critical medicinal product with the concerned competent authority, following paragraph 9 of Article 127. In addition, and following the provisions of paragraph 1 of Article 132, the prevention plans of those medicinal products included in the Union list of critical medicinal products shall be shared with the Agency. The marketing authorisation holder shall comply with any binding recommendations issued by the competent authority of the Member State and by the MSSG, and take in due consideration any other recommendation.
Amendment 1514 #
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, where this has not already been requested following paragraph 9 of Article 127. The competent authority concerned mayshall set a deadline for the submission of the information requested.
Amendment 1540 #
Proposal for a regulation
Article 121 – paragraph 1 – point b
Article 121 – paragraph 1 – point b
(b) publish information on expected or actual shortages of medicinal products, in cases in which that competent authority has assessed the shortage, on a publicly available websitand user- friendly database;
Amendment 1544 #
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 patients and patient organisations to report shortages of medicinal products;
Amendment 1566 #
Proposal for a regulation
Article 121 a (new)
Article 121 a (new)
Article121a National websites on medicine shortages The website referred to in paragraph 1(b) shall include at least the following information: (a) trade name of the medicinal product and international-non-proprietary name; (b) indication; (c) reasons for the shortage; (d) start and end dates; (e) information for healthcare professionals and patients, including information on alternative treatments.
Amendment 1574 #
Proposal for a regulation
Article 122 – paragraph 4 – introductory part
Article 122 – paragraph 4 – introductory part
4. For the purposes of fulfilling the tasks referred to in Articles 118(1), 123 and 124, the Agency shall ensure the following, in consultation with patients’ organisations and the working party referred to in Article 121(1), point (c):
Amendment 1591 #
Proposal for a regulation
Article 122 – paragraph 6
Article 122 – paragraph 6
6. For the purposes of implementing this Regulation, the Agency shall expand the scope of the ESMP. The Agency shall ensure that, where relevant, data is interoperable between the ESMP, Member States’ IT systems and, where relevant, with other relevant IT systems and databases, without duplication of reporting.
Amendment 1602 #
Proposal for a regulation
Article 123 – paragraph 4
Article 123 – paragraph 4
4. The MSSG mayshall provide recommendations on measures to resolve or to mitigate the critical shortage, in accordance with the methods referred to in Article 122(4), point (d), to relevant marketing authorisation holders, the Member States, the Commission, the representatives of healthcare professionals or other entities.
Amendment 1612 #
Proposal for a regulation
Article 124 – paragraph 2 – subparagraph 2
Article 124 – paragraph 2 – subparagraph 2
For the purposes of this paragraph, the Agency mayshall set a deadline for the submission of the information requested.
Amendment 1614 #
Proposal for a regulation
Article 124 – paragraph 3
Article 124 – paragraph 3
3. The Agency shall establish within its web-portal referred to in Article 104 a publicly available webpagand user-friendly database that provides information on expected or actual critical shortages of medicinal products in cases in which the Agency has assessed the shortage and has provided recommendations to healthcare professionals and patients. The database shall include the information described in article 121a, in addition to the list of Member States affected by each shortage.This webpage shall also provide references to the lists of actualdatabases of shortages published by the competent authorities of the Member State pursuant to Article 121(1), point (b).
Amendment 1615 #
Proposal for a regulation
Article 124 – paragraph 3
Article 124 – paragraph 3
3. The Agency shall establish within its web-portal referred to in Article 104 a publicly available webpage that provides information on actual critical shortages of medicinal products in cases in which the Agency has assessed the shortage and has provided recommendations to healthcare professionals and patients and on critical shortages in the Member States. This webpage shall also provide references to the lists of actual shortages published by the competent authorities of the Member State pursuant to Article 121(1), point (b) and include, to the extent possible, information from other relevant sources and databases identified by the Agency.
Amendment 1640 #
Proposal for a regulation
Article 127 – paragraph 8 a (new)
Article 127 – paragraph 8 a (new)
8 a. Once the competent authority has identified the critical medicinal products, it shall request the corresponding marketing authorisation holders to submit the shortage prevention plan for each product, providing it has not been already requested following paragraph 3. Where necessary, the competent authority shall provide binding and other recommendations on measures to reinforce the prevention plan. Such recommendations may be issued through the MSSG following the procedure described in paragraph 1 of Article 132. The competent authority may request at any time the prevention plans of non- critical medicinal products and shall issue binding or other recommendations where necessary. The competent authority shall set a deadline for the submission by marketing authorisation holders of the requested information.
Amendment 1653 #
Proposal for a regulation
Article 130 – paragraph 1 – subparagraph 1 – introductory part
Article 130 – paragraph 1 – subparagraph 1 – introductory part
The Agency shall, in collaboration with patients’ organisations and the working party referred to in Article 121(1), point (c), ensure the following:
Amendment 1681 #
Proposal for a regulation
Article 131 – paragraph 4 a (new)
Article 131 – paragraph 4 a (new)
4 a. The Agency shall establish a consultation process with patients and consumers in relation to the procedure for establishing the Union list of critical medicines.
Amendment 1684 #
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 provideshall request marketing authorisation holders to submit to the Agency, by a specific deadline, the prevention plans of those medicinal products. The MSSG shall, where necessary, provide binding or other 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. Such measures may include recommendations on diversification of suppliers and inventory management.
Amendment 1696 #
Proposal for a regulation
Article 133 – paragraph 1 – point e a (new)
Article 133 – paragraph 1 – point e a (new)
(e a) maintain contingency stocks of finished medicinal products included in the list referred to in Article 131. Contingency stocks shall be sufficient to meet at least a two-month demand of the medicinal product in each Member State where it has been placed on the market. This obligation shall not preclude the possibility of Member States to adopt complementary measures on safety stocks based on their own lists of medicines considered of major interest.