Activities of Kateřina KONEČNÁ related to 2022/0417(COD)
Shadow reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council of the Council on fees and charges payable to the European Medicines Agency, amending Regulation (EU) 2017/745 of the European Parliament and of the Council and repealing Council Regulation (EC) No 297/95 and Regulation (EU) 658/2014 of the European Parliament and of the Council
Amendments (8)
Amendment 41 #
Proposal for a regulation
Recital 28 a (new)
Recital 28 a (new)
(28a) Transparency of clinical trial protocols is key to promoting research in the Union. Researchers need access to detailed information on trial design, including measures taken to minimise bias, statistical methods, and dosage regimes in order to fully interpret trial outcomes. Information in the EU database should be public, unless there are specific reasons why a piece of information should not be published. The agency shall disclose unredacted clinical trial protocols for Phase II and Phase III trials on CTIS at the same time as the summary results of the related trials are published on CTIS.
Amendment 62 #
Proposal for a regulation
Article 10 – paragraph 6 – introductory part
Article 10 – paragraph 6 – introductory part
6. At the earliest on [OP: please insert date 31 years after the date of application] and at three-year intervals thereafter, the Executive Director of the Agency may, where considered relevant in view of Article 11(2), and after consultation of the Management Board of the Agency, provide the Commission with a special report outlining, in an objective, fact-based and sufficiently detailed manner, justified recommendations:
Amendment 65 #
Proposal for a regulation
Article 10 – paragraph 6 – point a a (new)
Article 10 – paragraph 6 – point a a (new)
Amendment 78 #
Proposal for a regulation
Article 11 – paragraph 1 – point c
Article 11 – paragraph 1 – point c
Amendment 79 #
Proposal for a regulation
Article 11 – paragraph 1 – point e
Article 11 – paragraph 1 – point e
Amendment 81 #
Proposal for a regulation
Article 11 – paragraph 2 a (new)
Article 11 – paragraph 2 a (new)
2a. In any revision of the Annexes by means of a delegated act the percentage distribution of fees between the national competent authorities and the Agency shall be maintained.
Amendment 85 #
Proposal for a regulation
Article 13 – paragraph 4
Article 13 – paragraph 4
4. Before adopting and while drafting or preparing a delegated act, the Commission shall consultduly take into account the opinion delivered by experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.
Amendment 89 #
Proposal for a regulation
Annex I – point 3 – point 3.4
Annex I – point 3 – point 3.4
3.4. A fee of EUR 575 0677 800 shall apply to an application for a biological medicinal product which is similar to a reference biological product pursuant to Article 10(4) of Directive 2001/83/EC. That fee shall cover all strengths, all pharmaceutical forms and all presentations submitted in the same application. The remuneration shall be EUR 236 583 800 for the rapporteur and EUR 151 782 000 for the co-rapporteur.