Activities of Tudor CIUHODARU 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 (12)
Amendment 48 #
Proposal for a regulation
Article 6 – paragraph 3
Article 6 – paragraph 3
3. Where the applicant or marketing authorisation holder may also benefit from another reduction provided for in Union legislation, only the reduction that is the most favourable to the applicant or marketing authorisation holder shall apply. For all generic and biosimilar medicines, the reduction in fees and charges will be between 30% and 50%.
Amendment 59 #
Proposal for a regulation
Article 10 – paragraph 5
Article 10 – paragraph 5
5. The Commission shall monitor the inflation rate, measured by means of the Harmonised Index of Consumer Prices published by Eurostat pursuant to Regulation (EU) No 2016/792, in relation to the amounts of fees, charges and remuneration set out in the Annexes to this Regulation. The monitoring exercise shall take place no earlier than [OP: please insert date one year after the date of application of this Regulation], and thereafter on an annual basis, based on an external audit submitted to the European Parliament. Any adjustment, in line with inflation, to fees, charges and remuneration established in accordance with this regulation shall become applicable, at the earliest, on 1 January of the calendar year following the calendar year in which the monitoring exercise took place.
Amendment 61 #
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 3 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, on the basis of an external audit submitted to the Subcommittee on Public Health of the European Parliament, justified recommendations:
Amendment 70 #
Proposal for a regulation
Article 10 – paragraph 7 – point b
Article 10 – paragraph 7 – point b
(b) objective and verifiable information and quantification, based on an external audit submitted to the European Parliament, that directly supports the relevance of the recommended adjustments.
Amendment 73 #
Proposal for a regulation
Article 10 – paragraph 8
Article 10 – paragraph 8
8. The Commission may request any clarification or further substantiation, based on an external audit submitted to the European Parliament, of the report and its recommendations, if considered necessary. Following such a request, the Agency shall without undue delay provide the Commission with an updated version of the report which addresses any comments made and questions raised by the Commission.
Amendment 75 #
Proposal for a regulation
Article 10 – paragraph 9 – point c
Article 10 – paragraph 9 – point c
(c) in the case there is clear and compelling evidence, based on an external audit submitted to the European Parliament, of significant changes in the costs or the cost-revenue balance of the Agency, including costs for cost-based remuneration to competent authorities of the Member States.
Amendment 83 #
Proposal for a regulation
Article 13 – paragraph 2
Article 13 – paragraph 2
2. The power to adopt delegated acts referred to in Article 11(1) shall be conferred on the Commission for a period of 2.5 years from [tbc] 20[xx]. The Commission shall draw up a report in respect of the delegation of power not later than 6 months before the end of the 2.5- year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than 3 months before the end of each period.
Amendment 88 #
Proposal for a regulation
Annex I – point 3 – point 3.4
Annex I – point 3 – point 3.4
3.4. A fee of EUR 575450 000 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 236 500 for the rapporteur and EUR 151 700 for the co-rapporteur.
Amendment 90 #
Proposal for a regulation
Annex I – point 3 – point 3.5
Annex I – point 3 – point 3.5
3.5. A fee of EUR 624 3400 000 shall apply to an application for a marketing authorisation for a medicinal product pursuant to Article 10a 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 160 600 for the rapporteur and EUR 149 400 for the co-rapporteur.
Amendment 94 #
Proposal for a regulation
Annex I – point 7 – paragraph 2
Annex I – point 7 – paragraph 2
A fee of EUR 29 7014 850 shall apply to a request for scientific advice from the Committee on Herbal Medicinal Products related to traditional herbal medicinal products. The remuneration shall be EUR 4 100 for the rapporteur.
Amendment 101 #
Proposal for a regulation
Annex I – point 12 – paragraph 2
Annex I – point 12 – paragraph 2
A fee of EUR 16 88 400 shall apply to an application for the designation of an orphan medicinal product pursuant to Regulation (EC) No 141/2000. Such fee shall be waived in full. The remuneration shall be EUR 1 500 for the rapporteur.
Amendment 108 #
Proposal for a regulation
Annex V – point 8 – paragraph 2 – introductory part
Annex V – point 8 – paragraph 2 – introductory part
A fee reduction of 250% shall apply to the annual pharmacovigilance fee set out in section 3 of Annex III for the following medicinal products: