12 Amendments of Stanislav POLČÁK related to 2022/0417(COD)
Amendment 36 #
Proposal for a regulation
Recital 17
Recital 17
(17) The Management Board of the Agency should be empowered to providedecide on further fee reductions for justified reasons of protection of public and animal health. A favourablpositive opinion from the Commission should be mandatory before granting further fee reductions, in order to ensure alignment with Union law and with overall policies of the Union. In addition, in duly justified exceptional cases, for imperative reasons of public or animal health, it should also be possible for the Executive Director of the Agency to reduce certain types of fees on the basis of a critical examination of the situation specific to each case.
Amendment 37 #
Proposal for a regulation
Recital 18
Recital 18
(18) In order to provide flexibility, in particular to adapt to developments in science, the Management Board of the Agency should be enabled to specify working arrangements to facilitate the application of this Regulation, on a duly justified proposal from the Executive Director. In particular, the Management Board should be able to establish due dates and deadlines for payment, payment methods, timetables, detailed classifications, lists of additional fee reductions, and detailed amounts within the limits of an established range. A favourablpositive opinion from the Commission should be mandatory before the proposal is put to the Management Board for adoption, in order to ensure alignment with Union law and with overall policies of the Union.
Amendment 46 #
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
2. The Agency may levy a charge for administrative services it provides, at the request of a third party, if these services are not covered by another fee or charge provided for in this Regulation. The amount of the charge for administrative services shall take into account the workload involved. Its minimum and maximum amount are set out in point 6.4 of Annex IV.
Amendment 51 #
Proposal for a regulation
Article 6 – paragraph 4
Article 6 – paragraph 4
4. On a duly justified proposal from the Executive Director of the Agency, in particular for the protection of public or animal health or for the support of specific types of products or applicants, selected for duly justified reasons, the Management Board of the Agency may grant, following a favourablpositive opinion from the Commission, decide on a total or partial reduction of the applicable amount, in accordance with Article 8.
Amendment 54 #
Proposal for a regulation
Article 6 – paragraph 5
Article 6 – paragraph 5
5. In exceptional circumstances and for imperative reasons of public or animal health, the Executive Director of the Agency may grant, on a case-by-case basis, decide on total or partial reductions for the fees set out in Annexes I, II, III and IV, with the exception of the fees set out in points 6, 15 and 16 of Annex I, points 7 and 10 of Annex II and point 3 of Annex III. Any decision taken pursuant to this Article shall state the reasons on which it is based.
Amendment 56 #
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
The Management Board of the Agency shall, on a justified proposal from the Executive Director and following a favourablpositive opinion from the Commission, establish working arrangements to facilitate the application of this Regulation, including payment methods of the fees and charges levied by the Agency and the mechanism for payment of remuneration to competent authorities of the Member States under this Regulation.
Amendment 58 #
Proposal for a regulation
Article 10 – paragraph 3
Article 10 – paragraph 3
3. EThe competent authorities of the Member States responsible for medicinal products or experts contracted for the procedures of the expert panels on medical devices may provide the Agency with evidence of significant changes in the costs of services provided to the Agency, excluding any effect of inflationary adjustments and any costs for activities that do not constitute a service to the Agency, may be provided by competent authorities of the Member States responsible for medicinal products or by experts contracted for the procedures of the expert panels on medical devices to the Agency. Such information may be provided once per calendar year or less frequently, as a complement to the information provided in accordance with Annex VI. Such evidence shall be based on duly justified and specific official financial information on the nature and the extent of the financial impact on costs for services to the Agency. To that end, the Agency may provide a common format facilitating comparison and consolidation. The competent authorities of the Member States and the experts contracted for the procedures of the expert panels on medical devices to the Agency shall provide such information in the format provided by the Agency, together with any supporting information allowing to verify the correctness of the amounts submitted. The Agency shall review and aggregate that information and shall use it, in accordance with paragraph 6, as a source for the special report provided for in that paragraph.
Amendment 60 #
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. Any adjustment, in line withdue to 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 68 #
Proposal for a regulation
Article 10 – paragraph 7 – introductory part
Article 10 – paragraph 7 – introductory part
7. The special report referred to in paragraph 6 and the recommendations it contains shall be based on the following:
Amendment 69 #
Proposal for a regulation
Article 10 – paragraph 7 – point a
Article 10 – paragraph 7 – point a
(a) continuous monitoring of the information referred to in paragraphs 2 and 3 and of the cost of the activities necessary for the fulfilment of the statutory tasks of the Agency, aimed at identifying significant changes to the cost base of services and activities of the Agency;
Amendment 71 #
Proposal for a regulation
Article 10 – paragraph 7 – point b
Article 10 – paragraph 7 – point b
(b) objective and verifiable information and quantification that directly supports the relevance of the recommended adjustments.
Amendment 84 #
Proposal for a regulation
Article 13 – paragraph 3
Article 13 – paragraph 3
3. The delegation of power referred to in Article 11(1) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect on the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.