11 Amendments of Tiemo WÖLKEN related to 2022/0417(COD)
Amendment 31 #
Proposal for a regulation
Recital 15
Recital 15
(15) In line with union policies, it is appropriate to provide for reductions of the fees to support specific sectors and applicants or marketing authorisation holders, such as micro-, small- and medium-sized enterprises (SMEs), non- profit-organisations or to respond to specific circumstances, such as products responding to recognised public health or animal health priorities or veterinary medicinal products intended for a limited market authorised in accordance with Article 23 of Regulation (EU) 2019/6.
Amendment 34 #
Proposal for a regulation
Recital 17
Recital 17
(17) The Management Board of the Agency should be empowered to provide further fee reductions for justified reasons of protection of public and animal health. A favourable 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. For transparency purposes, the Agency should make information on the authorised decisions for further fee reductions publicly available on its website. The information should include information on the recipients and details that duly justify the decision for further reductions. 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. The Agency should ensure that these decisions of the Executive Director are made publicly available on its website and detail the reasons justifying the decisions.
Amendment 49 #
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 favourable opinion from the Commission, a total or partial reduction of the applicable amount, in accordance with Article 8. The Agency shall make information on these reductions publicly available on the Agency’s website detailing the duly justified reasons for the reduction.
Amendment 52 #
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, 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. The Agency shall make information on these decisions by the Executive Director publicly available on the Agency’s website detailing the duly justified reasons for the reduction.
Amendment 57 #
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
1. The amounts set out in the annexes shall be published on the website of the Agency and shall be updated in line with any changes.
Amendment 63 #
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 mayshall, 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 64 #
Proposal for a regulation
Article 10 – paragraph 6 – point a a (new)
Article 10 – paragraph 6 – point a a (new)
(aa) to adapt any fee, charge or remuneration, or introduce a new fee, charge or remuneration following a change in the statutory tasks of the Agency resulting in a significant change in costs;
Amendment 66 #
Proposal for a regulation
Article 10 – paragraph 6 – point b a (new)
Article 10 – paragraph 6 – point b a (new)
(ba) to adapt the specification of activities for which the Agency collects fees or charges to changing conditions and requirements.
Amendment 67 #
Proposal for a regulation
Article 10 – paragraph 6 a (new)
Article 10 – paragraph 6 a (new)
6a. For transparency purposes the special report shall be made publicly available without delay on the Agency’s website. The special report shall include information on the stakeholders consulted in the preparation of the special report.
Amendment 74 #
Proposal for a regulation
Article 10 – paragraph 9 – introductory part
Article 10 – paragraph 9 – introductory part
9. The time interval to the first special report as well as the reporting time interval referred to in paragraph 6 may be shortened in any of the following situations:
Amendment 106 #
Proposal for a regulation
Annex V – point 1 – point 1.1 – point 1.1.3
Annex V – point 1 – point 1.1 – point 1.1.3
1.1.3. for a micro enterprise and non- profit organisation, a reduction of 100 % shall apply to the fees set out in points 1.1.1. and 1.1.2.