11 Amendments of Marina YANNAKOUDAKIS related to 2013/0222(COD)
Amendment 19 #
Proposal for a regulation
Recital 8
Recital 8
(8) This Regulation should only refer to fees which are to be levied by the Agency, whereas the competence to decide on possible fees levied by the competent authorities of the Member States should remain with the Member States. Marketing authorisation holders should not be charged twice for the same pharmacovigilance activity. Member States should therefore not levy fees for the activities which are covered by this Regulation.
Amendment 33 #
Proposal for a regulation
Article 1 – paragraph 1 a (new)
Article 1 – paragraph 1 a (new)
1a. Registered homeopathic and herbal medicinal products shall be exempt from the scope of this regulation.
Amendment 36 #
Proposal for a regulation
Article 2 – paragraph 1 – point 1
Article 2 – paragraph 1 – point 1
1. ‘'Chargeable unit’' means each individual entry in the database referred to in Article 57(1)(l) of Regulation (EC) No 726/2004 based on information from the list of all medicinal products for human use authorised in the Union referred to in Article 57(2) thereofa unit defined by the following data set from the medicinal products information included in the database referred to in Article 57(1)(l) of Regulation (EC) No 726/2004: (a) marketing authorisation holder; (b) country where the marketing authorisation is valid; (c) active ingredient(s); (d) pharmaceutical form.
Amendment 60 #
Proposal for a regulation
Article 7 – paragraph 7
Article 7 – paragraph 7
7. The Agency shall levy the annual flat fee by issuing invoices to marketing authorisation holders at the latest on 31 January of every calendar year for that calendar year. Fees due under this Article shall be paid within 30 calendar daysthe timeframe set in Directive 2011/7/EC from the date on which the invoice is received by the marketing authorisation holder, or in exceptional circumstances through an independently agreed timeframe negotiated between the agency and the marketing authorisation holder.
Amendment 66 #
Proposal for a regulation
Article 8 – paragraph 5
Article 8 – paragraph 5
5. Where a marketing authorisation holder claiming or having claimed to be entitled to a reduction of or an exemption from fees under this Regulation fails to demonstrate that it is entitled to such a reduction or exemption, the full amount of the fee laid down in the Annex shall be increased by 10% and the Agency shall levy the resulting full applicable amount or, as appropriate, the balance to the resulting fullthen be applicable amount.;
Amendment 75 #
Proposal for a regulation
Article 9 – paragraph 5
Article 9 – paragraph 5
5. The remuneration shall be paid in accordance with the written contract referred to in the first subparagraph of Article 62(3) of Regulation (EC) No 726/2004 and within the timeframe set in Directive 2011/7/EC. Any bank charges related to the payment of that remuneration shall be borne by the Agency.
Amendment 77 #
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
The Agency shall, when producing an estimate of the overall expenditure and income for the following financial year in accordance with Article 67(6) of Regulation (EC) No 726/2004, include detailed information on income from fees relating to pharmacovigilance activities. This information shall distinguish between the annual flat fee and the fees for each procedure referred to in Article 3(a) which will be based on the number of chargeable unit entries in the database. The Agency shall also provide specific analytical information on its revenue and expenditure related to pharmacovigilance activities, allowing to distinguish between the annual flat fee and each of the fees for procedures referred to in Article 3(a).
Amendment 78 #
Proposal for a regulation
Article 15 – paragraph 2
Article 15 – paragraph 2
2. The Executive Director of the Agency shall provide the Commission and, the Management Board, the Court of Auditors and the Member States annually with information on the components that may have a bearing on the costs to be covered by the fees provided for in this Regulation. This information shall include a cost breakdown related to the previous year and a forecast for the following year. The Executive Director of the Agency shall also openly publish this overview in its public annual report. The Executive Director of the Agency shall also provide the Commission and the Management Board once per year with the performance information set out in Part V of the Annex based on the performance indicators referred to in paragraph 3.
Amendment 82 #
Proposal for a regulation
Article 16 – paragraph 1
Article 16 – paragraph 1
1. The Commission shall be empowered to adopt delegated acts to amend Parts I to V of the Annex. to take account of inflationary fluctuations only. Increasing or decreasing the fees shall be decided as part of the overall review of the Agency´s fees regime which has been planned for early 2015.
Amendment 83 #
Proposal for a regulation
Article 16 – paragraph 2
Article 16 – paragraph 2
2. Any amendments to the amounts shall be based on a transparent and open evaluation of the costs of the Agency and the costs of the assessments provided by the rapporteurs as laid down in Article 9 or on the monitoring of the inflation rate referred to in Article 15(4).
Amendment 104 #
Proposal for a regulation
Annex – part III– paragraph 3 – subparagraph 2 – point ii
Annex – part III– paragraph 3 – subparagraph 2 – point ii
(ii) subsequently applying the reduction laid down in paragraph 2 of Part III of this Annex and the exemption referred to in Article 1(3), where relevant.