12 Amendments of Antonyia PARVANOVA related to 2013/0222(COD)
Amendment 18 #
Proposal for a regulation
Recital 7
Recital 7
(7) Fees referred to in this Regulation should be transparent, fair and proportionate to the work carried out. Information on these fees should be publicly available.
Amendment 24 #
Proposal for a regulation
Recital 12
Recital 12
(12) The work carried out at Union level in respect of the assessment of non- interventional post- authorisation safety studies imposed by an authority and of which the protocol has been endorsed by the Pharmacovigilance Risk Assessment Committee, involves the supervision of these studies, starting from the assessment of the draft protocol, and is not limited to the assessment of the final study reports. Therefore, the fee levied for this procedure in respect of studies that have been finalised should cover all the work relating to the study. In order to avoid double charging, marketing authorisation holders who are charged the fee for the assessment of non-interventional post-authorisation safety studies imposed by an authority, should be exempted from any other fee charged by a competent authority for the submission of those studies.
Amendment 28 #
Proposal for a regulation
Recital 14 a (new)
Recital 14 a (new)
(14a) Marketing authorisation holders belonging to the same mother company or group of companies or having concluded agreements or exercising concerted practices concerning the placing on the market of the relevant medicinal product should be considered as one entity (i.e. a 'single marketing authorisation holder').
Amendment 31 #
Proposal for a regulation
Recital 16
Recital 16
(16) Generic medicinal products, medicinal products authorised under the provisions relating to well-established medicinal use, authorised homeopathic medicinal products and authorisemedicinal products authorised in the Union for at least 10 years and authorised homeopathic and herbal medicinal products should be subject to a reduced annual flat fee as those products generally have a well-established safety profile. However, in cases where these products are part of any of the Union-wide pharmacovigilance procedures, the full fee should be charged in view of the work involved. As the legislation on pharmacovigilance encourages the conduct of joint post authorisation safety studies, marketing authorisation holders should share the applicable fee in case a joint study is submitted.
Amendment 38 #
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 48 #
Proposal for a regulation
Article 4 – paragraph 6 a (new)
Article 4 – paragraph 6 a (new)
6a. Marketing authorisation holders who are charged the fee under this Article shall be exempted from any other fee charged by a competent authority for the assessment referred to in paragraph 1, including, but not limited to, fees for variations submitted in accordance with Articles 107g(2) and (4) of Directive 2001/83/EC.
Amendment 51 #
Proposal for a regulation
Article 5 – paragraph 6
Article 5 – paragraph 6
6. Marketing authorisation holders who are charged the fee under this Article shall be exempted from any other fee charged by a competent authority for the submission of studies referred to in paragraph 1, including, but not limited to, fees for variations submitted in accordance with Articles 107p(2) and 107q(2) of Directive 2001/83/EC.
Amendment 54 #
Proposal for a regulation
Article 6 – paragraph 6 a (new)
Article 6 – paragraph 6 a (new)
6a. Marketing authorisation holders who are charged the fee under this Article shall be exempted from any other fee charged by a competent authority for the assessment referred to in paragraph 1, including, but not limited to, fees for variations submitted in accordance with Article 34(3) and Article 35 of Directive 2001/83/EC.
Amendment 59 #
Proposal for a regulation
Article 7 – paragraph 5
Article 7 – paragraph 5
5. A reduced annual flat fee, as laid down in Part IV of the Annex, shall apply in respect ofto generic medicinal products referred to in Article 10(1) and Article 10a of Directive 2001/83/ECmedicinal products authorised under the provisions relating to well-established medicinal use referred to in Article 10a of Directive 2001/83/EC, all products authorised in the Community for at least 10 years, and in respect of authorised homeopathic medicinal products and authorised herbal medicinal products, as defined respectively in Article 1(5) and Article 1(30) of Directive 2001/83/EC.
Amendment 62 #
Proposal for a regulation
Article 8 – paragraph 3
Article 8 – paragraph 3
3. Any marketing authorisation holder claiming to be entitled to a reduced annual flat fee under Article 7(5) shall make a declaration to that effect to the Agency; the Commission shall publish guidelines on how this declaration is to be formulated by the marketing authorisation holder. The Agency shall apply the reduction on the basis of that declaration where the required conditions are met,. Where the declaration is made by the marketing authorisation holder after the receipt of the invoice from the Agency, the declaration shall be done within 30 calendars days from the receipt of that invoice.
Amendment 80 #
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 annuallyin the annual report delivered to the European Parliament, the Council, the Commission, the European Economic and Social Committee, the Court of Auditors and the Member States according to Article 65 paragraph 10 of Regulation (EC) No 726/2004 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 Agency shall also 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 85 #
Proposal for a regulation
Article 16 – paragraph 2
Article 16 – paragraph 2
2. Any amendments to the amounts shall be based on an transparent 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).