11 Amendments of Françoise GROSSETÊTE related to 2013/0222(COD)
Amendment 17 #
Proposal for a regulation
Recital 2
Recital 2
(2) The provisions on pharmacovigilance relating to medicinal products of human use laid down in Regulation (EC) No 726/2004 and Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use12 were amended by Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use13 , Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products14 , Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance15 and Regulation (EU) No 1027/2012 of the European Parliament and of the Council of 25 October 2012 amending Regulation (EC) No 726/2004 as regards pharmacovigilance16 . Those amendments only cover medicinal products for human use. Those amendments provide for new pharmacovigilance tasks for the Agency including Union-wide pharmacovigilance procedures, the monitoring of literature cases, the improved information technology tools and the provision of more information to the general public. Furthermore, the pharmacovigilance legislation stipulates that the Agency should be enabled to fund those activities from fees charged to marketing authorisation holders, in addition to public funding provided from the EU budget. New categories of fees should therefore be created to cover the new and specific tasks of the Agency. __________________ 12 JO L 311, du 28.11.2001, p. 67. 13 JO L 348, du 31.12.2010, p. 74. 14 JO L 348, du 31.12.2010, p. 1. 15 16JO L 299, 27.10.2012, p. 1. JO L 299 du 27.10.2012, p. 1. 16 JO L 316, 14.11.2012, p. 38. JO L 316 du 14.11.2012, p. 38.
Amendment 20 #
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, however, 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 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 35 #
Proposal for a regulation
Article 1 – paragraph 4 a (new)
Article 1 – paragraph 4 a (new)
4a. Member States may not impose fees for pharmacovigilance tasks that are already covered by this Regulation.
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 102 #
Proposal for a regulation
Annex – part III – paragraph 1 a (new)
Annex – part III – paragraph 1 a (new)
1a. That fee shall be paid partly from the public funding provided for these new pharmacovigilance tasks and partly by the marketing authorisation holder.