Activities of Nicola CAPUTO related to 2014/0256(COD)
Plenary speeches (2)
Authorisation and supervision of veterinary medicinal products (A8-0035/2016 - Claudiu Ciprian Tănăsescu) IT
Veterinary medicinal products - Authorisation and supervision of veterinary medicinal products (debate) IT
Shadow opinions (1)
OPINION on the proposal for a regulation of the European Parliament and of the Council amending 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
Amendments (6)
Amendment 16 #
Proposal for a regulation
Recital 6
Recital 6
(6) In order to ensure uniform conditions for the implementation of Regulation (EC) No 726/2004, implementing powers should be conferred on the Commission to adopt implementing acts in relation to marketing authorisations for medicinal products for human and veterinary use. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council8. ___________ 8 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
Amendment 17 #
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Article 1 – paragraph 1 – point 3
Regulation (EC) No 726/2004
Article 2 – point 1
Article 2 – point 1
The definitions laid down in Article 1 of Directive 2001/83/EC and in Regulation (EU) ... of the European Parliament and of the Council on veterinary medicinal products (2014/0257(COD) shall apply for the purposes of this Regulation.
Amendment 21 #
Proposal for a regulation
Article 1 – paragraph 1 – point 10 a (new)
Article 1 – paragraph 1 – point 10 a (new)
Regulation (EC) No 726/2004
Article 55 – paragraph 2
Article 55 – paragraph 2
(10a) Article 55(2) is replaced by the following: ‘The Agency shall be responsible for coordinating the existing scientific resources put at its disposal by Member States for the evaluation, supervision and pharmacovigilance of medicinal products for human and veterinary use.’
Amendment 24 #
Proposal for a regulation
Article 1 – paragraph 1 – point 11
Article 1 – paragraph 1 – point 11
Regulation (EC) No 726/2004
Article 57 – paragraph 2 – subparagraph 1
Article 57 – paragraph 2 – subparagraph 1
2. The database provided for in paragraph 1(l) shall include the summaries of product characteristics, the patient or user package leaflet and the information shown on the labelling. The database shall be developed in stages, priority being given to medicinal products authorised under this Regulation and those authorised under Chapter 4 of Title III of Directive 2001/83/EC. The database shall subsequently be extended to include any medicinal product for human use authorised in the Union.’;
Amendment 29 #
Proposal for a regulation
Article 1 – paragraph 1 – point 15
Article 1 – paragraph 1 – point 15
Regulation (EC) No 726/2004
Article 67 – paragraph 3 – subparagraph 1
Article 67 – paragraph 3 – subparagraph 1
The Agency’s revenue shall consist of a contribution from the Union, fees paid by undertakings for obtaining and maintaining Union marketing authorisations and for other services provided by the Agencyfor medicinal products for human and veterinary use, and for other services provided by the Agency under this Regulation or Regulation (EU) ... of the European Parliament and of the Council on veterinary medicinal products (2014/0257 (COD), or by the coordination group as regards the fulfilment of its tasks in accordance with Articles 107c, 107e, 107g, 107k and 107q of Directive 2001/83/EC and charges for other services provided by the Agency.
Amendment 31 #
Proposal for a regulation
Article 1 – paragraph 1 – point 16
Article 1 – paragraph 1 – point 16
Regulation (EC) No 726/2004
Article 70
Article 70