2 Amendments of Daniel BUDA related to 2014/0256(COD)
Amendment 11 #
Proposal for a regulation
Recital 1
Recital 1
(1) Directive 2001/82/EC of the European Parliament and of the Council5 and Regulation (EC) 726/2004 of the European Parliament and of the Council6 constituted the Union regulatory framework for the manufacture, authorisation and distribution of veterinary medicinal products. In the light of the experience acquired and following the assessment by the Commission of the functioning of the internal market for veterinary medicinal products, the regulatory framework for veterinary medicinal products has been reviewed, and Regulation (EU) No […] of the European Parliament and of the Council7 laying down procedures for the authorisation and supervision of veterinary medicinal products has been adopted, with a view to harmonisation of the laws of the Member States. ___________ 5 Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1). 6 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). 7 Regulation … of the European Parliament and of the Council of … … … on veterinary medicinal products (OJ L …, … … …, p. …).
Amendment 12 #
Proposal for a regulation
Recital 4
Recital 4
(4) As a consequence of the entry into force of the Treaty of Lisbon, the powers conferred on the Commission under Regulation (EC) No 726/2004 should be aligned to Articles 290 and 291 of the Treaty on the Functioning of the European Union. In order to supplement or amend certain non-essential elements of Regulation (EC) No 726/2004, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission in respect of amending the Annex with regard to technical and scientific progress so as to facilitate the placing on the market of new medicinal products, determining the situations in which post- authorisation efficacy studies may be required, laying down provisions and requirements for granting marketing authorisations subject to certain specific obligations, establishing procedures for the examination of applications for variations to the terms of marketing authorisations and for the examination of applications for the transfer of marketing authorisations and laying down the procedure for investigating the infringements and the imposition of fines or periodic penalty payments to the holders of marketing authorisations granted under this Regulation, the maximum amounts of these penalties as well as the conditions and methods for their collection.