Regulation amending the Regulation No 60 of 9 May 2006 on the data requirements contained in the documentation for the authorization of veterinary medicinal products.

This Regulation amends several provisions part of the Regulation No 60 of 9 May 2006 on the data requirements contained in the documentation for the authorization of veterinary medicinal products, published by the Official Gazette of the Republic of Bulgaria 50/2006.
Changes are related to the introduction of the requirements contained in the following documents: Regulation No. 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency; Commission Regulation (EC) No 1084/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorization for medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State; Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonization of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances; and new issues on vaccine antigen master files that have to be separated from the rest of the application dossier.
Also large sections of the Annex are updated and printed among this publication.