• In compliance with the Act No 378/2007 on Pharmaceuticals, veterinary medicinal products are subject to the marketing authorisation in the Istitute for State Control of Veterinary Biologicals and Medicaments (national, mutual recognition and decentralised procedures) or subject to the Community marketing authorisation according to the Regulation (EC) No 726/2004.

ISCVBM grants a marketing authorisation if requirements for the marketing authorisation specified in the Act on Pharmaceuticals and the Regulation No 228/2008 which are in compliance with the EU legislation (Directive 2004/28/EC) are fulfilled. A marketing authorisation is granted for a period of 5 years and is renewable upon application three months before expiry.Once renewed, the marketing authorisation shall normally be valid for an unlimited period oftime. However, on justified grounds relating to pharmacovigilance, the ISCVBM may decide to proceed with one additional five-year renewal, after which the authorisationwill become valid for unlimited period of time.

• Throughout the life of a veterinary medicinal product, the marketing authorisation holder is responsible for the product which is placed on the market and is also requiredto take into account technical and scientific progress, and to make anyamendments that may be required to enable the veterinary medicinal product to bemanufactured and checked by means of generally accepted scientific methods.Such amendments may involve administrative or more substantial changes. The  marketing authorisation holder shall submit a notification or an application for the approval of a variation to the terms of a marketing authorisation to the ISCVBM before its implementation.