|VMPs auhorised by the centralised procedure in EU|
|Written by Leona Nepejchalová|
In the European Union (EU), a company that wishes to bring a veterinary medicine to the market may submit a single application to the EMEA for a 'marketing authorisation' (licence) that is valid simultaneously in all EU Member States, plus Iceland, Liechtenstein and Norway. This is called the 'centralised (or 'Community') authorisation procedure', and is mandatory for certain types of veterinary medicines and optional for others. (The precise scope is set out in Annex of Regulation (EC) No 726/2004.)
Instruction for finding summaries of product characteristics for centrally authorised veterinary medicinal products
The SPCs can be obtained from the Commission's home page - Enterprise and Industry DG - Pharmaceuticals - Community register
SPCs and relevant information on products are also published on EMA web page.
|Last Updated on Thursday, 02 March 2017 08:58|