Čeština (Česká republika)English (United Kingdom)


Home Authorisation & Approval Marketing authorisation of VMPs List of VMPs Authorised by the Community centralised procedure
VMPs auhorised by the centralised procedure in EU PDF Print E-mail
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

  • for veterinary medicinal products there is an alphabetical overview of products
    • By clicking on the name of the product desired, on overview appears, which includes the authorised SPCs in 19 languages.
    • If the SPC is not present, it can be requested via direct application to the Commission.
    • The documents are .pdf-files and these can be downloaded with the help of Adobe Acrobat Reader.

SPCs and relevant information on products are also published on EMA web page.

Last Updated on Thursday, 02 March 2017 08:58