Regulation on modifications to the marketing authorization for veterinary medicinal products.

This Regulation establishes the procedure for modification or amendment of the previously granted marketing authorization for veterinary medicinal products, here in relation to the types and reasons of granted authorizations as listed in article 1, including the list of reference European Union documents and Directives. European Commission related guidelines are laid down in article 4. An application for the extension of a marketing authorization shall be assessed in accordance with the same procedure as for the initial marketing authorization to which it applies (article 17). Urgent safety restraints and related issues are listed in article 19. Modifications and/or procedures for additions to the marketing authorization for specific veterinary medicinal products are laid down in articles 20 and 21.
The Annex is also part of this publication (containing procedural indications and classification of amendments).