Order No. 47 of the National Sanitary Veterinary and Food Safety Authority validating the Veterinary and Sanitary Regulation regarding the procedure for solving the requests for the transfer of marketing authorization in Romania of veterinary medicinal products authorized in conformity with the national procedure.

This Regulation sets out the procedure for examining and resolving applications for the transfer of marketing authorization for veterinary medicinal products authorized by the national marketing procedure. The transfer of the marketing authorization may be requested only for veterinary medicinal products for which there is a valid marketing authorization issued by the Institute for the Control of Biological Products and Veterinary Medicinal Products. The transfer of the marketing authorization shall involve the replacement of the current marketing authorization holder with a new holder in Romania or in another Member State of the European Union. The transfer of the marketing authorization shall take place in the following cases: (a) in the case of a merger/acquisition, whereby the marketing authorization holder is taken over by another company and ceases to exist as a separate legal entity; (b) a company sells the veterinary medicinal product and the rights to the veterinary medicinal product to another company; and (c) in other situations provided by law. The transfer of the marketing authorization is valid from the date of issuance by the Institute for Control of Biological Products and Veterinary Medicines of the marketing authorization on behalf of the new holder. Annex 1 contains standard transfer application form. Annex 2 contains the list of documentation requested for transfer.