In order to facilitate the availability of veterinary medicinal products and provide assistance to Applicants and Marketing Authorisation Holders in creating common multilingual Baltic packages for veterinary medicinal products, official agreement on the Guideline on Common Baltic Package and Common Baltic Package Procedure for veterinary medicinal products was signed by the heads of Baltic regulatory agencies: Estonian Agency of Medicines, Latvian Food and Veterinary Service and Lithuanian National Food And Veterinary Risk Assessment Institute.
The guideline outlines general principles, as well as specific requirements for common Baltic packages. The procedure has been specially designed for labelling harmonisation, which is a prerequisite for obtaining the common Baltic package for a veterinary medicinal product. During this procedure the Marketing Authorisation Holder will have to communicate with only one agency (Reference Baltic State) acting on behalf of all regulatory authorities involved in the common package procedure.
Contact points for information:
Last updated: 07.03.2022