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Guideline on Common Baltic Package and Common Baltic Package Procedure for Veterinary Medicinal Products
17.09.2018
In order to improve the process of multilingual packaging and use of Common Baltic Package Procedure, created in November 2016, Baltic regulatory agencies have updated the Guideline on Common Baltic Package and Common Baltic Package Procedure. Updated guideline and procedure has been signed in August 2018 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
LV: vzr@pvd.gov.lv
State Agency of Medicines
