In accordance with Article 7 of Regulation (EU) 2019/6 (1) and (2), veterinary medicinal products (VMPs) may be made available on the market in multi-lingual (two or more official languages) and multi-country (same official language applicable for two or more Member States) packaging, provided that the same information appears in the product information (summary of the product characteristics, labelling and package leaflet) of the VMP.

The use of multi-lingual and/or multi-country packaging is an important tool for increasing and maintaining the availability of VMPs on EU markets, especially on so-called “small markets”.
To facilitate the supply of VMPs with multi-country packaging on German-speaking markets, the Member States Austria, Germany and Belgium have jointly elaborated the “Guidance for harmonisation of the German language translation of product information for VMPs in MRP/DCP”. 

This AT-BE-DE-Guidance is intended to assist applicants in the preparation and maintenance of shared German-language product information for VMPs and to facilitate a coordinated linguistic review process of the German translations regarding completeness and correctness between the national competent authorities involved. 

To apply for multi-country packaging of a VMP in German-language between AT, BE and/or DE, please submit the relevant filled request form of Annex 1 of the AT-BE-DE-Guidance together with the German translations simultaneously to all national competent authorities concerned: