Requirements for product information exist at both, the European and national levels.

Name of the medicinal product

According to the RIS - BGBLA_2025_II_10 - Bundesgesetzblatt authentisch ab 2004, Article 2 §3, the name must include the target species or the addition “für Tiere”.

Prescription status

The prescription status is subject to national regulations. Detailed information can be found at Prescription of medicines - BASG.

High-quality national translations

All submitted texts must provide a high-quality translation in accordance with the BEST PRACTICE GUIDE for the submission of high quality national translations for veterinary medicines (EMA/CMDv/5098/2022) or will otherwise be rejected by the BASG.

Shared German-language (“multi-country”) product information of VMPs for AT, BE and/or DE

If the marketing authorisation holder intends to provide harmonised product literature of VMP via MRP/DCP in German-language for Austria, Belgium and/or Germany, please refer to the “Guidance for harmonisation of the German language translation of product information for veterinary medicinal products in MRP/DCP” for applying of a coordinated text review between the concerned national competent authorities: This AT-BE-DE-Guidance and detailed information can be found at: Shared (“multi-country”) packaging of VMP for AT, BE and/or DE

Electronic package leaflet

Please find detailed information at Package Leaflet - BASG.