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.

Electronic package leaflet

Please find detailed information at Package Leaflet - BASG.