Procedural Guidance

Here, pharmaceutical companies can access general information on marketing authorisations and their follow-up procedures.

Before a veterinary medicinal product can be placed on the market, a marketing authorisation must be granted in accordance with article 5(1) of Regulation (EU) 2019/6.

In Germany, the Federal Office of Consumer Protection and Food Safety (BVL) is the competent authority for the authorisation of veterinary medicinal products.

For all submissions related to marketing authorisations, please use the following address:

Bundesamt für Verbraucherschutz und Lebensmittelsicherheit
-Tierarzneimittelregistratur -
Dienstsitz Berlin - Gerichtstraße
Gerichtstraße 49
13347 Berlin

Guidance on electronic applications

Obtaining a marketing authorisation

In order to obtain a marketing authorisation, it is necessary to submit a dossier with the required documents according to Annex II of Regulation (EU) 2019/6. The structure of a dossier, which is harmonised within the European Union (EU), is also described in Annex II of Regulation (EU) 2019/6. As part of the authorisation procedure, the product literature of the candidate veterinary medicinal product is also assessed.

For further information on the requirements and the process of various marketing authorisation procedures, in particular the decentralised European marketing authorisation procedures, please refer to the website of the “Coordination Group for the Mutual Recognition of and Decentralised Procedures - Veterinary" as well as the "Guideline on eSubmissions for Veterinary products". The latter is also valid for national marketing authorisation procedures.