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
- Usage of the electronic application forms (eAF)
- Orientation points for a smooth electronic submission
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.
Advice for post-approval procedures
- CEP - Certificate of Suitability of Monographs of the European Pharmacopoeia
- Variation of marketing authorisation / registration / exemption
Advice on the use of the product information templates for veterinary medicines
Advice on procedures for the exemption from the need to obtain a marketing authorisation according to section 4 TAMG
Current forms and templates for application can also be found here.