Marketing authorisation, registration and exemption from marketing authorisation
Veterinary medicinal products that are intended to be placed on the market must go through a corresponding marketing authorisation procedure. Special regulations exist for homeopathic products and for veterinary medicinal products for certain pet animals.
The English website on Veterinary medicines is under construction. Please refer to the German website in case desired information cannot be found here.
An overview
European marketing authorisation procedures
European marketing authorisation procedures for veterinary medicinal products have been established by Regulation (EU) 2019/6: The centralised marketing authorisation procedure and the decentralised procedures.
National authorisation
For a national marketing authorisation, veterinary medicinal products must undergo a marketing authorisation procedure based on Regulation (EU) 2019/6, as well as the Veterinary Medicinal Products Act (TAMG).
Assessment of applications for marketing authorisation
The quality of every veterinary medicinal product is evaluated, as well as the safety and efficacy for each target species. The safety for users, for the environment and, if required, for consumers is also assessed.
Veterinary medicinal products for food-producing animals
Veterinary medicinal products for food-producing animals are subject to specific marketing authorisation requirements to ensure consumer safety when consuming meat, milk, eggs and honey from treated animals.
Exemption from the marketing authorisation requirement
According to Section 4 of the Veterinary Medicinal Products Act (TAMG), veterinary medicinal products for certain pets can be exempted from the obligation to obtain a marketing authorisation under certain conditions.
Parallel trade
Parallel trade in veterinary medicinal products not subject to the centralised marketing authorisation procedure is regulated in Article 102 of Regulation (EU) 2019/6.
Validity of marketing authorisations and re-examination of marketing authorisations for limited markets and in exceptional circumstances
According to Regulation (EU) 2019/6 Art. 5 (2), veterinary medicinal product marketing authorisation is directly valid for an unlimited period of time, except for authorisations according to Art. 23 and Art. 25, which are subject to re-examination.
Marketability and legal status of supply
The marketability and legal status of supply determine whether a veterinary medicinal product is placed on the market and which distribution channels may be used.
Variation of marketing authorisation / registration / exemption
Changes in the composition, manufacture or other documentation of already authorised veterinary medicinal products must be notified to the BVL.
SPC harmonisation
SPC harmonisation is a cross-member state procedure for harmonising the information in the summary of product characteristics for veterinary medicinal products containing the same active substance.
Co-distribution of veterinary medicinal products
In the case of a co-distribution, the co-distributor places a veterinary medicinal product subject to authorisation or registration on the market under his own name on the basis of an agreement under civil law with the marketing authorisation holder.