European marketing authorisation procedures
- Centralised procedure
- Decentralised procedure
- Mutual Recognition Procedure
- Subsequent Recognition Procedure
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.
The BVL experts participate in the Scientific Committee for Veterinary Medicinal Products (CVMP) of the EMA and its working groups, as well as the Coordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMDv).
In recent years, the number of applications for the decentralised marketing authorisation procedures has increased.
Centralised procedure
For centralised marketing authorisation procedures, the application is handled by the EMA's Scientific Committee for Medicinal Products for Veterinary Use (CVMP). A centralised marketing authorisation procedure is mandatory for some veterinary medicinal products, e.g. new substances produced by certain biotechnological processes (see also Article 42 (2) and (3) of Regulation (EU) 2019/6). For other veterinary medicinal products, it can be used optionally.
More Information on the centralised marketing authorisation procedure can be found here.
Decentralised procedure
In the decentralised procedure, no prior national marketing authorisation is required. Instead, the pharmaceutical company simultaneously applies for marketing authorisation in all the EU Member States of their choosing, with one Member State taking the lead in this procedure as the so-called Reference Member State.
More Information on the decentralised procedure can be found here.
Mutual Recognition Procedure
In the mutual recognition procedure (MRP), a marketing authorisation for a veterinary medicinal product granted in one EU Member State is recognised in one or more other Member States, unless there are serious concerns. The duration of this procedure is 90 days.
More Information on the mutual recognition procedure can be found here.
Subsequent Recognition Procedure
In the subsequent recognition procedure (SRP), a marketing authorisation for a veterinary medicinal product, which has already undergone a decentralised or mutual recognition procedure is recognised in one or more additional Member States, unless there are serious concerns. The duration of this procedure varies from 30 to 90 days.
Further information
European institutions
Legal basis at European level
Public information according to § 36 TAMG
Marketing authorisation statistics at a glance
Processing statistics for the marketing authorisation of veterinary medicinal products YYYY (German only)
European marketing authorisation procedures
Find out more
- European marketing authorisation procedures
- National authorisation
- Veterinary medicinal products for food-producing animals
- Assessment of applications for marketing authorisation
- Validity of marketing authorisations and re-examination of marketing authorisations for limited markets and in exceptional circumstances
- Marketability and legal status of supply
- Variation of marketing authorisation, registration, exemption
- SPC harmonisation
- Parallel trade
- Registration
- Co-distribution of veterinary medicinal products
- Examination of registration documents