Glossary
AMMmarketing authorisation
The AMM is the marketing authorisation a veterinary medicine needs before it can be sold, granted in France by the ANMV or at EU level by the European Commission.
Since 28 January 2022, a veterinary marketing authorisation is valid for an unlimited period (article 5 of Regulation (EU) 2019/6). It sets the medicine’s SPC and its prescription status.
Sources
See also
- RCP The RCP, or SPC (summary of product characteristics), is the official document attached to a veterinary marketing authorisation that sets out the medicine’s composition, target species, indications, dosage, contraindications and withdrawal periods (article 35 of Regulation (EU) 2019/6).
- Cascade The cascade is the derogation that lets a vet, exceptionally and on their own responsibility, prescribe a medicine outside its marketing authorisation when no authorised product exists for the species and condition (articles 112 to 114 of Regulation (EU) 2019/6).
- ANMV The ANMV is the department of ANSES, based in Fougères, that acts as France’s competent authority for veterinary medicines.