Glossary
RCPsummary of product characteristics (SPC)
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).
In France, SPCs are published in the index of authorised veterinary medicines kept by the ANMV. Using a medicine outside its SPC falls under the cascade.
Sources
See also
- AMM 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.
- 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.