Transparency (veterinary medicines)
VeterinaryRegulatory and procedural guidance
The European Medicines Agency (EMA) publishes information on veterinary medicines at various stages of their lifecycles, including on post-authorisation changes.
EMA publishes redacted agendas and minutes of the Committee for Medicinal Products for Veterinary Use (CVMP) since 2013.
The published agendas and minutes include information on the post-authorisation procedures discussed by the committee, whether or not the procedure is finalised. This covers:
- extensions of marketing authorisation (such as a new pharmaceutical form, a new route of administration, a new strength, a new presentation),
- type II variations including extensions of indication, worksharing variations, post-authorisation measures, PSURs and renewals;
- the assessment reports for extensions and major Type II variations, after redaction to remove information of a commercially confidential nature.
The following information is also made publicly available:
- CVMP press releases which are published on a monthly basis after each CVMP meeting;
- CVMP monthly reports which are published on a monthly basis after each CVMP meeting;
- CVMP summaries of opinions which are product-specific and published shortly after adoption of the relevant CVMP opinion;
- EPARs, which are product-specific and updated upon completion of post-authorisation procedures;
- EMA annual reports and work programmes.
More information: