Transparency (veterinary medicines)

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:

• Veterinary EPARs
• What we publish on medicines and when
• Annual reports and work programmes

Principles for publication of agendas and minutes of EMA scientific committees

Reference Number: EMA/555647/2013