Compliance: marketing authorisation
Marketing authorisation holders are responsible for ensuring that they and any parties working for them comply with all relevant standards set out in European Union (EU) legislation and guidelines. Compliance with these standards ensures the reliability and integrity of the data that support the authorisation of veterinary medicines and their quality, safety and effectiveness once on the market.
The European Medicines Agency (EMA) is responsible for harmonising these standards at EU level. It also coordinates inspections to verify that veterinary medicine developers comply with them.
The Agency's scientific committees may request that samples of medicines are analysed in an official laboratory as part of the approval process.
In this section
The regulatory information on compliance for veterinary medicines is contained together with the information on human medicines.
- Pharmacovigilance inspections
- Pharmacovigilance inspection procedures: veterinary
- Sampling and testing
In other sections
Marketing authorisation holders should also consider the regulatory information in the sections below: