The worksharing procedure enables marketing authorisation holders for veterinary medicines to combine the same variations affecting different medicines into a single application, irrespective of the authorisation route of the medicines. Guidance is available from the European Medicines Agency (EMA) on this procedure in the form of questions and...

Guidance is available from the European Medicines Agency (EMA) on variations for centrally authorised veterinary medicines requiring assessment under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6). This includes information on the documents that marketing authorisation holders will need to submit as part of the variation...

The European Medicines Agency (EMA) is responsible for the scientific evaluation of centralised marketing authorisation applications (MAA). Once granted by the European Commission, the centralised marketing authorisation is valid in all European Union (EU) Member States, Iceland, Norway and Liechtenstein.

Good manufacturing practice (GMP) describes the minimum standard that a medicines manufacturer must meet in their production processes. The European Medicines Agency (EMA) coordinates inspections to verify compliance with these standards and plays a key role in harmonising GMP activities at European Union (EU) level.