Once a veterinary product has received approval from the Commission (the “Commission Decision”) all further procedures connected with the product will fall under “Post-Authorisation Procedures”.
This guidance provides an overview for a number of procedures that occur frequently and addresses a number of questions which Marketing Authorisation Holders (MAHs) may have.
- More information on this post-authorisation procedural advice Q&A.
- The Rules governing Medicinal Products in the European Union, Volume 6, Notice to Applicants
- Community Legislation
- Mock-ups checklist - Guidance for checking mock-ups
- The revised checking process of mock-ups and specimens of outer/immediate labelling and package leaflets in the centralised procedure for veterinary medicinal products