All medicines must be authorised before they can be marketed and made available to patient. Routes of Authorisation: Community authorisations National authorisations
Applicant shoud submit medical and immunological expert statements about prodcut quality, safety, efficacy referenced citation attached. Documented manufacturind process and quality controll.
Document set should be submitted in VNEES form in electronic ways to national authorities.
- DIRECTIVE 2001/82/EC on the Community code relating to veterinary medicinal products
- EUDRALEX vol 6a Ch 1. on Marketing Authorisations
- EUDRALEX vol 6b on Presentation and content of the dossier
The Marketing Authorisation Holder should provide the full information on suspected adverse event observed in an animal or human following the use of a veterinary medicinal product immediately and in no case later than 15 calendar days, for any suspected serious adverse reactions and human reactions, to the National Competent Aithority on whose territory the adverse event occurred.
The marketing authorisation holder (MAH) is expected to provide Periodic Safety Update Report (PSUR) a critical scientific evaluation of the benefit-risk balance of the veterinary medicinal product in the light of new or changing post-authorisation safety information.