Requirement for submission slots extended
Submission opportunities available to applicants of veterinary product marketing authorisations.
The requirement for submission slots to be obtained for new and extension variation applications for biological and bio-pharm products, as described in our announcement on 7 May 2021, has been extended indefinitely.
There is currently no requirement for submission slots for Pharmaceutical applications. However, applicants are now required to provide the VMD with a minimum 6-month forewarning of any new MA Pharmaceutical applications intended to be submitted under Article 12(3) (full) or 13a (well-established use/bibliographic).
Full details can be found in the guidance for Submission of an application for an animal medicine authorisation.
Please contact us at [email protected] to arrange a meeting.