Veterinary Medicines Directorate
October 13
11:03
2022
The requirement for submission slots to be obtained for new and extension variation applications for biological and bio-pharm products, as described inour 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 forSubmission of an application for an animal medicine authorisation.
Please contact us atsubmissionslot@vmd