Requirement for submission slots extended

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 submissionslot@vmd.gov.uk to arrange a meeting.