Extension to submission slots requirement to include specific MAs

From: Veterinary Medicines Directorate

In order for the VMD to prioritise its resources and expertise and provide you with a predictable authorisation process; we will be extending the requirement for submission slots to include national marketing authorisations for selected pharmaceutical applications submitted under Article 12(3) (full) or 13a (well-established use/bibliographic). 

Applicants should contact us at least six months in advance to discuss your application(s). We may suggest a virtual company meeting for you to outline your proposed application and to discuss the regulatory aspects and timing of the submission.

Please contact submissionslot@vmd.gov.uk to request a submission slot and include the following minimum information:

• Your proposed legal base (Article 12(3) or 13a)
• Active substance
• Pharmaceutical form
• Species
• Brief summary of indication sought
• Regulatory submission strategy for GB and/or NI
• Proposed submission date

All other pharmaceutical application types, including parallel submissions, do not require a submission slot.