Submission advice for a veterinary marketing authorisation

How to submit an application, data package and responses for proposed or existing marketing authorisations.

This applies to marketing authorisations, veterinary homeopathic registrations, animal test certificates, specific batch control, autogenous vaccines, non-food animal blood banks and equine stem cell centres.

Applications and responses must be submitted electronically.

Submission slots for new National Marketing Authorisation applications

Applicants should obtain a submission slot in advance of submitting the following National MA application types:

A submission slot should be requested at least 6 months prior to your planned submission date. 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 [email protected] to request a submission slot and include the following minimum information:

All other application types do not require a submission slot.

As a requirement of the approval of the Marketing Authorisation, you may need to provide conditional data to the VMD by the stated deadline.

Use the VMDS ‘Other’ submission route to submit conditional data.

The Veterinary Medicines Digital Service (VMDS) is the UK submission and communication system. You must use this to apply for new national authorisations, to vary existing ones and to submit information in support of other licensing activities, such as mock-ups and animal test certificates.

National applications and responses to questions that we ask you during the application must be submitted through the VMDS.