Applications and responses must be submitted electronically and the presentation and format of the dossier must be in accordance with VNeeS guidelines.
You must prove technical validity before submission of the electronic dossier and should include the validation report in the add-info folder of the VNeeS submission.
Apply for veterinary medicine authorisations
Guidance for the pharmaceutical industry on how to apply for an authorisation to place a veterinary medicine on the UK market or part of, or to expire one ..
Before submitting your application
Before you apply for a Marketing Authorisation (MA), we recommend that you discuss your proposed application with us, particularly for an exceptional MA or if you wish to submit a GB application in parallel with a new EU procedure. Send us an email at vmds@uk.gov.
You must be registered to use (VMD) Veterinary Medicines Digital Service.
Dossier Documents
The Dossier format allowed is VNees and Nees. The dossier files are uploaded in chunked sections, starting with the root folder which contains the general table of contents, then followed by four main parts:
1. Part 1. Summary of the dossier
2. Part 2: Quality Documentation
3. Part 3: Safety Documentation
4: Efficacy Documentation
For More information, check here esubmission for VNeeS different versions
Application Form
Application forms to apply for a national Marketing Authorisation, or to vary or renew existing ones, are online through the VMDS
Application Fees
Fees are charged for specific activities carried out by the Veterinary Medicines Directorate.
The fees payable will be confirmed upon successful validation of the application. Once an application has passed validation, you will be sent an invoice for the fee by email so you must provide a valid email address in your application.
Paying The Invoice
Payment should not accompany an application, or be paid in advance of an activity.
You will be sent an invoice for the fee following receipt of your application, or whilst the activity is underway.
The invoice will be sent via email, so it is important that you provide a valid email address with your application or request
Payments to the VMD can be made either by Cheque or BACS, quoting the Customer Code and Invoice number quoted on the invoice.
If you have any related queries about the invoice, email to finance@vmd.gov.
Non-refundable fees.
The application and annual fees are not refundable or transferable.
