Apply to renew a marketing authorisation for a veterinary medicine
Guidance on applying to renew a marketing authorisation (MA) for a veterinary medicine.
A marketing authorisation (MA) must be renewed five years following initial authorisation to remain valid.
If an MA is not renewed it will cease to be valid and the product may no longer be released onto the market for sale and supply.
To renew an MA you need to submit an application to the VMD.
Different criterion applies to Exceptional MAs.
Before submitting your application
You must be registered to use the Veterinary Medicines Digital Service (VMDS).
From the 28 January 2022, the EU will no longer require the renewal of Marketing Authorisations. Therefore, from the 1 January 2022, all MA renewal applications will be run administratively with reduced data requirements, to ease the burden on industry.
No other applications can be running during the renewal procedure.
NI National and DCP/MRP MAs
NI MAs issued by VMD previous to 28 January 2022, will have a 5 year validity period. In order to get this extended indefinitely, you will need to submit national administrative renewal application(s), within 6-9 months of your renewal due date:
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Aligned GB and NI MAs – you should submit one national (GB & NI) application form.
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Non-aligned GB and NI MAs – you should submit independent national application forms.
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De-aligned GB and NI MAs – you should submit two national application forms in parallel, the fee for the parallel NI application is discounted to £273.
Extending the validity of NI – Centrally Authorised Procedure MAs is controlled by the EMA. No national action is required.
Submission
See the Submission of an application for an animal medicine licence page for more details.
Application form
The application form to apply for a GB national renewal is now available online through the VMDS.
Validation
All applications are checked (validated) upon receipt to check that everything has been provided in order to progress
If the submission is incomplete, we may not be able to progress your application.
We will contact you if further information is needed.
Fees
Once an application has passed validation, you will be sent an invoice for the fee so you must provide a valid email address in your application.
See: Fees applied to animal medicine authorisation applications
Assessment
Once the application has passed validation, it will proceed on an administrative timetable. See Timetables for national applications.
Data requirements
For GB national renewals, you must provide the following documents along with your application:
- Chronological list of all post authorisation submissions, such as variations and extensions, and conditions since grant of marketing authorisation or last renewal indicating scope, status, date of submission and date when issue had been resolved
- List of any outstanding conditions on the Marketing Authorisation
- A statement, or when available, a certificate of GMP compliance or equivalent, not more than three years old, for the manufacturer(s) of the medicinal product listed in the application issued by a competent authority or MRA partner authority. The country of issue should also be included
Applications and responses must be submitted electronically and the presentation and format of the dossier must be in accordance with VNeeS guidelines.
Exceptional MAs
These are reassessed on an annual basis without the need for you to submit an application or any supporting data.
This reassessment will examine all relevant data available to the VMD to confirm that the benefit:risk balance remains favourable; if not, the MA may be suspended or expired.
There is no fee to reassess an Exceptional MA.
If a formal renewal is required, this will be specified as a condition on the initial authorisation. The timing of the renewal and the supporting data to be supplied will also be specified. In these cases, the full renewal fee will apply.
Contact us
- To request a company meeting email: postmaster@vmd.gov.uk and include ‘Request a company meeting’ in the subject line
- To discuss specific application points you should contact the persons assigned to the application as notified in the validation passed email
- For all other enquiries email: postmaster@vmd.gov.uk
Updates to this page
Last updated 27 June 2022 + show all updates
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Updated application requirements for NI National and DCP/MRP MAs to get validity extended indefinitely,
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Changes to the GB renewal timetable and reduced data requirements from the 1st January 2022
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New sectioned added for 'Parallel submissions' and updated sections for 'Assessment' and UK Public Assessment Reports.
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Minor changes and addition of link to new timetables for national applications page
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Revised link to SPC and product literature guidance
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First published.