Validation of applications for veterinary medicines
Source: gov.uk (2025-12-05)

How to make sure an application relating to an authorisation for a veterinary medicine is complete and will pass validation.

This guidance applies to Marketing Authorisations (MAs), Veterinary Homeopathic Registrations (VHRs), Animal Test Certificates (ATCs), Specific Batch Control, and Autogenous Vaccines Authorisations (AVAs).

Most applications made to the Veterinary Medicines Directorate are validated upon receipt.

Those run on a minor or batch timetable aren’t. Details about timetables can be found on the Timetables for national applications (https://www.gov.uk/government/publications/timetables-for-national-applications-for-mas-atcs-and-vhrs) page.

Validation process

You will need to submit specific data and documents to support an application. These will be specified in the relevant guidance documents.

Upon receipt of an application it will be checked to make sure all necessary data and documents have been submitted.

It is your responsibility to identify and submit all necessary supporting data and documents with your application.

If an application is incomplete it may be deferred or failed at validation.

If the application is complete it will pass validation and go into the assessment phase.

Deferred validation

Where only minor information is missing, and can be easily resolved, the application will be deferred.

You will be contacted and asked to submit the missing information within a set timeframe. Once received, the application will restart in the validation period.

Failed validation

Where a major piece of information is missing, or a substantial amount of information is missing, the application will be failed. You will be contacted and asked to resubmit the application in its entirety.

Examples of why an application may fail validation include:
- the wrong documentation has been provided, or information is missing, and it is not possible to supply the documentation needed in a reasonable timeframe
- the proposed reference product for a generic application is not allowed
- the parent product for applications submitted under Informed Consent (Copycat) is undergoing a variation procedure
Passed validation

Complete applications will pass validation. You will be contacted and told that your application is valid and has gone into the assessment phase.

How to submit a valid application

Active Substance Master File (ASMF) in support of an application

If you are intending to use an ASMF in support of your application, you should ensure that the proposed Active Substance Manufacturer (ASM) has supplied the latest version of the full ASMF to the VMD before submitting your application. The ASMF will only be held for 3 months without a supporting application.

A full ASMF includes the open and restricted parts, including Expert reports and Quality Overall Summary if relevant.

New Marketing Authorisations (MAs)

Good Manufacturing Practice (GMP) Certificates

A valid GMP certificate must be provided for all manufacturers listed in the application form. The certificates should not be more than 3 years old from the date of inspection, not the date the certificate was signed.

Some countries issue a combined manufacturing licence and GMP certificate; both documents should be provided for this to be accepted.

If a site has been inspected, but no GMP certificate is available, the VMD will accept written confirmation from the National Competent Authority (NCA) confirming that the site is approved.

Generic and Generic-Hybrid

All sections of the dossier should be addressed.

A full Part II is always required.

The following statement should be used when no data is required for sections of Parts IIIA, B and IV:

As this is a generic application and because of the nature of the product, results of (insert test type (s)) test are not required.

A full User Risk Assessment (URA).

For Generic-Hybrid applications only, a full Part IIIA should be provided.

An Environmental Risk Assessment (ERA)

Informed Consent (Copycats)

An authenticated letter from the parent MA holder (party granting consent) to use their data is required and must state the name of the informed consent applicant and the product concerned.

This is not necessary if the parent MA holder is the same as the proposed copycat MA holder.

Full Part IA or B

Fully completed application form including all appropriate annexes, where applicable. If the information is not available to the proposed holder of the copycat, cross references to the parent product are acceptable.

Proposed copy of the Finished Product Specification (FPS), which should cite the name of the proposed product, submitted on company headed paper, signed and dated.

You do not need to submit a full Part II, III or IV, but the informed consent applicant must have permanent access to this information.

SRP - Subsequent Recognition Procedure

You should submit the original dossier plus updates to the dossier as appendices. Updates include questions and responses from the original procedure, subsequent procedures, for example variations and post authorisation commitments.

These updates can be included in the Additional Information folder of your submission.

Variation applications for MAs and Homeopathic Registrations

VNRA – Variations Not Requiring Assessment do not have a validation period and will progress straight to assessment.

VRA – Variations Requiring Assessment and Homeopathic Registrations will have specific documentation requirements depending on the application type applied for. These will be checked during the validation period.

Further information on variations is available at Apply to change a veterinary Marketing Authorisation or Homeopathic Remedy - GOV.UK (https://www.gov.uk/guidance/apply-to-change-a-marketing-authorisation-for-an-animal-medicine#how-to-submit-your-application)

Contact

For validation enquiries email: xxx@xxx.xx (mailto:xxx@xxx.xx) and quote ‘validation’ in the subject line.