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 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.documents available via the quick link provided on the landing page.

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.deferred, for example, the problem can be resolved with the re-submission of data within a short time period.

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
• an invalid GMP certificate has been provided, or one that is not authorised for veterinary medicines
• the manufacturer’s licence does not list the correct approved processes or the pharmaceutical form including that of the product
• 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 or renewal 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. You will also be told the names of the staff dealing with your application and their contact details.

How to submit a valid application

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

If you are intending to use anthe European ASMF procedure in support of your application, you should ensure that the proposed Active Substance Manufacturer (ASM) has suppliedlodged the latest version of the full ASMF towith 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 reportsreports, andor Quality Overall SummarySummary, if relevant.submitted in CTD format.

This applies whether:

• the active substance is new to UK veterinary medicinal products
• the active substance is from an ASM previously not seen in the UK
• an updated file from the ASM has previously been seen by the VMD

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 countriesMember States 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.

Table of materials of human and animal origin

Either the European tables of materials of human and animal origin or the old style TSE declaration and format tables should be provided with all applications for new MAs.

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 submitted according to Article 13 (1) of Directive 2001/82/EC, as amended, and bioequivalence with the reference product can be assumed, 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)

Demonstration of informed consent must be fulfilled. An authenticated letter from the parentparty MA holder (party granting consent)consent to(holder useof theirthe dataparent MA) is required and must state the name of the informedbenefitting consentparty 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.possible. 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 informedproposed consentholder applicantof the copycat must have permanent access to this information.

SRPMRP -– SubsequentRepeat Recognition ProcedureUse

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

TheseFor e-submissions, these updates can be included in the Additional Information folder of yourthe submission.TIGes structure.

Fee increments for novel active substances

An additional fee will be charged for each active substance that has not previously been included in a veterinary medicine authorised in the UK.

Variation applications for MAs and Homeopathic Registrations

VNRA

Type –IA Variations (Variation Not Requiring Assessment do(VNRA))

These applications are not havevalidated; athey validationare periodaccepted or rejected and willa progressfee straightis topayable assessment.whatever the outcome.

VRAAnnual –updates should not be submitted if one or more of the products involved are undergoing another procedure, for example, another variation, renewal, MRP, etc.

Type IA (VNRA) annual notification changes can be submitted with other unrelated Type IB (VRA) or II changes (VRA).

Type IA (VNRA) immediate notification changes can only be submitted with other Type IB (VRA) or II (VRA) changes that fall within the grouping as per Annex III of the variation regulations.

Type II Variations (Variation Requiring Assessment and(VRA)) Homeopathic– RegistrationsExpert willReport

A havedetailed specificand documentationcritical requirementssummary dependingtogether onwith a CV of the applicationexpert typewho appliedprepared for.the Thesesummary willshould be checkedprovided duringfor every Type II (VRA) variation, except where it has been previously agreed with the validationVMD period.that you do not need to supply this information.

Further

Present informationand proposed box on the application form

This box should be completed for all variations

Simultaneous issubmission availableof atapplications

Companies Applyshould time submission of their applications to changeensure that a veterinaryproduct Marketingis Authorisationonly orsubject Homeopathicof Remedyone -application GOV.UKat any one time.

Variations should not be submitted if the product is undergoing another variation, renewal, MRP, etc.

Contact

For validation enquiries email: s.response@vmd.gov.uk and quote ‘validation’ in the subject line.