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, Homeopathic Registrations, Animal Test Certificates, Specific Batch Control, Autogenous Vaccines, Non-Food Animal Blood Banks, and Equine Stem Cell Centres.
All applications made to the Veterinary Medicines Directorate, except Type IA variations are validated upon receipt.
You will need to submit specific data and documents to support an application. These will be specified in the relevant guidance 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 go into the assessment phase.
Where only minor information is missing, and can be easily resolved, the application will be deferred, eg. 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.
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
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 the European ASMF procedure in support of your application, you should ensure that the proposed Active Substance Manufacturer (ASM) has lodged the latest version of the full ASMF with 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, or Quality Overall Summary, if 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 Member 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 party granting consent (holder of the parent MA) is required and must state the name of the benefitting party and the product concerned.
This is not necessary if the parent holder is the same as the proposed copycat holder.
Full Part IA or B
Fully completed application form including all appropriate annexes, where 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 proposed holder of the copycat must have permanent access to this information.
MRP – Repeat Use
You should submit the original dossier plus updates to the dossier as appendices. Updates include questions and responses from the original procedure, subsequent variations, renewals, post authorisation commitments, etc.
For e-submissions, these updates can be included in the Additional Information folder of the 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
Type IA Variations
These applications are not validated; they are accepted or rejected and a fee is payable whatever the outcome.
Annual updates should not be submitted if one or more of the products involved are undergoing another procedure, eg. another variation, renewal, MRP, etc.
Type IA annual notification changes can be submitted with other unrelated Type IB or II changes.
Type IA immediate notification changes can only be submitted with other Type IB or II changes that fall within the grouping as per Annex III of the variation regulations.
Type II Variations – Expert Report
A detailed and critical summary together with a CV of the expert who prepared the summary should be provided for every Type II variation, except where it has been previously agreed with the VMD that you do not need to supply this information.
Present and proposed box on the application form
This box should be completed for all variations
Simultaneous submission of applications
Companies should time submission of their applications to ensure that a product is only subject of one application at any one time.
Variations should not be submitted if the product is undergoing another variation, renewal, MRP, etc.
For validation enquiries email: email@example.com and quote ‘validation’ in the subject line.
Published: 25 August 2015