Guidance

Apply for a Marketing Authorisation for a veterinary medicine or expiry

Guidance and application form to apply for a Marketing Authorisation (MA) to place a veterinary medicine on the market, or to expire an MA.

Details on the following can be found on the Marketing authorisations for veterinary medicines page.

  • Authorisation Routes
  • Legal Bases
  • Post-Authorisations Steps
  • Distribution Categories

How to apply

For additional information about the Mutual Recognition and Decentralised procedures, go to the Heads of Medicines Agencies website.

For guidance and information about the centralised procedures, go to the Commission Website.

Prior to submission

You are welcome to meet with VMD assessors to discuss your proposed application; we strongly encourage you to do this particularly in the case of Exceptional MAs. To arrange a meeting, please email: postmaster@vmd.defra.gsi.gov.uk and include ‘Request to arrange a company meeting’ in the subject line.

Submission

You may submit your application electronically, or in hard-copy. See the Submission of an application for an animal medicine licence page for more details.

Application Form

Application forms are available on the European Commission Website except the following:

Guidance for the covering letter (PDF, 21.4KB, 3 pages)

Data Requirements

You should provide the information set out in Volumes 6a and 6b of the European Notice to Applicants and in Annex 1 of Directive 2001 / 82 / EC, as amended.

The VMD will take in to account any other data or knowledge that it has when assessing applications for abridged MAs.

The data requirements for Exceptional MAs and MAPIs are annexed to their application forms. For Exceptional MAs, you should explain in a covering letter accompanying your application how your product will fill a therapeutic gap in the market.

Validation

All applications are checked (validated) upon receipt.

It is up to you to identify and submit all the necessary information in support of your application. If the application is incomplete, it is likely to fail validation.

Assessment

Once the application has passed validation, it will proceed into the assessment phase.

The timescales may be suspended if we need further information from you, or in accordance with the timetables set for applications dealt with on a European level.

If the outcome is to approve an application, you will be sent authorisation documentation at the end of the application procedure.

SPCs and product literature

See the SPC and Product Literature guidance page for more details.

Timescales

The following provides information on the timescales used for applications dealt with on a national basis. The timescales for variations dealt with on a mutual recognition basis are outlined in the relevant Best Practice Guides.

Validation Validated within 10 days of receipt. NB. 21 days for Limited MAs
Initial Assessment Approved, refused, or questions asked within 90* days of validation passed
Company Response If questions asked, you should provide a full company response within the deadline set
Sign-off Approved or refused by 180** days from receipt. The timescales may be suspended during this time if further information is required from you
Mock-ups Mock-ups approved within 20 days from receipt of correct versions
Issue Following approval, authorisation documentation will be issued within 10 days

*75 days for copycats and MAPIs (where the parent product is mutually recognised)

**130 days for copycats and MAPIs (where the parent product is mutually recognised)

Fees

Once an application has passed validation, you will be sent an invoice for the fee

For further information about fees see the Application fees for animal medicines page.

You can use the fees calculator to help you work out what the fee will be.

The VMD now issues all invoices electronically, so please provide a valid email address of where to send the invoice; failure to do so will result in your application being rejected.

Expiry of a Marketing Authorisation

To expire a Marketing Authorisation, Animal Test Certificate, or Homeopathic Registration, you will need to send an email to: s.response@vmd.defra.gsi.gov.uk.

Expiry of an MA or Homeopathic Registration means that no more product may be released by the qualified person (QP) on or after the date of expiry. Any product already QP released may still be placed on the market for sale and supply after this date unless the MA or Registration has been expired due to safety reasons. In this case, this will be noted in the expiry letter sent to you.

Contact us

For queries relating to on-going applications, please contact the relevant person stated on the email sent to you following validation of your application.

For other enquiries email: postmaster@vmd.defra.gsi.gov.uk

Published 27 November 2014
Last updated 7 December 2017 + show all updates
  1. Updated MAPI application form
  2. Revised link to SPC and product literature guidance
  3. Inclusion of expiry procedure guidance
  4. New combined QRD template for national applications
  5. First published.