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.

Further information about marketing authorisations (MAs) can be found on the Marketing authorisations for veterinary medicines page.

How to apply

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

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)

If you submit a number of applications for a product range, such as different strengths and pharmaceutical forms of a product, these will be grouped together for assessment purposes and one application number assigned.

An example of a product range is as follows:

  • VMD 10 mg tablet for cats and small dogs
  • VMD 20 mg tablet for medium size dogs
  • VMD 30 mg tablets for large dogs

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 based on reduced data packages.

The data requirements for Exceptional MAs are annexed to the application form. 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.

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

Further information about application timescales can be found on the Timetables for national applications page.

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 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

  • To request a company meeting email: postmaster@vmd.defra.gsi.gov.uk and include ‘request for a company meeting’ in the subject line
  • To discuss specific application points, contact the persons assigned to the application as notified in the validation passed email
  • For all other enquiries email: postmaster@vmd.defra.gsi.gov.uk
Published 27 November 2014
Last updated 1 April 2019 + show all updates
  1. Minor changes and addition of link to new timetables for national applications page
  2. Guidance reviewed and updated. Reference to MAPIs removed, see seperate guidance
  3. Updated MAPI application form
  4. Revised link to SPC and product literature guidance
  5. Inclusion of expiry procedure guidance
  6. New combined QRD template for national applications
  7. First published.