Guidance

Apply to renew a marketing authorisation for a veterinary medicine

Guidance on applying to renew a marketing authorisation (MA) for a veterinary medicine.

A marketing authorisation (MA) must be renewed five years following initial authorisation to remain valid.

If an MA is not renewed it will cease to be valid and the product may no longer be released onto the market for sale and supply.

To renew an MA you need to submit an application to the VMD.

Different criterion applies to Exceptional MAs.

How to apply

For additional information about renewing a mutually recognised or nationally authorised MA go to the HMA website

For guidance and information about renewing a centrally authorised MA, go to the European Commission Website.

Submission

See the Submission of an application for an animal medicine licence page for more details.

Changes to MAs

A renewal application will not be accepted if there are other applications being processed on the product, eg. variations.

You must time submission of your applications so that they do not coincide.

Application form

The application form for renewing an MA is available on the European Commission website.

An application can include all strengths and pharmaceutical forms of a product, ie. the so-called ‘product range’.

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

You will be charged per product, not application.

Validation

All applications are checked (validated) upon receipt.

You must 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.

If any changes are identified during the renewal procedure, the renewal may be granted subject to a condition(s), ie. the applicant may be asked to submit a variation(s) once the renewal is completed to make the change(s) to the MA.

Data requirements

You must include a consolidated list of documents in respect of quality, safety and efficacy including all variations introduced since the MA was granted.

The consolidated list of documents is detailed in the application form.

For national renewals, you must also provide the following information:

  • Residual Solvents Declaration
  • A list of sites to eb retained

SPCs and product literature

See the SPC and Product Literature page for more details.

Timescales

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

UKPAR

The UK public assessment report will be updated following a renewal to reflect any changes made.

The post authorisation assessment (PAA) document will be updated following successful completion of a renewal for nationally authorised and mutually recognised products.

Exceptional MAs

These are reassessed on an annual basis without the need for you to submit an application or any supporting data.

This reassessment will examine all relevant data available to the VMD to confirm that the benefit:risk balance remains favourable; if not, the MA may be suspended or expired.

There is no fee to reassess an Exceptional MA.

If a formal renewal is required, this will be specified as a condition on the initial authorisation. The timing of the renewal and the supporting data to be supplied will also be specified. In these cases, the full renewal fee will apply.

Fees

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

The fee to renew a nationally authorised MA is £1,360.

The fee to renew a mutually recognised MA is:

  • UK as RMS - £1,835
  • UK as CMS - £1,225

Note – the fee applies to each MA included in an application.

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

Contact us

  • To request a company meeting email: postmaster@vmd.gov.uk
  • To discuss specific application points you should contact the persons assigned to the application as notified in the validation passed email
  • For all other enquiries email: postmaster@vmd.gov.uk
Published 2 June 2015
Last updated 1 April 2019 + show all updates
  1. Minor changes and addition of link to new timetables for national applications page

  2. Revised link to SPC and product literature guidance

  3. First published.