Guidance on applying to renew a marketing authorisation (MA) for a veterinary medicine (formerly in VMGN 2).
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.
This guidance does not apply 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.
You may submit your application electronically, or in hard-copy, see the submission guidance page.
The application form for renewing an MA is available on the European Commission website
You must also provide the following information when submitting an application to renew a nationally authorised product:
- Residual Solvents Declaration
- A list of sites to be retained
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.
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
In January each year you will be sent a list of products due for renewal in the following calendar year, e.g. in January 2016 you will receive a list of products due for renewal in 2017.
However, this reminder is sent as a courtesy and it is your responsibility to submit your renewal application 6 months prior to the renewal date.
No other applications, eg. variations, should be on-going on the product when the renewal is submitted. You must ensure that you time submission of applications so that they do not clash. Refer to the Apply to change a marketing authorisation for an animal medicine page for more information.
Supporting data requirements
When applying to renew a Mutually Recognised product you should provide the information set out in Volume 6c of the European Notice to Applicants.
When applying to renew a Nationally Authorised product you should provide the information listed in the Annex to the application form
SPCs and product literature
See the SPC and Product Literature](https://www.gov.uk/guidance/veterinary-medicines-summary-of-product-characteristics-and-product-literature) page for more details.
For applications dealt with on a national basis the following applies:
- validated within 10 days of receipt
- approved, refused, or questions asked within 60 days of passing validation
- if questions asked, you should provide a full company response within 60 days - this can be extended to 120 days upon request
- approved or refused within 60 days from receipt of a full company response
- following approval, updated authorisation documentation will be issued within 10 days
The timescales for renewals dealt with on a mutual recognition basis are outlined in the relevant Best Practice Guides.
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.
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.
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.
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
As there is no formal application process for reassessing Exceptional MAs, you will be sent an invoice once the VMD has completed its reassessment of the product.
The fee to reassess an Exceptional MA is:
- First reassessment - £305
- Subsequent reassessments - £1,360
The VMD now issues all invoices electronically, so you should provide a valid email address of where to send the invoice; failure to do so will result in your application being rejected.
These are reassessed on an annual basis. This reassessment will examine at 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.
A formal renewal may be required if this is 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.
The valid pass letter will include the contact details of those allocated to deal with your application.
You should include the application number (AN) in all correspondence.
For other enquires email: firstname.lastname@example.org