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Changes to the way you submit mock-up veterinary medicine product literature

New process and email address for submission of mock-up product literature changes made via a notification procedure.

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Any change to mock-up product literature that does not affect approved text or legibility (e.g. font size, layout) may be introduced via a notification to the Veterinary Medicines Directorate.

If you wish for changes to be considered as a notification, submit an email request to and include the following information:

  • Detail of all proposed change(s) in comparison to the current authorised mock-up(s)
  • Confirm that all other text remains unchanged (to include wording and font size)

If you choose to provide mock-ups these will be used to help define the proposed changes but will not be assessed.

If the proposed change cannot be made by way of a notification, a variation will need to be submitted in the usual way.

For UK/Irish joint-labelled products, you will also need to consult directly with the Health Products Regulatory Authority, Ireland.

There is no fee for a notification.

For further information email

Further information and current guidance about product literature see the Veterinary Medicines: Summary of Product Characteristics and Product Literature.

Published 8 July 2016