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 email@example.com 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 firstname.lastname@example.org.
Further information and current guidance about product literature see the Veterinary Medicines: Summary of Product Characteristics and Product Literature.