The MHRA have reviewed how the BROMI Notification scheme has been working since it was expanded in July 2012 to include changes to labelling and patient information leaflets.
Of the 452 notifications received, only four should have been submitted for full assessment by the MHRA Patient Information Quality Unit. All four cases involved significant changes to the design and layout of the leaflet and should have been submitted under change code P2 with supporting data.
The MHRA offered the following advice to MA holders:
- Remember to include consolidated artwork with your submission
- Use the correct Notification form (the form to use is different depending whether you use the MHRA portal or are submitting on disk)
- Notifications do not need a change code, but a brief description of the changes should be included on the form and covering letter
- For changes submitted for full assessment, the relevant category(ies) and description of the changes should be detailed in the application
Regulis can help you submit your artwork changes. For further advice or guidance, please contact us via our Contacts page or by emailing email@example.com