Registering new packaging information for medicines
Once you have been issued with your new Marketing Authorisation (MA) to convert a previously EU-wide MA to a MA for Great Britain, you will have 24 months (starting 1 January 2021) to establish and register a Great Britain presence for your MA.
This will include submitting amended artwork for approval to accommodate the following new administrative information:
- name and address of Marketing Authorisation Holder (MAH) or representative
- Great Britain MA number
- name and address of product manufacturer for batch release
Actions to take once you have been issued an MA
You will have a further 12 months (36 months in total from 1 January 2021) to ensure all stock released to market is in compliant packaging. This additional time allows for assessment of your submission(s) and time for implementation in the production schedule.
You may need to amend the labelling/ Patient Information Leaflet (PIL) to take account of new information as a result of a variation application submitted between the grant of the new MA and 24 months from 1 January 2021. In such cases, the changed artwork which accompanies that variation application should include the new administrative information at that earlier time.
If you are making changes to the labelling/ PIL as a consequence of a variation application, you should submit the full colour mock-ups as part of the variation submission. These will be assessed and approved as part of the variation procedure.
If you are only changing the name and address of the marketing authorisation and/or the manufacturer for batch release (stated in the PIL) you may do this as part of a Better Regulation of Medicines Initiative (BROMI) notification.
For any other changes to the statutory information or the pack design (which are not consequential to a change to the SPC) you will need to submit the artwork for full assessment to the PIQ Unit under change code P2.
Packs containing the FMD safety features would still be accepted in the UK, provided that they are in line with other UK packaging requirements.
The MHRA will continue to allow multi-country packs, including packs with more than one language on the pack and/ PIL, provided that the entirety of the information is compliant with the UK requirements.
To receive your Complimentary BREXIT LICENCE REVIEW:
Contact us at firstname.lastname@example.org or submit the form on our Brexit page.
If you would like to discuss how Fusion Pharma can support you with packaging, please email us at email@example.com or phone us on +44 (0) 203 1379 799.