How and when to register updated packaging and information leaflets when new national marketing authorisations have been issued
Once you have been issued with your new Marketing Authorisation (MA) to convert a previously EU-wide to an MA for Great Britain, you will have no later than 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 and/or the 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 and/or the 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. Normal fee arrangements apply.
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. Normal fee arrangements apply.
If you are making any other changes to the statutory information or the pack design (which are not consequential to a change to the Summary of Product Characteristics (SmPC)), you will need to submit the artwork for full assessment to the Product Information Quality Unit under change code P2. Normal fee arrangements apply.
Packs containing the Falsified Medicines Directive (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/or in the PIL, provided that the entirety of the information is compliant with the UK requirements.
Submission and best practice
Full details on how to submit applications for assessment, national best practice guidance and the fees.
For further information, please email our Customer Services Centre at firstname.lastname@example.org or call 020 3080 6000. Alternatively, contact your Trade Association by emailing:
- Association of the British Pharmaceutical Industry (ABPI): email@example.com
- British Generic Manufacturers Association (BGMA): firstname.lastname@example.org
- BioIndustry Association (BIA): email@example.com
- Clinical & Contract Research Association (CCRA): firstname.lastname@example.org
- Ethical Medicines Industry Group (EMIG): email@example.com
- Health Food Manufacturers’ Association (HFMA): firstname.lastname@example.org
- The National Pharmacy Association (NPA): email@example.com
- Proprietary Association of Great Britain (PAGB): firstname.lastname@example.org