PAGB pack design services

PAGB’s pre-approval scheme only applies to the updated pack design and non-statutory information, though the statutory information will also be assessed during pre-vetting to provide feedback on compliance with the current regulatory requirements.

You can submit pack design changes of existing products for review, where there are changes to the:

• layout of the information
• content of the information
• graphics on pack
• other pack components such as blister foil, sachet, or label

Some minor designs changes to the patient information leaflet (PIL) may also be included in your submission. Minor changes include changes to the brand logo that appears at the top of the PIL. Other changes to the PIL should continue to be submitted for assessment or as a self-certification submission via the Product Information Quality Unit (PIQU) at MHRA.

Self-certified changes made alongside P3 changes can be grouped under a P3Ex submission.

PAGB has compiled a positive list of acceptable changes to demonstrate the circumstances under which changes to the labelling and PIL can be subject to self-certification. This list can be found in the PAGB notification scheme guidance.

Pack designs for first approval of mock-ups following a granting of a marketing authorisation, changes which result from updates to the summary of product characteristics (SmPC), and changes which require a variation are not covered by the PAGB pre-approval scheme.

Medical device and food supplement products are not covered under the PAGB pre-approval scheme, however, we can provide advice.

Email the following items to packdesign@pagb.co.uk, stating clearly that the submission is for P3Ex review:

• Copy of the currently approved artwork and / or PIL
• Mock up of the proposed artwork and / or PIL
• Copy of the currently approved SmPC
• Description of the changes made or a highlighted change document
• PO number or billing address (for products not in PAGB membership)

All companies using PAGB’s pre-approval scheme are required to notify PAGB of the outcome of their application to the MHRA.