Your guide to PAGB's pre-vetting pack design service (expedited MHRA approval)

PAGB offers pre-vetting of the changes to pack design and layout for over-the-counter medicines, as part of MHRA’s expedited P3 assessment procedure.

More information on the P3 submission category can be found in the MHRA guidance on Submitting changes to Labelling and Patient information leaflets.

(Please note the requirements below)

What’s the benefit?

A valid application that has been through the PAGB pre-vetting service will be assessed by the MHRA within 30 days rather than the usual 90-day period for direct submissions.

When can I use the PAGB pre-vetting service?

You can submit your pack design for existing products for review, where there are changes to any or all of layout of the information, changes to the content of the information and changes to graphics on the pack, which do not result from changes to the SmPC (that is, those changes which fall under the P3 category of the MHRA submission guidance).

Please note, packaging for new product submission or changes which require a variation are not covered by the PAGB pre-vetting service.

What does PAGB review?

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

This service specifically covers:

• Non-statutory changes to pack design and layout for an existing product
  • Changes to any or all of the layout of the information
  • Changes to the content of the information
  • Changes to the graphics on the pack design
• Other pack components which are part of the submission to the MHRA, such as a blister foil, sachet or label, can also be reviewed and stamped.

What do we not cover?

• Pack designs for first approval of mock-ups following a granting of an MA
• Changes which result from updates to the SmPC and changes to the PIL
• Medical device and food supplement product packs are not covered under the P3 expedited review. However, they can be assessed, and advice provided via the regulatory@pagb.co.uk or foodsupplements@pagb.co.uk inboxes

How long will it take to review my pack?

We aim to complete assessment of your pack within 5 days of receipt of a valid application. Please see below for how to submit your pack and what information you need to send.

How do I submit my pack design for review?

Please email the following items to packdesign@pagb.co.uk

1. A verification that the submission is for P3 expedited review
2. A copy of the currently approved pack design (all sides of pack to be included)
3. A mock-up of the proposed pack design (all sides of pack to be included)
4. A description of the updates made
5. Please note that in your submission to MHRA, a highlighted change document needs to be included. It would be beneficial to include this in your pack design submission to PAGB as well.
6. Non-members should also include a purchase order number and billing address for invoicing.

Please note: if your attachments are greater than 25 MB it will not reach us. We recommend you use something like WeTransfer for attachments larger than 25 MB.

How much does this service cost?