PAGB offers pre-vetting of the changes to pack design and layout for over-the-counter medicines, as part of MHRA’s P3 expedited (P3Ex) 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)
PAGB’s Packaging Code for Medicines sets out the requirements for packaging and labelling for OTC medicines.
About PAGB’s pre-vetting pack design service
Why should I use PAGB’s medicines pack design service?
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.
Can I use PAGB’s medicines pack design service for all my pack changes?
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.
How do I show that my pack design changes have been approved?
Following review by PAGB, if your pack design changes are approved, we will stamp your submission with a ‘PAGB Packaging Approval’ digital stamp. We will provide feedback on the statutory parts of your submission to support you in remaining compliant with 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.
- Design changes to the brand logo that appears at the top of the Patient Information Leaflet (PIL)
- Self-certified changes made alongside P3 changes can be grouped under a P3Ex submission
What isn’t included?
- 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 other than to the brand logo.
- Medical device and food supplement product packs are not covered under the P3Ex review. However, PAGB members can submit this packaging for assessment and advice via the firstname.lastname@example.org or email@example.com inboxes.
- PAGB can also provide support to non-members on a consultancy basis. If you’re looking for advice on your packaging, please contact us to discuss how we can support you.
How long will it take to review my pack?
We aim to complete assessment of your pack within five 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 medicines pack design for review?
Please email the following items to firstname.lastname@example.org, stating clearly that the submission is for P3Ex review.
- A copy of the currently approved pack design (all sides of pack to be included).
- A mock-up of the proposed pack design (all sides of pack to be included).
- A description of the updates made.
- A copy of the currently approved SmPC. If making design changes to the PIL please also submit a copy of the currently approved PIL.
- 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.
- Non-members should also include a purchase order number and billing address for invoicing.
Please note: if your attachments are larger than 25 MB it will not reach us. We recommend you use something like WeTransfer for attachments over 25 MB.
How much does PAGB’s medicines pack design pre-vetting service cost?
Product in membership? Free, it’s a benefit of being a member.
Fees apply for products not in membership, please email email@example.com for more information.