Your guide to PAGB's pre-vetting pack design service (P3 expedited MHRA approval)

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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)


letter i indicating informationPAGB’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:

What isn’t included?

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 medicines pack design for review?

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

  1. A copy of the currently approved pack design (all sides of pack to be included).
  2. A mock-up of the proposed pack design (all sides of pack to be included).
  3. A description of the updates made.
  4. A copy of the currently approved SmPC. If making design changes to the PIL please also submit a copy of the currently approved PIL.
  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 PAGB’s medicines pack design pre-vetting service cost?

Full members  Free – it’s a benefit of membership
 

Standard price

 

 

£100 plus VAT at 20% per design review

Reviews of different pack sizes for the same product and subsequent reviews including updated versions will be charged the full review fee.