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)
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.
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.
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.
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.
Please email the following items to packdesign@pagb.co.uk
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.
Members and Associate Members | Free |
Non-Members
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£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. |