Spring Intro 2023

Types of submission you can make

There are two types of submission that you can make for the approval of updated labels and/or patient information leaflets.

1. Notification (self-certification): This is the default submission route and should be used for all changes that do not fall within the P1-P4 categories described in MHRA guidance.

2. Submission for full assessment: For changes that fall into the P1-P4 categories

https://www.gov.uk/government/publications/submitting-changes-to-labelling-and-patient information-leaflets

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Changes requiring professional assessment and approval (1/2)

• Competent authority has 90 days consider the request

• P1: First approval of mock-ups following grant of a marketing authorisation where only text versions were submitted and approved as part of the MAA

• P2: Changes to patient information leaflets which include significant changes to content and/or design and layout and must therefore be supported by additional data (user testing or bridging report) or additional information in connection with the addition of extra statutory information.

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