# Submit changes to labels and Patient Information Leaflets as a self-certification

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/a5d90c2d-54bc-4388-8d0b-c217661d5228
Type: Guidance
Published: July 3, 2026

> Guidance for submitting changes to labels and Patient Information Leaflets (PILs) as a self-certification.

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## Content

Regulation 267 of the Human Medicines Regulations (2012) sets out the requirement for the submission of mock-ups of packaging and leaflets to the licensing authority, as part of an initial licence application and subsequently to register any changes that are not connected with a change to the Summary of Product Characteristic (SmPC). The default route for registering changes to the label and/or leaflet is via a self-certification, unless the proposed updates fall into the categories P1-P4, where a full assessment is required.

## Attachments

- [Additional guidance for submitting changes to labels and patient information leaflets as a self-certification](https://assets.publishing.service.gov.uk/media/6a476e8e8effd97622f53be4/Supplementary_guidance_self-certification_Final_July_2026.pdf)