Changes to Labels and Patient Information Leaflets - Self-Certification Process

Key changes

Provides additional procedural details and requirements for using the self-certification route for labelling and PIL updates, ensuring faster implementation of administrative and certain safety-related changes.

PV impact

MAHs can utilize this streamlined process for specific types of labelling updates, potentially reducing the time required to implement safety-related changes in the PIL and on packaging.

Exact policy details

Default route for registering changes to labels and leaflets

Self-certification

Applies to: Applicable unless changes fall under categories P1-P4

Regulation 267 of the Human Medicines Regulations (2012) · p. 1 · High · Source

Timeframe for acceptance letter after self-certification submission

14 days

Applies to: After validation of submission

Submission decision tree section · p. 3 · High · Source

Timeline for expedited review for OTC medicines with PAGB

30 days

Applies to: When an optional submission has been made to PAGB

P2 category section · p. 2 · High · Source

Categories requiring full assessment instead of self-certification

P1-P4

Applies to: Proposed updates that fall into these categories

What changes fall into the P1-P4 categories section · p. 2 · High · Source

Supporting documents for self-certification

eCTD documentation

Applies to: Required for all self-certification submissions

How to submit – documentation required section · p. 4 · High · Source

Extracted documents

• Submit changes to labels and Patient Information Leaflets as a self-certificationhtmlhtml · high · 1 page
• https://assets.publishing.service.gov.uk/media/6a476e8e8effd97622f53be4/Supplementary_guidance_self-certification_Final_July_2026.pdfpdfpdf_text · high · 11 pages