top of page

UK MHRA: Guidance on Packaging, Labelling and Patient Information Leaflets

Earlier today (08 March 2024) Medicines and Healthcare Products Regulatory Agency (MHRA) updated its "Guidance on Medicines: Packaging, Labelling and Patient Information Leaflets" in which it updated its submission for full assessment section (PE/P3EX to P3/P3EX).

This guide provides an in-depth overview of How to package medicines for sale and what information you must provide to consumers and healthcare professionals.

Labels must be clear and easily identifiable by healthcare professionals and patients. The use of the letters "CD" in an inverted triangle is encouraged for controlled drugs. All information on packaging for licensed medicines must be printed directly onto the packaging, and sample packs must be clearly labeled as "Free medical sample – not for resale."

From 1 January 2025, joint packs shared with other countries cannot enter the UK supply chain.

PILs must be easy to understand and must not contain personal information that can identify an individual. Each product authorized under a marketing authorization must have its own leaflets and alll medicines must have the name of the medicine displayed in Braille on the labelling. PILs must be made available for blind and partially-sighted patients.

Companies must inform the MHRA of all changes to the labelling and PILs of a product if those changes are not part of changes to the Summary of Product Characteristics (SmPC). A notification scheme is available for registering changes that do not require full assessment.

The submission of product information for full assessment and approval must include change codes on the application form. Changes falling under categories P1, P2, P3, P3EX, and P4 require submission for full assessment.

  1. Category P1 involves the first approval of mock-ups following a marketing authorization (MA) where only text-only versions were initially submitted.

  2. Category P2 includes changes to patient information leaflets (PILs) with significant changes to content or design, requiring continued compliance with user testing or bridging data.

  3. Category P3/P3EX pertains to changes in pack design, requiring submission for full assessment.

  4. Category P4 covers changes such as approval of artwork for new own-label suppliers, approval of artwork following a product name change, introduction of new safety information, or amendment of artwork following a patient safety complaint, all of which require a full application.

To understand in-depth what information you must provide to consumers and healthcare professionals, click the below LINK.


bottom of page