Best practice in the labelling and packaging of medicines

Key changes

Updated recommendations for the design, layout, and content of medicines labelling and packaging, with a focus on risk minimisation and the clarity of safety warnings.

PV impact

Marketing Authorization Holders (MAHs) must ensure that product labelling and packaging align with these updated best practices to support risk management and safety communications. This may require updates to existing labelling SOPs and artwork review processes.

Exact policy details

Font Size Requirement

7 points minimum (lower case 'x' must be at least 1.4 mm in height)

Applies to: All labelling components for all medicines

Section 4.1 · p. 6 · High · Source

Critical Information Requirements

Must include name of the medicine, expression of strength, route of administration, posology, warnings, and indications (for OTC only)

Applies to: All labelling components for all medicines

Section 4.2 · p. 7 · High · Source

Approval and Introduction of New Packaging

New packaging components must be introduced into packed stock within six months of approval

Applies to: Marketing Authorisation Holders (MAHs)

Section 3 · p. 3 · High · Source

User Testing Recommendation

User testing is recognized as best practice but is not legally required

Applies to: Pharmaceutical industry during major layout changes

Section 4.8 · p. 10 · High · Source

Workflow rule impacts

Extracted documents

• Best practice in the labelling and packaging of medicineshtmlhtml · high · 1 page
• https://assets.publishing.service.gov.uk/media/6a4770118effd97622f53be5/Best_practice_guidance_labelling_MHRA_Final_July_2026.pdfpdfpdf_text · high · 23 pages