UK MHRA Guidance: Medicines Packaging, Labelling, Patient Information Leaflets and Guidance on How to Submit Changes to Labels & PILs as a Self-Certification

Medicines packaging, labelling, and Patient Information Leaflets (PILs) are essential components of medicine safety and regulatory compliance. They provide healthcare professionals and patients with critical information regarding the safe use, storage, administration, and identification of medicinal products. Throughout a medicine's lifecycle, these materials must remain accurate, up to date, and consistent with the approved product information to support patient safety and reduce the risk of medication errors.

To help Marketing Authorisation Holders (MAHs) meet these obligations, the Medicines and Healthcare products Regulatory Agency (MHRA) has published two complementary guidances.

Medicines Packaging, Labelling and Patient Information Leaflets and Self-Certification for Changes to Labels and Patient Information Leaflets.

The first establishes the regulatory requirements for medicines packaging, labelling, and patient information leaflets, while the second explains how eligible changes to labels and PILs can be submitted through a self-certification process instead of a full regulatory assessment.

Guidance: Medicines Packaging, Labelling and Patient Information Leaflets

Why This Guidance Is Important

Packaging and labelling are more than regulatory requirements—they are essential tools for communicating critical information about medicines. Well-designed labels and patient information leaflets help patients use medicines correctly, enable healthcare professionals to identify products accurately, and ensure that important warnings, dosage instructions, storage conditions, and safety precautions are clearly presented.

The MHRA guidance establishes standards for packaging design, labelling content, patient information leaflets, accessibility requirements, and regulatory submissions, ensuring that medicine information remains accurate, consistent, and easy to understand throughout the product lifecycle.

Packaging, Labelling and Patient Information Requirements

Medicine packaging should protect the product while presenting mandatory information in a clear and legible format. Labels should include essential product details such as the medicine name, strength, pharmaceutical form, storage instructions, expiry date, batch number, and other statutory information required under UK legislation.

Patient Information Leaflets should provide patients with easy-to-understand information covering the medicine's purpose, dosage instructions, precautions, contraindications, possible side effects, storage recommendations, and guidance on reporting adverse reactions. The leaflet should accurately reflect the approved Summary of Product Characteristics (SmPC) while using a layout that enables patients to locate important information quickly.

The guidance also highlights the importance of incorporating mandatory safety warnings, Braille on outer packaging where applicable, and child-resistant packaging for medicines that require additional protection. When significant updates to packaging or patient information are proposed, manufacturers may need to submit revised artwork for full regulatory assessment to ensure continued compliance with UK medicines legislation.

By maintaining accurate packaging and patient information throughout a product's lifecycle, Marketing Authorisation Holders help improve patient understanding, reduce medication errors, and support the safe use of medicines.

Guidance: Self-Certification for Changes to Labels and Patient Information Leaflets

Purpose of the Self-Certification Process

As authorised medicines evolve, manufacturers often need to make routine updates to packaging artwork and Patient Information Leaflets. Many of these changes are administrative or minor in nature and do not affect the approved Summary of Product Characteristics or alter the safe use of the medicine.

To simplify the regulatory process for these lower-risk updates, the MHRA introduced the self-certification procedure. This pathway allows eligible changes to be registered efficiently while ensuring that significant modifications affecting patient safety, readability, or medicine identification continue to undergo a full regulatory assessment.

When Self-Certification Can Be Used

Self-certification is generally appropriate for routine artwork updates that do not significantly alter the design, content, or readability of labels or patient information leaflets.

Examples include correcting typographical errors, updating Marketing Authorisation Holder or distributor details, revising statutory wording to align with current legislation, updating storage statements where the meaning remains unchanged, adding approved Braille, incorporating recycling symbols, modifying barcode information, and making minor formatting or technical artwork adjustments.

Applications should be submitted electronically using the appropriate documentation together with consolidated artwork files that replace the currently approved versions, ensuring that the regulatory record reflects the complete and final packaging and leaflet materials.

Changes Requiring Full Assessment

Not every artwork update is suitable for self-certification. Significant modifications continue to require full MHRA assessment before implementation. These include first approval of packaging mock-ups following a marketing authorisation, major changes to patient information leaflets requiring user testing, substantial redesign of packaging layout, significant changes affecting readability or product identification, and safety-related updates specifically requested by the MHRA.

The guidance encourages manufacturers to assess each proposed change carefully before submission to determine whether it qualifies for self-certification or should follow the full regulatory approval pathway. Selecting the appropriate submission route helps maintain regulatory compliance while avoiding unnecessary delays in implementing approved artwork changes.

By following both guidances, Marketing Authorisation Holders can maintain compliant product information, support patient safety, and facilitate efficient regulatory management of authorised medicines.

References

• Medicines Packaging, Labelling and Patient Information Leaflets

• Self-Certification for Changes to Labels and Patient Information Leaflets