Uk MHRA Best Practice Guidance on the Labelling and Packaging of Medicines

Medicines labelling and packaging are fundamental to the safe and effective use of medicines. Clear packaging enables patients, carers, pharmacists, and healthcare professionals to correctly identify medicines, understand essential safety information, and minimise the risk of medication errors. Poor label design, confusing layouts, or lookalike packaging can contribute to dispensing mistakes and inappropriate medicine use.

To promote consistent and patient-focused packaging, the Medicines and Healthcare products Regulatory Agency (MHRA) has published the Best Practice Guidance on the Labelling and Packaging of Medicines. The guidance provides recommendations for designing medicine packaging that improves readability, supports medicine identification, enhances patient safety, and complies with the Human Medicines Regulations. It also offers practical guidance on presenting critical information, innovative pack design, Braille, QR codes, small containers, blister packs, and the appropriate use of non-statutory information.

Why This Guidance Is Important

The primary purpose of medicines packaging is to ensure the clear and unambiguous identification of medicines while presenting the information necessary for their safe use. The guidance recognises that medication errors can occur due to poorly designed labels, similar product names, or confusing packaging. By applying consistent design principles, manufacturers can improve readability, reduce lookalike-soundalike (LASA) confusion, and support safer medicine selection and administration.

The guidance applies to all MHRA submissions involving labelling, including new Marketing Authorisations, renewals, variations, notifications, and Product Information Quality Unit applications. Marketing Authorisation Holders are expected to incorporate these principles into their packaging designs and justify any deviations that could affect patient safety.

General Principles of Medicines Labelling

The guidance recommends that medicine labels present information in a logical, legible, and accessible format. Critical information should be grouped together and displayed prominently, avoiding interference from logos, graphics, or non-essential text.

Labels should use a minimum font size that supports readability while maintaining adequate spacing between lines. Information hierarchy is equally important, ensuring that the medicine name, strength, route of administration, dosage instructions, warnings, and other essential details are more prominent than less important information.

Where new packaging designs are introduced, manufacturers should ensure they improve medicine identification without increasing the risk of confusion among similar products.

Presenting Critical Information

The guidance identifies several elements as critical for the safe use of medicines, including the medicine name, strength, route of administration, dosage instructions, warnings, and indications where applicable.

The registered product name should be used consistently across all packaging components without abbreviation. Active ingredient names should appear immediately after the product name where required, while medicine strengths should be presented consistently across different product strengths to avoid confusion.

Routes of administration should be expressed as clear positive statements, such as "For oral use" or "For intravenous injection only," and dosage instructions should be presented appropriately depending on whether the medicine is prescription-only or available over the counter. Safety warnings should be displayed prominently whenever required by the Marketing Authorisation.

Braille and Accessibility

To improve accessibility, the guidance requires the product name to appear in Braille on the outer packaging of medicines intended for patient use. Braille should comply with recognised standards and be positioned without affecting the readability of printed information.

The guidance also recommends displaying the full product name on multiple faces of the outer carton wherever possible to improve visibility during storage and dispensing. These recommendations help support medicine identification for visually impaired patients while reducing the potential for dispensing errors.

Innovative Packaging Design and Colour

The MHRA encourages innovation in packaging design where it improves medicine identification and patient safety. Colours, typography, and graphical elements should assist users in distinguishing between products rather than serving purely decorative purposes.

The guidance discourages colour-coding medicines solely by strength because similar colour schemes may increase the risk of selection errors. Instead, manufacturers should consider overall package differentiation, particularly for products with lookalike-soundalike names or medicines commonly stored together. Innovative design should always prioritise safe medicine selection over marketing considerations.

Small Containers and Blister Packs

Recognising the limited space available on small containers and blister packs, the guidance provides specific recommendations for presenting essential information while maintaining readability.

Critical information such as the product name, strength, and route of administration should remain clearly visible, and labels should continue to meet minimum font size requirements. For blister packs, the medicine name and strength should ideally appear over each blister pocket or be repeated frequently throughout the foil to ensure product identification until the final dose is removed.

The guidance also recommends careful use of colour, avoidance of reflective materials where possible, and appropriate labelling for calendar packs to support patient adherence.

Non-Statutory Information and QR Codes

Additional information beyond statutory requirements may be included where it helps patients understand and use medicines safely without being promotional.

The guidance explains that symbols, pictograms, and QR codes may be used provided they support the approved product information and remain subordinate to mandatory labelling. QR codes should direct users only to information that is consistent with the approved Summary of Product Characteristics and Patient Information Leaflet, such as educational resources or authorised product information.

Manufacturers should also ensure that website links, email addresses, and other digital resources comply with MHRA requirements and do not introduce promotional content.

Best Practices for OTC Medicines

For over-the-counter medicines, packaging plays an even greater role in helping consumers select appropriate products without professional advice.

The guidance provides recommendations on presenting condition statements, indication wording, speed of action claims, formulation descriptions, safety information, and statements relating to specific patient groups. Claims should accurately reflect the approved product information and avoid implying guaranteed effectiveness or superiority over other products.

Similarly, "free from," "natural," "maximum strength," and formulation-related statements should only be used where fully supported by the approved product information and should never be misleading or promotional.

Symbols, Pictograms and User Testing

The guidance supports the use of symbols and pictograms where they help clarify approved information and improve patient understanding. Images of dosage forms, body parts, or age-appropriate patient groups may be used where they accurately represent the medicine and assist users in selecting the correct product.

The MHRA also encourages user testing, focus groups, and other evaluation methods when significant changes are made to packaging design. Testing helps confirm that healthcare professionals and patients can easily locate, understand, and act upon critical information before new packaging is introduced.

Following these best practices enables Marketing Authorisation Holders to develop packaging that supports regulatory compliance while enhancing the safe and effective use of medicines throughout their lifecycle.

References

• Best Practice Guidance on the Labelling and Packaging of Medicines