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Guidance: Medicines: packaging, labelling and patient information leaflets

Medicines Healthcare Products Regulatory Agency

December 22
12:23 2023

Overview

The MHRA approves all packaging and labelling information for medicines sold in the UK including the information that must be provided. Medicines must include a patient information leaflet (PIL) if the label does not contain all the necessary information.

You should read the relevant UK legislation before making an assessment submission.

Guidelines on the readability of the label and package leaflet of medicinal products for human use is available on the European Commission website and will remain relevant after transition.

Labelling for medicines

Labels must be clear. Healthcare professionals and patients must easily be able to identify the medicine by the label.

You should use the letters CD in an inverted triangle if your product is a controlled drug. This isnt compulsory but we encourage you to include this mark on your products labelling.

All information on packaging for licensed medicines must be printed directly on to the packaging. Over-labelling must not be used.

Sample packs must have Free medical sample not for resale or similar wording on the outer packaging. Over-labelling must not be used.

From 1 January 2025, joint packs, also known as common or shared packs, can no longer enter the UK supply chain. A joint pack is one that is shared with another country or countries, and which presents administrative details for both the UK and the other markets sharing the pack. From this date, medicines must be packaged in a UK-specific outer carton that is labelled UK only. Shared inner packaging components, such as multi-lingual blister foils and joint leaflets may continue to be used, provided that the UK and EU licences remain aligned. Please see our guidance on Labelling and packaging of medicinal products for human use following agreement of the Windsor Framework.

Patient information leaflets (PILs)

Unless all the information is on the pack, all medicines must include a PIL, regardless of how patients get them. PILs must:

  • be easy to understand
  • not contain personal information that can identify an individual, including names of staff members or digital signatures

Each product authorised under a marketing authorisation must have its own leaflet as explained in our best practice guidance on patient information leaflets. Also see MHRA guidance document always read the leaflet - getting the best information with every medicine (PDF, 588 KB, 173 pages).

Our assessment of PILs includes a review of the font, colours, text size and layout of the information to assure the accessibility and readability of the statutory information.

Warnings on labels and leaflets for medicines

Labels must include warnings for safe use of the medicine. All products that contain paracetamol must include statutory warnings. Additional warning statements must be included on the packaging of specified medicines.

You should include these warnings when making an application to register labelling and/or leaflets with us. Deviations from the proposed wording must be fully justified in your submission.

Braille on labelling and in PILs

All medicines must have the name of the medicine displayed in Braille on the labelling.

You must make you PILs available for blind and partially-sighted patients.

Braille can appear on more than one side of a products carton. You must not use abbreviated Braille. Braille can appear on printed areas of the carton, as long as the underlying text is clear and visible.

You can submit changes to Braille on the labelling through a notification.

Guidance

From 2016 the official Braille code in the UK is the Unified English Braille code (UEB)

Guidance concerning the braille requirements for labelling and the package leaflet

The British Standards Institute has guidance on the application of braille to the labelling of medicines.

Child-resistant packaging for medicines

Child-resistant packaging is used to make it difficult for young children to open medicines but easy for adults to use.

Packaging must be child-resistant if the medicine contains:

  • aspirin
  • paracetamol
  • more than 24mg of elemental iron

You dont need to provide child-resistant packaging if your product is:

  • effervescent
  • in single dose units

An MA or variation must demonstrate that child-resistant packaging meets international standards for reclosable or non-reclosable containers:

  • reclosable packaging consists of container-closure systems that, when the closure is removed, permit access to more than 1 dosage unit and can be reassembled to form a child-resistant pack; reclosable containers must comply with international standard BS EN ISO 8317

  • non-reclosable containers are container-closure systems that once opened cant be reassembled to form a child-resistant package such as blister packs; such non-reclosable packs must must comply with international standard BS EN 14375

The British Standards Institute has published a consumers guide to the standards for child resistant packaging.

If aspects of the packaging system change, it may be necessary to vary the MA and include additional evidence that the new packaging system has been shown to comply with relevant international standards.

Factors that can affect the child resistant properties of a container-closure system include:

  • change in foil material
  • change in blister material
  • change in adhesive
  • different orientation of blister pockets
  • different wadding materials in closures
  • inclusion of a liquid medicine in a container-closure system previously used for solid dosage forms

Submit information for full assessment

Product information which needs a submission for full assessment and approval must include change codes on the application form.

P1

First approval of mock-ups following a granting of a MA where only text-only versions were submitted and approved as part of the MA application.

P2

Changes to PILs which include significant changes to content and/or design and layout and must show continued compliance with user testing or bridging data. Changes to the leaflet in line with article 62 (allowing a MA holder to include extra statutory information on the label and in the PIL) also fall into this category.

PE/P3EX

Changes to pack design must always be submitted for full assessme

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