The Critical Health Information Panel

Labelling must contain all elements required by Article 54 of Council Directive 2001/83/EEC.

Article 56 of Council Directive 2001/83/EEC states that the particulars referred to in Articles 54, 55 and 62 shall be easily legible, clearly comprehensible and indelible.

This Code of Practice should be read alongside the legislative requirements as set out in Council Directive 2001/83/EC, Article 54. The outer packaging of medicinal products is required to include the information set out below. It is a legal requirement for companies to submit full colour actual size mock-ups of packaging to the MHRA as part of an application for a Marketing Authorisation, a variation to an existing Marketing Authorisation which affects the information on the label or an application or notification submitted under Article 61(3) of Council Directive 2001/83/EC to propose changes to the label not impacting on the SmPC.

Statutory Label Requirements

(Article 54 of Council Directive 2001/83/EC)

  1. The name of the product, followed by the strength and pharmaceutical form and, if appropriate, if it is intended for babies, children or adults. Where the product contains up to three active substances, the INN shall be included or if one does not exist, the common name
  2. A statement of the active ingredients of the product expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a given volume or weight, using the common names of the ingredients.
  3. The pharmaceutical form of the product and the contents of the product by weight, by volume or by number of doses of the product.
  4. A list of excipients known to have a recognised action or effect and included in the detailed guidance published under Article 65 of the Directive. However, if the product is injectable or a topical or eye preparation, all excipients must be stated.
  5. The method and, if necessary, the route of administration of the product.
  6. A special warning that the product must be stored out of sight and reach of children.
  7. Any special warnings required by the product licence for the product concerned.
  8. The expiry date of the product (stating the month and year) in clear terms.
  9. Any special storage precautions for the product.
  10. Any special precautions for the disposal of any unused products or waste materials derived from such products.
  11. The name and address of the holder of the Marketing Authorisation.
  12. The number of the Marketing Authorisation – in the UK, this is preceded by the letters PL.
  13. The manufacturer’s batch reference.
  14. Where a product is intended for self medication, any instruction on the use of the product. For OTC medicines, this includes the authorised indications.

Additional information which may be included on medicine labels pursuant to Article 62 of Council Directive 2001/83/EC:

  • Symbols or pictograms designed to clarify certain information
  • Other information compatible with the SmPC, which is useful for the patient, to the exclusion of any element of a promotional nature.

The critical health information panel presenting the statutory information

The Best Practice Guidance on the Labelling and Packaging of Medicines1 issued by MHRA makes reference to the “critical information” which is necessary at the point of use and recommends that this information is placed together on the pack in the same field of view. This is largely followed already by OTC manufacturers. Various names have been used for the panel on the pack which includes this information. PAGB proposes calling it the “critical health information panel”. The advice given in this section draws on the MHRA Best Practice Guidance and the National Patient Safety Agency Guidance.2

While labelling must contain all elements required by legislation, the critical information which must appear in the same field of view is:

  • Name of the medicine
  • Expression of strength
  • Pharmaceutical form
  • Route of administration
  • Authorised indications
  • Dosage
  • Warnings

Where space constraints make it difficult to fit all the statutory information on to one face of the label, priority should be given to this information. These items of information should be located together on the pack and should not be broken up by additional information, logos or background texts or graphics. The following information gives guidance to help companies produce information which is clear and legible. It has no statutory basis and it will be amended by PAGB in co-operation with the MHRA as experience with the Code develops and feedback from tests with consumers provides new information.

  • Do not place text in the critical health information panel over images or logos
  • Fitting text around or over images or logos breaks the flow of information and makes it difficult for patients to read
  • Create a strong contrast between text and background colour.

People find it easier to read dark coloured type (e.g. black or dark blue on a light coloured background e.g. white, pale pink, pale yellow). Strongly reflective packs also present difficulties for readers and companies who wish to use coloured or reflective backgrounds must ensure that the type chosen is still readable. Testing the packs with users can give helpful information in this respect but this is not mandatory.

Use of the product name

The full product name, including the common name(s) of the active(s), must appear once in the critical health information panel. If it is used often then it could use up space that would reduce the area available for other essential information or force the use of a smaller font size than would otherwise be necessary.

References:

1. MHRA, 2003, Best Practice Guidance on Labelling and Packaging of Medicines

2. National Patient Safety Agency, 2006, Information Design for Patient Safety