Labels, patient information leaflets and packaging of medicines: Legislation and guidelines

The regulations covering labelling and patient information leaflets are set out in Title V of Council Directive 2001/83/EC which was amended by Council Directive 2004/27/EC.   (Please see Related information (other sites) for copies of the Directives.)

Recent amendments to the requirements include:

• The introduction in Article 54(a) for up to three active substances to be included immediately after the registered name on the front of pack label.
• The introduction in Article 54(e) for space for the prescribed dose to be added to the label.  In the UK this should be a blank space 35 mm by 70 mm to allow the pharmacist to apply a dispensing label.
• The introduction of Article 56a into the Directive makes provision for the name of the medicinal product to be expressed in Braille format on the packaging. Additionally, the Patient Information Leaflet (PIL) should be provided in formats suitable for the blind or partially-sighted. This was implemented in October 2005 and consultation on these new requirements and further guidance will be published in the near future.
• Amendments to Article 59 of the Directive include a new order for the required information to appear in the PIL. This is drawn up in accordance with the Summary of Product Characteristics (SPC).
• Further amendments to Article 59 require consultation with target patient groups to ensure that the PIL is legible, clear and easy to use (user testing).

Amendments to articles 54 and 56 have been implemented into UK legislation via the Statutory Instrument SI 2005/2759 and affect all new applications submitted to the Agency from 30 October 2005.  Existing marketing authorisations have until 30 October 2010 to comply.   Guidance has been developed in this area and is available in the Braille section.

Amendments to article 59 have been implemented into UK legislation via the Statutory Instrument SI 2004/3224 and affect all new applications submitted to the Agency from 1 July 2005. Existing marketing authorisations have until 1 July 2008 to comply. We have published the following guidance and questions and answers to assist companies comply with the new requirements on patient consultation which are available in the user testing section.

› Article 65 of the Directive makes provision for the publication of guidelines to be used in conjunction with the Directive. 

Excipients in the label and package leaflet of medicinal products for human use.
The revised version (July 2003) is in 'The rules governing medicinal products in the European Union. Volume 3BC7A (see Related information (other sites)).
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› A guideline on the readability of the label and package leaflet of medicinal products for human use   (external link)
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Best Practice Guidance on the labelling and packaging of medicines (226Kb)
From 1 March 2003 all labelling received by the Agency associated with a new marketing authorisation application will be considered against this guidance document.

Contact for further information
The Unit responds to and investigates enquiries and complaints regarding patient information reported by members of the public and the pharmaceutical industry. Enquiries and complaints should be made in writing and sent to: The Patient Information Quality Unit, MHRA, 14-1, Market Towers, 1 Nine Elms Lane, Vauxhall, London SW8 5NQ or e-mail patient.information@mhra.gsi.gov.uk.