This section provides details of the legislation and guidelines in the UK relating to the regulation of labels and leaflets.
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.
Patient information leaflets-revision date
Article 59(1)(h) requires the leaflet to include a 'revision date' at the end of the document. All applications (new MAA, variations, renewals, applications and notifications made under article 61(3) of Council Directive 2001/83/EC) must be accompanied by a leaflet which includes the date on which the applicant revised the leaflet.
This should reflect the date on which the submission was presented to the agency and should be in the format mm/yyyy. I
f as a result of the assessment process the PIL is amended and a revised document submitted, the revision date should be altered to reflect the date of the response to the request for further information along with the other changes requested.
Applicants should be aware that failure to include this information at the time of submission or response to questions could lead to delays in processing.
For further information contact:
patient.information@mhra.gsi.gov.uk
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).
A guideline on the readability of the label and package leaflet of medicinal products for human use (external link)
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.
Signposting from the patient information leaflet to additional sources of information and other services (69Kb)
Guidance has been developed on the signposting to additional sources of information.
Labelling and packaging of medicines: Quick Response (QR) codes (37Kb)
This document sets out advice on the inclusion of Quick Response (QR) codes on labelling and packaging.
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, 151 Buckingham Palace Road, London Sw1W 9SZ or email patient.information@mhra.gsi.gov.uk
