Labels, patient information leaflets and packaging for medicines

Information on how a medicine should be used is provided to doctors and pharmacists in the Summary of Product Characteristics (SPC). Information to patients or consumers is provided on the label and, more recently, by patient information leaflets (PILs) - unless all the necessary information can be included on the label. All medicines in the UK have labels and/or PILs approved in line with Title V of Council Directive 2001/83/EC.

• The Unit assesses labels and PILs provided by the pharmaceutical industry for compliance with the Regulations (Directive 2001/83/EC) After assessment, and approval by the Unit, the pharmaceutical companies must use the labels and PILs in the packaging of their medicines. For further information,  please see Legislation and guidelines.
• The Unit assesses supplementary 'health educational' material that can be obtained by patients prescribed a particular medicine. For example, videos, magazines and literature sent out when the patient enrols in a 'patient club'. All health education material must be strictly non-promotional and we liaise closely with the Advertising Unit for this work. 
• The Unit responds to correspondence from members of the public received by Members of Parliament, the Health Minister and Secretary of State for Health regarding patient information and advises as appropriate.

Medicines can be obtained in three ways: 

• From a retail outlet such as a supermarket with no input from a health professional at the point of sale. 
• From a pharmacy, where the product can only be sold under the supervision of a pharmacist who will advise the patient on how to use the medicine. 
• On prescription, following consultation with a doctor and the pharmacist at the point of dispensing.
  

The provision of good quality patient information is intended to supplement and not replace the advice given to patients by health professionals.   Every patient should be given a patient information leaflet with each medicine regardless of whether these are purchased over the counter, supplied on prescription or administered by a health professional.

For patients that purchase their medication from retail outlets, patient information represents the only advice the patients receive on how to take their medicine safely and effectively.

Patient information must be written in clear and understandable terms.  New requirements have recently been introduced requiring those responsible for the writing of statutory patient information leaflets to make sure that these have been drawn up to take into account the needs and views of patients.   Presentation of information in terms of print size, colour and layout is an important factor in overall 'readability'.  Guidance on this has been produced by the MHRA and published in “Always Read the Leaflet – getting the best information with every medicine”. (602Kb) This publication also includes details of how to comply with the new requirements concerning “user testing” – taking account of patients views. 

For details of the Guideline on the readability of the label and package leaflet of medicinal products for human use, published by the European Commission, please see the Legislation and guidelines section.

Labelling
Clear labelling is crucial for the safe use of all medicines and its primary purpose is for the clear and unambiguous identification of the product and the conditions for safe use.  Similarity in packaging is known to contribute to medication error and MHRA has published guidance for those involved in the design and layout of labelling to help improve the way in which labelling information is presented both to health care professionals and patients.  This guidance applies to medicines available on prescription and also over the counter.

› 'Best Practice Guidance on labelling and packaging of medicines' (226Kb)

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.