The new Pharmacovigilance Directive [Council Directive 2010/84/EC] requires the European Commission (EC) to produce a report on the shortcomings of product information and to bring forward proposals for legislative change. The advice of the Commission on Human Medicines (CHM) has informed an open letter setting out the UK position, sent to both the EC and the research organisation contracted to produce the report envisaged by the Directive.
The Patient Information Quality Unit is part of the Vigilance and Risk Management of Medicines (VRMM) Division. The Unit is responsible for policy and regulation of all types of product information.
Information on how a medicine should be used is provided to doctors, pharmacists and nurses 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 registered 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 enrolls in a 'patient club' or obtains further information in line with article 62 of Council Directive 2001/83/EC via other media 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.
- The unit provides advice internally to assessor colleagues in the operating divisions.
- PIQU also offers a scientific advice service in line with agency procedures for which a fee is levied, please see section on scientific advice for licence applicants
This page provides an overview of information related to labels, patient information leaflets and packaging for medicines.
Overview of labels, patient information leaflets and packaging for medicines
Applications for assessment
Braille on labelling and in patient information leaflets
Patient Information Quality Unit (PIQU) performance figures
Legislation and guidelines
Patient information leaflet (PIL) of the month
Child resistant packaging
This section provides information on child resistant packaging.