Labels, patient information leaflets and packaging for medicines

 

Control of lisdexamfetamine, tramadol, zaleplon, zopiclone and reclassification of ketamine

For controlled drugs, outer and immediate packaging subject to full labelling requirements, present the following symbol adjacent to the declaration of legal status (POM). This additional symbol is included on a voluntary basis.

Controlled substance logo

Marketing authorisation holders for medicines listed in Schedules 2 and 3, including lisdexamphetamine and tramadol containing medicines should update their packaging as soon as possible, so that packs produced after 10 June 2014 include this symbol.

Updated labelling may be submitted to MHRA via a notification procedure.


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

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This page provides more information on labels, patient information leaflets and packaging for medicines.
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Applications for assessment

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This page gives details of applications for assessment for labels and leaflets.
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Braille on labelling and in patient information leaflets

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This section provides guidance concerning the braille requirements for labelling and the package leaflet.
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Complaints

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This section describes the process the MHRA follows in handling complaints about the labelling and packaging of medicines.
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Patient Information Quality Unit (PIQU) performance figures

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Information on the Patient Information Quality Unit (PIQU) performance figures.
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Legislation and guidelines

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This section provides details of the legislation and guidelines in the UK relating to the regulation of labels and leaflets.

Notification scheme     

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This section provides details of self certification requirements by the applicant and formal notification to the MHRA.

Patient information leaflet (PIL) of the month

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This section provides information on Patient information leaflets (PILs) as well a selection of  leaflets demonstrating best practice.

FAQs

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Frequently asked questions about labels, patient information leaflets and packaging for medicines.

Child resistant packaging

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This section provides information on child resistant packaging.

Page last modified: 19 June 2014