Blue Guide

The Blue Guide, Advertising and promotion of medicines in the UK, provides comprehensive guidance on the MHRA’s interpretation of the legal requirements for advertising medicines in the UK and how such advertising is regulated. It was first published in 1999 to explain the practical impact of the law and clarify its interpretation where necessary.

The Third Edition was published in August 2012. It reflects changes to the law relating to advertising of medicines, particularly following the consolidation of most medicines legislation in the Human Medicines Regulations 2012. It also includes updated guidance in a number of areas of concern, most notably providing information about unlicensed medicines or before the grant of an MA in section 4.2. There are new requirements for abbreviated advertisements and other changes to facilitate the use of online resources in chapter 6 and more information about digital communications. Information on making available non-promotional material for the public on prescription only medicines has been collected and extended into a single new chapter 7 and additional background information on the licensing system can be found in chapter 1. A number of guides covering specific areas are included as appendices. These are designed to provide detailed advice on the legislation relating to a particular topic, for example advertising of traditional herbal medicines, in an easily accessible form.

The guide is available below alternatively you can download a pdf version herePDF file (opens in new window) (630Kb)

Contents

1. General introduction

1.1 Introduction

1.2 Medicines regulation

1.3 Regulation of advertising

1.4 Development of the Blue Guide

1.5 Further information

2. How to complain

2.1 Introduction

2.2 When to complain

2.3 What will happen next?

Legal requirements for medicines advertising in the UK

3. The legislative framework

3.1 Introduction

3.2 The legal basis for the control of medicines advertising

3.3 Scope of the regulations

3.4 Other legislation relevant to medicines advertising

3.5 Where to get the legislation

4. General rules

4.1 Introduction

4.2 Prohibition on advertising unlicensed medicines

4.3 Quality standards

4.4 Who is responsible?

4.5 Updating advertising

4.6 Keeping records

4.7 Special requirements for traditional herbal medicinal products (THMs)

4.8 Special requirements for homeopathic medicines

5. Advertising to the public

5.1 Introduction

5.2 Medicines suitable for advertising to the public

5.3 Prohibition of certain material

5.4 Children

5.5 Information necessary for the correct use of a medicine

5.6 Advice on claims

5.7 Recommendations and endorsements

5.8 Sponsorship

5.9 Samples for promotional purposes

5.10 Advertising using digital communications media and the internet

5.11 Multiple purchase promotions for analgesics

6. Advertising to persons qualified to prescribe or supply medicines

6.1 Introduction

6.2 Scope of "persons qualified to prescribe or supply" medicines

6.3 Advertising on the Internet

6.4 Provision of information – full advertisements

6.5 Provision of information - abbreviated advertisements

6.6 Safety messages given in advertising

6.7 Urgent safety restrictions or safety variations

6.8 Trade advertisements

6.9 Promotional aids

6.10 Advertising intended for international publication

6.11 International meetings

6.12 Professional samples

6.13 Medical sales representatives

6.14 Gifts, inducements and other benefits

6.15 Interpretation of "inexpensive" and "relevant to the practice of medicine or pharmacy"

6.16 Hospitality

6.17 Provision of medical or pharmaceutical education, goods and services

6.18 Co-promotion

7. Providing non-promotional information about prescription only medicines to the public

7.1 Introduction

7.2 Independent information sources

7.3 Promotion of services

7.4 Disease awareness and health education campaigns

7.5 Company internet sites

7.6 Materials for patients

7.7 Press releases and other information to the media

7.8 Responses to enquiries from the public

Regulation of medicines advertising in the UK

8. The role of the MHRA

8.1 Introduction

8.2 Vetting of advertising material

8.3 Scrutiny of current advertising material

8.4 Complaints about medicines advertising

8.5 Corrective statements

8.6 Seeking advice on advertising

9. Statutory action

9.1 Introduction

9.2 Taking statutory action

9.3 Independent Review Panel (IRP)

9.4 Determinations

9.5 Sanctions

10. Self regulation

10.1 Introduction

10.2 The regulatory regime

10.3 Vetting of advertising material

10.4 Investigation of complaints

10.5 Medicines Advertising Liaison Group (MALG)

Annex 1: The Principal UK legislation for the advertising and monitoring of medicines

Annex 1: Other legislation that affects medicines advertising

Annex 1: UK legislation for Homeopathic Medicines with Product Licences of right

Annex 1: European directives

Annex 2: Implementation of title VIII of directive 2001/83/EC UK law

Annex 3: Particulars to be included in advertisements to the public

Annex 4: Particulars to be included in advertisements to persons qualified to prescribe or supply

Annex 5: Particulars to be contained in abbreviated advertisements

Annex 6: Other regulatory and self-regulatory bodies

Guides

Appendix 1: Registered traditional herbal medicines: guidance on consumer advertising

Appendix 2: Homeopathic medicines: guidance on advertising

Appendix 3: Medicines which are promoted for use during pregnancy: guidance for the pharmaceutical industry

Appendix 4: Best practice guidance on the sale of medicines for pain relief

Appendix 5: Reporting to the public on medicines: advice for journalists and patient organisations

Appendix 6: Advertising of medicines: guidance for consumer websites offering medicinal treatment services

Appendix 7: Disease awareness campaign guidelines

Appendix 8: Guidance on review of advertising by an independent review pane

Glossary


Page last modified: 08 May 2013