The Blue Guide

The Blue Guide

Advertising and Promotion of Medicines in the UK

Medicines and Healthcare products Regulatory Agency

Third Edition

Third revision - November 2020

THE BLUE GUIDE

ADVERTISING AND PROMOTION OF

MEDICINES IN THE UK

Medicines and Healthcare products Regulatory Agency Third Edition

Third revision - November 2020

MHRA Contact Points for Advice on Advertising and Promotion of Medicines

Advertising Standards and Outreach Unit Medicines and Healthcare products Regulatory Agency 10 South Colonnade LONDON E14 4PU

General advice and information on advertising and promotion of medicines, including a copy of this guidance, is available on the MHRA website at .uk.

For general enquiries about advertising Email: advertising@.uk of licensed medicines and legislation Tel: 020 3080 6523/6452

For enquiries about advertising policy Email: advertising@.uk Tel: 020 3080 6765/7771/6039

For general enquiries about the MHRA:

Customer Services

E-mail: info@.uk Tel: 020 3080 6000

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Record of changes - Third edition

The Third Edition of the Blue Guide was published in August 2012. It has been made available as an online resource rather than a printed publication with the expectation that it would be a dynamic document updated at regular intervals as required.

The following three specific updates have been made since 2012:

September 2014:

1. Changes to reflect the Human Medicines (Amendment No. 2) Regulations 2014 to simplify the information requirements for advertising to healthcare professionals and other suppliers of medicines (primarily sections 6.4 and 6.5 and annexes 1, 4 and 5).

2. Additional advice on prohibited gifts and benefits (section 6.14) 3. Updated guidance for providers offering medicinal treatment services

(section 7.3 and appendix 6). 4. Updated information about adverse drug reaction reporting (section 7.6). 5. Additional clarification concerning advertising of medicines for use in

pregnancy (Appendix 3). 6. Updates to contact details for MHRA staff and information about NICE,

ABPI and PMCPA.

July 2019:

1. Addition of information about General Pharmaceutical Council guidance and the Distance Selling Logo to the guidance for providers offering medicinal treatment services (appendix 6).

2. Removal or updating of references to the Office of Fair Trading (sections 3.4 and 10.2) and updated information about Radiocentre (section 10.3).

3. Update to MHRA contact details.

November 2020:

1. Changes to permit limited advertising in certain types of public health emergency, reflecting the Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (section 5.2).

2. Changes to include new licence categories for Great Britain and Northern Ireland and reflect the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 as amended by the Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (primarily sections 4.2, 5.5, 6.4 and Annex 3) and removal of references to European law.

3. Additional advice on samples (section 6.12) and `clinically proven' claims and free offers (Appendix 6) and updated information on the Medicines and Devices Advertising Liaison Group (section 10.5).

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CONTENTS

Chapter 1

GENERAL INTRODUCTION

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1.1 Introduction

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1.2 Medicines regulation

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1.3 Regulation of advertising

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1.4 Development of the Blue Guide

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1.5 Further information

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Chapter 2

HOW TO COMPLAIN

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2.1 Introduction

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2.2 When to complain

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2.3 What will happen next?

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LEGAL REQUIREMENTS FOR MEDICINES ADVERTISING

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IN THE UK

Chapter 3

THE LEGISLATIVE FRAMEWORK

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3.1 Introduction

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3.2 The legal basis for the control of medicines advertising

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3.3 Scope of the Regulations

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3.4 Other legislation relevant to medicines advertising

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3.5 Where to get the legislation

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