Advertising of medicines

General information

Advertising can be presented in several forms, including:

• medical journals
• magazines
• newspapers
• television advertisements
• Internet advertising
• posters in London underground trains.  

The MHRA's Advertising Standards Unit routinely scrutinises medical journals, magazines to the general public and also the Internet for the promotion of licensed medicines. Also, advertising is selectively checked prior to issue, complaints are investigated, and advice is provided to industry, health professionals and other regulatory bodies. The Unit also provides advice to several sections within the Vigilance and Risk Management of Medicines Division, in particular relating to product information.

The advertising of medicines is controlled by a combination of statutory measures (with both criminal and civil sanctions), enforced by the MHRA and self-regulation through Codes of Practice for the pharmaceutical industry, administered by trade associations. The MHRA as Licensing Authority has a statutory duty on behalf of Ministers to consider breaches of The Medicines Act 1968 and Regulations on the promotion of medicines. Its key function is to protect public health by promoting the safe use of medicines, ensuring that they are honestly promoted as to their benefits, uses and effects, in compliance with current legislation.

The legal base for the control of advertising is contained in The Medicines (Advertising) Regulations 1994 and The Medicines (Monitoring of Advertising) Regulations 1994, both as amended. The Regulations implement Title VIII of Directive 2001/83/EC on the advertising of medicines for human use.  A list of the legislation relevant to medicines advertising can be accessed below:
Advertising of medicines: The legislative framework

The Regulations lay out different requirements for advertising to the public and advertising to health professionals. Advertising to the public is permitted for medicines legally classified pharmacy sale (P) or general sale list (GSL). The Regulations prohibit the issue of any advertisement to the general public which is likely to lead to the use of a prescription only medicine (POM).  Advertising issues are, in the majority of cases resolved administratively, with prosecution reserved for serious cases, for example, where there is a safety issue or a company is uncooperative or repeatedly offends.

Annual reports on advertising

These annual reports are published to meet a commitment given to the Health Select Committee as part of the Government response to their report on ‘The influence of the Pharmaceutical Industry’. It aims to contribute to the Agency's policy of transparency in the regulation of medicines advertising.

Delivering High Standards in Medicines Advertising Regulation - Annual Report January - December 2011 (113Kb)
Delivering High Standards in Medicines Advertising Regulation - Annual Report September 2009 - December 2010 (164Kb)
Delivering High Standards in Medicines Advertising Regulation - Annual Report September 2008 – August 2009 (379Kb)
Delivering High Standards in Medicines Advertising Regulation -  Annual Report September 2007 – August 2008 (143Kb)
Maintaining High Standards in Medicines Advertising Regulation - Annual Report September 2006 - August 2007 (156Kb)
Promoting High Standards in Medicines Advertising Regulation - Annual Report September 2005 - 2006 (302Kb)

The regulatory framework

The MHRA works with other statutory regulators and self-regulatory bodies to ensure advertising is fully compliant with EC and UK medicines law. These include:

• Advertising Standards Authority (general advertising).
• Proprietary Association of Great Britain (over the counter medicines).
• Prescription Medicines Code of Practice Authority (prescription medicines).

A Memorandum of Understanding (67Kb) setting out the arrangements for the regulation of the promotion of medicines for prescribing has been agreed between the MHRA, the Prescription Medicines Code of Practice Authority (PMCPA) and the Association of the British Pharmaceutical Industry (ABPI):

The Medicines Advertising Liaison Group (MALG) is a forum consisting of bodies involved in the regulation of medicines advertising that meets about twice a year to discuss current issues in advertising control. The group includes representatives from the Advertising Association, Advertising Standards Authority, Broadcast Advertising Clearance Centre, Committee of Advertising Practice, Proprietary Association of Great Britain, Prescription Medicines Code of Practice Authority, Radio Advertising Clearance Centre, the Health Food Manufacturer’s Association, the British Herbal Medicine Association and the MHRA.

Minutes of the meetings of MALG

Medicines Advisory Liaison Group (MALG) minutes - 23 November 2011 (54Kb)
Medicines Advisory Liaison Group (MALG) minutes - 9 June 2011 (54Kb)
Medicines Advisory Liaison Group (MALG) minutes - 6 October 2010 (68Kb)
Medicines Advisory Liaison Group (MALG) minutes -19 April 2010 (56Kb)
Medicines Advisory Liaison Group (MALG) minutes - 19 October 2009 (50Kb)
Medicines Advisory Liaison Group (MALG) minutes - 30 April 2009 (37Kb)
Medicines Advisory Liaison Group (MALG) minutes - 28 October 2008 (421Kb)
Medicines Advisory Liaison Group (MALG) minutes - 10 April 2008 (403Kb)
Medicines Advisory Liaison Group (MALG) minutes - 2 October 2007 (46Kb)
Medicines Advisory Liaison Group (MALG) minutes - 29 March 2007 (55Kb)
Medicines Advisory Liaison Group (MALG) minutes - 20 September 2006 (48Kb)
Medicines Advisory Liaison Group (MALG) minutes - 24 January 2006 (56Kb)
Medicines Advisory Liaison Group (MALG) minutes - 21 July 2005 (40Kb)
Medicines Advisory Liaison Group (MALG) minutes - 21 January 2005 (18Kb)

Vetting of advertising material

The Regulations allow the MHRA to require sight of advertising before it is issued.

Circumstances where vetting may be required include:

• where a newly licensed product subject to intensive monitoring, is placed on the market; 
• where a product is reclassified product, such as from prescription only (POM) to pharmacy (P); or
• where previous advertising for a product has breached the Regulations.

Within the first criterion above and as a matter of policy, the MHRA has committed to vet initial advertising for all new active substances. This implements recommendations by the Health Select Committee in its report, “The Influence of the Pharmaceutical Industry" (external link).

Further details on vetting are provided in MAIL 152 November/December 2005 and the accompanying press release:
MAIL 152 (83Kb)
Press release: UK health watchdog to vet advertising materials on new medicines

If you would like to enquire about whether we wish to vet advertising materials for a particular product, please email us at advertising@mhra.gsi.gov.uk.

The following leaflet provides advice for companies submitting material for vetting.
Tips for vetting of promotional material (31Kb)

Companies may request a meeting with the MHRA to discuss issues that arise during the vetting procedure.  Further information on scientific advice meetings and a request form are available below:
Scientific advice for licence applicants

Monthly performance on vetting of advertising

Details of the monthly percentage of advertising pieces submitted for vetting where the MHRA provided a response to the company within the target response time of 5 working days are available below:

Monthly performance on vetting of advertising (13Kb)

Complaints procedure

Complaints about medicines advertising may be made in writing to the MHRA Advertising Unit, enclosing where possible a copy of the advertisement or promotional material to the MHRA, Advertising Unit, 14-149 Market Towers, Vauxhall, London, SW8 5NQ .  Alternatively, complete the online complaints form below.  Complaints may also be made to the relevant self-regulatory body.

The Agency acknowledges receipt of all complaints and will contact the advertiser concerned to investigate the case. Full details of how the MHRA investigates complaints and the actions that may be taken are provided in Chapter 7 of the 'Blue Guide' (206Kb)

The fact sheet provides details on how we handle complaints about medicines advertising.

Fact sheet for advertising complaints (24Kb)

During correspondence with the advertiser the identity of the complainant will remain anonymous.

We will endeavour to complete the investigation within 30 calendar days. This time may be extended where there is detailed discussion between the Agency and the company, or when statutory action is taken.  When closing the case the Agency will provide the complainant with details of the outcome and a summary report that will then be published on our website. 

A brief summary on the outcome of each complaint investigated is published in the following section of the website:
› Advertising complaints investigations

Independent Review Panel for Advertising

The Regulations allow a procedure for review of a preliminary opinion of the MHRA that an advertisement for a medicine might be in breach of the Advertising Regulations. The aim of this Independent Review Panel (IRP) is to ensure fairness and openness in the MHRA, with regards to decisions made on advertising.

Companies will have the opportunity to make written representations to the Panel. The MHRA expects that the majority of concerns over advertising will continue to be resolved by informal negotiations with the companies concerned. The statutory right to a review of preliminary decisions together with the establishment of the Independent Review Panel for Advertising to advise Ministers, provides companies with an additional means of having a preliminary decision of their advertising material reconsidered before a final decision is taken by Ministers. The right to seek judicial review of an executive decision on advertising remains.

Specific guidance for companies on how to make representations  to an Independent Review Panel, has been published by the MHRA:

Guidance on the review of advertising by the Independent Review Panel (30Kb)

Further details of the procedure can also be found in the following section of the MHRA website:

Independent Review Panel for Advertising

MHRA guidance notes

In addition to regular featured updates in 'MAIL', the Advertising Unit has compiled the following guidance:

Draft Guidance on Advertising Homeopathic Medicines (128Kb)

The MHRA has worked closely with professional and industry stakeholders to develop specific guidance for advertisers of homeopathic medicines. This is designed to provide clarity about the rules governing the advertising of homeopathic medicines licensed under the three regulatory schemes available. Advertisers of homeopathic medicines are encouraged to review their advertising to ensure that all materials comply with the new guidance. We are also inviting feedback from companies on practical issues raised by implementation.

Comments may be sent to advertising@mhra.gsi.gov.uk. These will be taken into account in finalising the guidance at the end of the year.

Reporting to the public on medicines: advice for journalists and patient organisations (58Kb)

Best practice guidance on the sale of medicines for pain relief (22Kb)

The guidance outlines that no more than two packs should be sold in one transaction and discourages retailers from promoting offers that encourage the sale of more than one pack at a time. These guidelines are the result of the MHRA working with stakeholders who represent both large and small retailers, pharmacists, trading standards offices and the pharmaceutical industry.

Registered Traditional Herbal Medicines: Guidance on Consumer Advertising (77Kb) 

MHRA Guidance Note 23, 'The Blue Guide: Advertising and Promotion of Medicines in the UK' (206Kb). This publication is available to download here as a pdf or from The Stationery Office (external link), price £16.50.

MHRA Guidance Note 24, 'Medicines which are promoted for use during pregnancy: Guidance for the pharmaceutical industry' (113Kb), has been developed for advertisers to ensure safe and responsible advertising of medicines which are promoted for use during pregnancy. The guidance covers advertising for medicines both to the public and to health professionals and supplements the regulatory framework set out in legislation.

MHRA Guidance Note 26, 'Disease Awareness Campaigns (DACs) guidelines' (192Kb)  - Supplementary guidance has been developed by the Agency to help ensure that information provided by pharmaceutical companies and others on health and disease does not fall within the advertising legislation by promoting medicinal products to the public, and to promote good practice.

Website advertising guidance (48Kb) - updated in September 2011.
Advertising of medicines: Updated guidance for consumer websites offering medicinal treatment services The MHRA Advertising Standards Unit has updated this guidance note to provide additional information about the regulatory functions of the MHRA and other bodies which have a role in regulating medicinal treatment services and/or their advertising. The guidance on the content of websites has not changed.

The MHRA has worked closely with health professionals, advertising regulators, patient groups and industry to develop guidance for advertisers on medicines in all the deregulated categories. This guidance, 'Advertising of OTC medicines for formerly restricted therapeutic indications - Best Practice Guidance for the Pharmaceutical Industry', has been published by the Proprietary Association of Great Britain (PAGB) and is available on the Proprietary Association of Great Britain (PAGB) website (external link).


Advertising issues
To supplement the guidance above, the Advertising Unit regularly publishes guidance on good practice to advertisers on topical issues and to clarify policy in areas of concern in 'MAIL', the MHRA's updating journal for medicines. Copies of articles on medicines advertising issues published in 'MAIL' are available below:

Advertising medicines: survey of vetting in 2006 - MAIL 160 March/April 2007

Advertising medicines: publication of statistics on prior vetting - MAIL 159 January/February 2007

Vetting advertising for new active substances - MAIL 152 November/December 2005

Announcing the availability of a new medicinal product – MAIL 151 September/October 2005 (289Kb)

Advertising: Presentation of clinical data – MAIL 148 March/April 2005 (172Kb)

The new Blue Guide: advertising and promotion of medicines in the UK – MAIL 148 March/April 2005 (172Kb)

Advertising: Naming of competitor company in outcome reports of complaints investigated - MAIL 146 November/December 2004 (132Kb)

Advertising: corrective statements - MAIL 146 November/December 2004 (132Kb)

How we investigate complaints – MAIL 145 September /October 2004 (172Kb)

Advertising to the public: Linked medicines - MAIL 144 July/August 2004 (150Kb)

Scientific Advice Meetings - MAIL 144 July/August 2004 (150Kb)

Advertising medicines: Prescribing information - MAIL 143 May/June 2004 (140Kb)

Advertising medicines: As safe as placebo? - MAIL 142 March /April 2004 (237Kb)

Advertising: multi-buy offers - MAIL 142 March/April 2004 (237Kb)

"Fast-acting" and “24 hour” relief claims - MAIL 141 January /February 2004 (143Kb)

Advertising: Reports of completed investigations to be published – MAIL 140 November/December 2003 (542Kb)

Medicines which are promoted for use during pregnancy – publication guidance -  MAIL 135 January/February 2003 (570Kb)

Advertising: The work of the unit - MAIL 130 March/April 2002 (2441Kb)

Contact for further information

Further advice on the advertising of medicines can be obtained from The Advertising Unit, 151 Buckingham Palace Road Victoria London, SW1W 9SZ, email advertising@mhra.gsi.gov.uk