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.
In this section...
Advertising can be presented in several forms, including:
- medical journals
- 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 Human Medicines 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 Part 14 of the Human Medicines Regulations 2012. 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.
The Blue Guide
View an online interactive version of The Blue Guide: Advertising and promotion of medicines in the UK This includes comprehensive guidance on the MHRA’s interpretation of the legal requirements for advertising medicines in the UK and how such advertising is regulated
Alternatively you can access the PDF version here:
The Blue Guide: Advertising and promotion of medicines in the UK (630Kb)
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 2012 (112Kb)
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.
Medicines Advisory Liaison Group (MALG) minutes - 11 June 2013 (83Kb)
Medicines Advisory Liaison Group (MALG) minutes - 21 November 2012 (52Kb)
Medicines Advisory Liaison Group (MALG) minutes - 21 May 2012 (65Kb)
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)
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).
If you would like to enquire about whether we wish to vet advertising materials for a particular product, please email us at firstname.lastname@example.org.
The following leaflet provides advice for companies submitting material for vetting.
Tips for vetting of promotional material (110Kb)
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 five working days are available below:
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 Standards Unit, 151 Buckingham Palace Road Victoria London, SW1W 9SZ, email email@example.com Alternatively, complete the online complaints form. 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 8 of the 'Blue Guide' (49Kb)
The fact sheet provides details on how we handle complaints about medicines advertising.
During correspondence with the advertiser the identity of the complainant will remain confidential. Once a case is resolved, MHRA may disclose the complainant’s company name if they are a competitor. The identity of individual complainants will continue to remain confidential.
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.
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 as Appendix 8 of the Blue Guide (39Kb).
Further details of the procedure can also be found in the following section of the MHRA website:
MHRA guidance notes
The Advertising Standards Unit has compiled the following guidance:
The Third Edition was published in August 2012. This includes comprehensive guidance on the MHRA’s interpretation of the legal requirements for advertising medicines in the UK and how such advertising is regulated.
Specific guides are included as appendices. These are designed to provide detailed advice on the legislation relating to a particular area in an easily accessible form.
Contact for further information
Further advice on the advertising of medicines can be obtained from the Advertising Standards Unit, 151 Buckingham Palace Road Victoria London, SW1W 9SZ, email firstname.lastname@example.org