Medicines and Healthcare products Regulatory Agency (MHRA) has just released the Blue Guide on advertising and promotion of medicines in the UK. It introduces controls on medicines advertising in the UK and provides background information on the development of Blue Guide.

There is a specific licensing system for medicines, operated in the UK by the MHRA. Its work is underpinned by robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. Its licensing schemes cover the whole range of medicines for human use, from registration for herbal and homoeopathic remedies to marketing authorization for the latest innovative advanced technology medicinal products. This guide uses the general term ‘licence’ to refer to all these schemes.

The MHRA also contributes to the work of licensing medicines in the European Union (EU), co-ordinated by the European Medicines Agency (EMA). The EMA operates a centralized procedure for the scientific review of applications for innovative medicines, leading to a marketing authorization from the European Commission that is valid across the EU.

The basis of the licence for any medicine is the Summary of Product Characteristics (SPC). This sets out the details of what the product is licensed for, how it should be administered and warnings and side effects. The SPC sets the boundaries for what can be claimed in advertising for the product.

The licence also determines how the product may be supplied. This may be on prescription only or non-prescription, either through pharmacies under the supervision of a pharmacist or on general sale which in turn determines to whom the product may be advertised.

Advertising of medicines is acceptable provided it is in line with legislation and agreed standards of good practice. Society demands that advertising of any commodity, service or anything that may be of interest to the consumer, should be of a high standard. It should not include anything that could cause serious additional specific legislation that applies to the advertising of medicines. All advertising and promotion of medicines, both for self-medication and to healthcare professionals where medical prescription is required, must be responsible and of the highest standard, said the regulatory authority.

Further all means and media used in the promotional marketing of medicines are subject to the legislation controlling advertising. This includes evolving digital communications channels as well as more conventional communications.

Medicines advertising in the UK is regulated by a combination of European and national legislation.

In addition, it lays down the requirements and restrictions for advertising, aimed at either prescribers or suppliers of medicines to the public, or at the public as purchasers of over-the-counter medicines. Central to this is the principle that advertising of prescription only medicines to the public is prohibited. The decision to prescribe a certain medicine is taken by a qualified healthcare professional on the basis of informed discussion with the patient.

The control of medicines advertising in the UK is based on a long established system of self-regulation supported by the statutory role of the MHRA, acting on behalf of Health Ministers. Self-regulation is permitted under European law covering medicines advertising.

The MHRA has a clearly defined role and acts on behalf of Health Ministers to protect public health by promoting the safe use of medicines. In seeking to ensure advertising is fully compliant with UK and European medicines law, the MHRA works closely with other statutory regulators and self-regulatory bodies to ensure a consistent approach so that public health and safety is not compromised in any way.