UK medicines legislation 14/3/03. By Deirdre Janson-Smith All medicines and medical devices must receive a licence (or conditional exemption) from the Healthcare Products Regulatory Agency before they can be released onto the market.

In the UK, all medicines and medical devices for human and animal use are subject to a system of licensing laid down in EC legislation, the UK Medicines Act 1968 and other subsequent legislation.

Two executive agencies were charged with overseeing and enforcing the legislation: the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA), both within the Department of Health. In April 2003, these agencies merged to become the Medicines and Healthcare Products Regulatory Agency (MHRA). The Veterinary Products Directorate (VPD) within DEFRA oversees all veterinary medicines and medical devices.

These executive agencies are served by several independent advisory bodies and appeal boards, also set up under the Act. Two further bodies involved in overseeing the production and use of medicines are the National Institute for Biological Standards and Control (NIBSC), and the National Institute for Clinical Excellence (NICE).

What does MHRA do?

The MHRA is charged with ensuring that all medicines are safe, of good quality and that they benefit the user. It does so by licensing and monitoring medicines and medical devices, checking standards of manufacture and establishing quality standards for drugs.

The Authority is also required to monitor the safety of licensed medicinal products and to take action when adverse effects are recognised (usually reported via the Yellow Card system). It also monitors clinical trials and regulates claims made in advertising and other promotion. As European legislation now takes precedence over UK legislation, the MHRA works within the EU to negotiate and then implement and enforce European Directives.

The MHRA cannot refuse to grant, revoke, vary or suspend a license (except in an emergency) without first consulting the appropriate independent advisory body set up under the terms of the Act.

Main bodies

• The Medicines Commission is the main statutory advisory body set up under the Act. It advises on broad issue of policy relating to the Act and European Directives, and also deals with appeals against MHRA judgements.
• The Committee for Safety of Medicines (CSM) advises whether new products (new active substances) should be granted a marketing authorisation. It monitors the safety of marketed medicines, especially through the Yellow Card system (a rapid alert system for doctors, dentists, pharmacists and manufacturers to register adverse reactions to a product).
• The Advisory Board on the Registration of Homoeopathic Products (ABRHP) gives advice on any homoeopathic medicinal product for human or animal use.
• The Independent Review Panel on Borderline Products (IRPBP) advises on whether borderline products (such as cosmetics or food supplements that claim to protect against or fight disease) require a license. It acts as an appeal body for manufacturers.
• Independent Review Panel on Advertising advises on advertising and other promotional issues, and acts as an appeal board on MHRA rulings.
• The British Pharmacopoeia Commission publishes regular updates of the British Pharmacopoeia, which establishes the quality standards for drugs.

NB: the Veterinary Products Committee plays a wide-ranging advisory role within DEFRA for all veterinary products.

Image credit: Matthew Herring