Press release: Medicines legislation to be reviewed and consolidated by regulator

Press release

Date:	24 Jul 2008
Time:	09:00
Subject:	MHRA project to review and consolidate medicines legislation
Contact:	Press Office 020 7084 3651 or press.office@mhra.gsi.gov.uk Out-of-hours 07770 446 189

The Medicines and Healthcare products Regulatory Agency (MHRA) will be conducting a project to review and consolidate the current medicines legislation.

There is a growing number of Statutory Instruments (SIs) affecting medicines legislation; a number of which have numerous additional amending SIs. This makes the current legislation unwieldy. The aim of this project is to ensure that the Agency can feel confident that the legislation under which it undertakes its regulatory functions is comprehensive, supportive of its responsibilities and objectives, and is as comprehensible as possible.

The Medicines Act dates from 1968 and since then there have been a growing number of amendments or expansions of the legislation which governs medicines for human use in the UK. The legislation relates to the governance of medicines approved nationally as well as amendments arising from EU legislation. The result is a very complex and fragmented set of legal provisions.

The intention is to bring together the various provisions into a more ordered set, and also seek opportunities to make improvements and to simplify the provisions where possible.

Given the size of the task and the nearly 40 years’ worth of legislation, the project will take approximately two to three years to complete and further updates will be provided during the project. We plan to undertake an informal consultation with industry and external stakeholders in autumn 2008. The purpose of the informal consultation will be to seek input from them on potential areas for reform. This exercise will assist us in accurately defining the scope of the project.

Notes to Editor

1. Medicines control is not an excepted or reserved matter as far as Northern Ireland is concerned. The MHRA will therefore be working closely with colleagues in Northern Ireland to ensure a consistency and continuity of approach.
2. The informal consultation will begin in the autumn and will be open to stakeholder to comment. www.mhra.gov.uk
3. The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone – the public and healthcare professionals as well as the industry – to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action. www.mhra.gov.uk