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Press release: Medicines consolidation consultation paves the way for regulatory excellence

Press release

Date: 26 October 2011
Time: 10:00
Contact: Press Office 020 3080 7651
or press.office@mhra.gsi.gov.uk
Out-of-hours 07770 446 189

The Medicines and Healthcare products Regulatory Agency (MHRA) yesterday launched a formal public consultation on the consolidation of UK medicines legislation.

Interested parties are encouraged to contribute to the development of the legislation which will greatly simplify and clarify the law regulating medicines in the UK.

The draft consolidated regulations will be presented to test that they are complete, accurate, user-friendly and do not introduce unintended changes. The consultation also proposes policy changes to ensure that medicines legislation remains fit for purpose and reflects modern practice.

MHRA Chief Executive, Sir Kent Woods, said: "Medicines legislation which has been amended many times over several decades can be greatly simplified by consolidation. The current need for this has received widespread support from both pharmacists and the pharmaceutical industry.

“It will amalgamate 40 years’ of outdated and fragmented legislation, reducing it by around two thirds, making it clearer and easier to understand as well as ensuring that medicines regulation is supported by a modern and straightforward legal framework.”

The consolidation is the cornerstone of the MHRA’s Regulatory Excellence programme that will examine regulations to ensure that they remain fit for purpose and that the MHRA continues to deliver high-quality and proportionate regulation to safeguard public health.

The Association of British Pharmaceutical Industry (ABPI) Chief Executive, Stephen Whitehead, said: "The ABPI welcomes this opportunity to contribute to providing clearer legislation and encourages our members to actively participate in the consultation.”

The Proprietary Association of Great Britain (PAGB) Director of Legal and Regulatory Affairs, Helen Darracott, also commented: “The work to consolidate the complex UK medicines legislation is very much welcomed by the over-the-counter medicines industry. We look forward to engaging in the consultation to deliver a more concise and simplified legal text that is clear, meaningful and user-friendly to work with.”

The finalised consolidated legislation is due to come into force in July 2012.

Notes to Editor

  1. The consolidation will replace approximately 200 Statutory Instruments (SIs) relating to human medicines and much of the Medicines Act 1968 with uniform and simplified regulations named The Human Medicines Regulations.
  2. 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.
Page last modified: 26 October 2011