|Date:||14 August 2012|
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The Human Medicines Regulations 2012 have come into force today. The regulations are the result of the initiative by the Medicines and Healthcare products Regulatory Agency (MHRA) to consolidate and review UK medicines legislation, and follow extensive consultation with interested parties
The regulations significantly simplify medicines legislation whilst maintaining strong and effective safeguards for public health. They will also reduce regulatory burden on business. They replace much of the Medicines Act 1968 and around 200 statutory instruments, in the process repealing much obsolete law and contributing to the government’s drive for burden reduction.
They also introduce some small policy changes to help ensure that the legislation remains fit for purpose and reflects modern practice. These relate to the removal of statutory warnings for packaging; improvements to the process for review hearings; updating of sale, supply and administration exemptions and of provisions for patient group directions; and optimisation of medicines use.
In addition, the regulations include provisions to implement new EU legislation on pharmacovigilance (monitoring the safety of medicines). These provisions introduce a strengthened, clarified and more proportionate regime for pharmacovigilance to ensure a high level of public health protection across the EU.
Professor Sir Kent Woods, MHRA Chief Executive said: “These regulations will simplify 40 years of legislation, much of which has become outdated and fragmented. They will help ensure that medicines regulation is supported by a modern and straightforward legal framework, and provide a platform for further burden reduction initiatives through the MHRA’s Regulatory Excellence programme.”
Stephen Whitehead, Chief Executive of the Association of the British Pharmaceutical Industry (ABPI) said: “The MHRA has undertaken a significant amount of work to consolidate and update the UK medicines regulations in order to ensure they are fit for purpose for the healthcare sector. The ABPI provided significant input into the process and we are confident that the interpretation of the consolidated UK legislation
will be much clearer going forward.”
Sheila Kelly, Chief Executive of the Proprietary Association of Great Britain (PAGB) said: “The over-the-counter medicines industry very much welcomes the introduction of the Human Medicines Regulations 2012. The consolidated text is much clearer, more user-friendly and will help reduce unnecessary regulatory burden for companies.”
Notes to Editor1. 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 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
2. Our Agency-wide programme of regulatory excellence focuses on the twin aims of simplifying and reducing regulatory burdens where it is safe to do and of ensuring that the new regulatory ideas and proposals are developed in ways that best align with the wider Government's objectives for targeted, proportionate regulation. There will be a strong focus in support of Government strategies to promote life sciences in the UK.
3. Project to consolidate and review UK medicines legislation