Latest News

Regulatory News: MHRA continues to consult on the consolidation of UK medicines legislation

28th November 2011

On October 26, 2011 the MHRA launched further public consultation on the consolidation and review of UK medicines legislation.

The MHRA's aim is to consolidate and review UK medicines legislation, replacing approximately 200 statutory instruments relating to human medicines and much of the Medicines Act 1968. The project will cover all national legislation governing medicines for human use, including homoeopathic and herbal medicines.

The consolidation will result in uniform and simplified regulations named The Human Medicines Regulations due to come into force in July 2012.

The Medicines Act 1968 is more than 40 years old and over the years has undergone a number of amendments and expansions in form of statutory instruments. These amendments and expansions have made it complex and fragmented. In addition, some provisions of the legislation are not in line with current European Union driven regulation of medicinal products.

The MHRA initiated the project with its first consultation in January 2009 seeking views on possible areas where reforms could be made.  This consultation was followed by an early working draft of the consolidated regulations in August 2010.

The recent public consultation launched on October 26, 2011 will be open for 12 weeks; comments are invited by Tuesday 17 January 2012. This consultation invites feedback on the draft consolidated medicines regulations and proposed policy changes to ensure that medicines legislation is current and fit for purpose.

The consolidation of the UK medicines legislation is part of the MHRA’s Regulatory Excellence programme that will examine regulations to ensure that they remain relevant and help in controlling medicines with regards to their quality, safety and efficacy.

Reviewed by Shilpa Jain, Regulatory Affairs Executive