Project to consolidate and review UK medicines legislation

The MHRA is currently undertaking a project to consolidate and review UK medicines legislation.

The current body of UK medicines legislation comprises the Medicines Act 1968 and approximately 200 statutory instruments. It has developed piecemeal since the Medicines Act 1968 came into force some 40 years ago and is fragmented, complex and often difficult to follow.

The project will bring the existing legislation into one set of regulations, and simplify and clarify the way provisions are drafted. It will also identify proposals for substantive policy changes to the current regulatory framework (where there is flexibility to do so under EU legislation) to ensure the legislative framework remains fit for purpose. Our current timetable is for the consolidated legislation to come into force in July 2012.

We have previously published a number of consultations to help us develop the draft regulations and proposals for formal consultation:

• In January 2009, we published a concept paper seeking views on possible areas where reform could be made .– a copy of this paper and a summary of responses can be found on the MHRA website - Concept paper on MHRA project to consolidate and review medicines legislation.
• In August 2010, we published an early, working draft of the consolidated regulations (1869Kb) and a table of origins referencing the existing legislation (166Kb). This draft was published in order to provide an update on what the consolidation phase of the project had achieved to date (for the most part it did not include changes from the review phase) and to obtain informal views and comments from interested parties.
• In October 2010 we published an informal consultation on patient group directions.
• Also in October 2010, we published an informal consultation on exemptions for sale, supply and administration of medicines.
• As part of the project, we are working to reflect the government’s aim of cutting the amount of existing regulation and reducing related paperwork and wider regulatory costs on business. To this end, we published in November 2010 a further informal consultation (75Kb) outlining opportunities that we have identified so far to reduce regulatory burdens through the project and seeking further suggestions from interested parties.
• In February 2011, we published an informal consultation on issues relating to the product licences of right (PLR) regime and homeopathy.