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MHRA launches review of legislation

The Medicines and Healthcare products Regulatory Agency in the UK has launched a new project to review and consolidate current medicines legislation
The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has launched a new project to review and consolidate current medicines legislation.

According to the Agency, there are a growing number of statutory instruments (SIs) affecting existing legislation making current law governing medicines hard to manage. SIs are secondary or subordinate legislation normally comprising an order, regulations, rules or a scheme. They are made under powers conferred by primary legislation (an enabling act).

The new project aims to help the MHRA feel confident that the legislation it uses to regulate medicines and healthcare products is comprehensive, and supports its responsibilities and objectives.

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

The Medicines act dates back to 1968 and relates to the governance of medicines approved for human use in the UK. Since its introduction, many amendments have been made to the statute, including additional provisions laid down by EU legislation, resulting in a complex and fragmented set of law.

The review project is expected to take two to three years to complete with further updates being provided throughout the course of the initiative. MHRA plans to hold an informal consultation with industry and external stakeholders in Autumn 2008, so the agency can gain input on potential areas of reform.

24th July 2008

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