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August 14, 2012

UK MHRA unveils new simplified medicines regulations

The Medicines and Healthcare products Regulatory Agency (MHRA), UK has introduced simplified regulations for medicine, the Human Medicines Regulations 2012.

The Medicines and Healthcare products Regulatory Agency (MHRA), UK has introduced simplified regulations for medicine, the Human Medicines Regulations 2012.

The new regulations were formulated to consolidate and review UK medicines legislation, and follow extensive consultation with interested parties.

MHRA chief executive Professor Sir Kent Woods said the regulations will simplify 40 years of outdated and fragmented legislation.

"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," Woods said.

The regulations, which replace the Medicines Act 1968 and around 200 statutory instruments, will simplify medicines legislation while upholding effective safeguards for public health.

The simplified regulations introduce small policy changes including the removal of statutory warnings for packaging; improvements to the review hearings process; updating of sale, supply and administration exemptions; updating provisions for patient group directions; and optimisation of medicines use.

The Association of the British Pharmaceutical Industry (ABPI) chief executive Stephen Whitehead said the MHRA has undertaken considerable work to consolidate and update the regulations to ensure they are fit for purpose.

"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," Whitehead said.

The regulations also allow for the implementation of EU legislation on pharmacovigilance (monitoring the safety of medicines), which will enable a clearer, and more uniform approach across Europe.

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