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UK brings in new medicines regulations

Human Medicines Regulations 2012 aim to simplify existing legislation

New regulations that aim to simplify the UK's existing medicines legislation have come into force this week.

The Human Medicines Regulations 2012 replaces much of the Medicines Act and around 200 statutory instruments and will, the Medicines and Healthcare products Regulatory Agency (MHRA) said, reduce the regulatory burden on business.

Chief executive Professor Sir Kent Woods said: “These regulations will simplify 40 years of legislation, much of which has become outdated and fragmented.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.”

The Human Medicines Regulations 2012 also brings in a series of small policy changes aimed at ensuring 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

• Updating provisions for patient group directions

• The optimisation of medicines use.

Within these changes are provisions allowing pharmacists to “make changes to a prescription relating to the name of the product or its common name” if they believe it is appropriate to do so. They also remove the obligation for pharmacists to try to contact the prescriber before they do so.

“This aims to enable pharmacists to use their expertise and professional judgement to make such changes in a more timely way,” the regulations say.

Other changes contained in the rules will see them implement the new European pharmacovigilance rules, introduced by the European Medicines Agency (EMA) last month.

The introduction of the Human Medicines Regulations 2012 has been backed by the UK pharmaceutical industry.

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.”

• Human Medicines Regulations 2012

16th August 2012


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