UK Revamps Drug Regulations

Posted 16 August 2012 | By

A new piece of UK legislation that replaces most of the Medicines Act of 1968 and more than 200 statutory instruments has come into effect, regulators announced this week.

The 14 August passage of the Human Medicines Regulations of 2012 was lauded in a statement released by Medicines and Healthcare product Regulatory Agency (MHRA) officials as reducing clutter and complications that had come to be associated with the law.

The new regulatory scheme 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:

  • Removal of statutory warnings for over-the-counter products, other than paracetamol (acetaminophen) (more information: Labels, patient information leaflets and packaging for medicines)
  • Enabling former members of medicines advisory bodies to be appointed to review panels for MHRA licensing decisions, providing that one year has elapsed since their term of office expired (more information: Dealing with disputes over regulation of medicines)
  • Changes to exemptions that allow health professionals and others to sell, supply and/or administer medicines to reflect modern clinical practice
  • Allowing a pharmacist to make changes to a prescription relating to the name of the product or its common name; directions for use of the product; and precautions relating to the use of the product without having to contact the prescriber before making the change
  • Repeal of permission for pharmacists to wholesale medicines without a wholesale dealer's license.

Commenting on the new scheme, Professor Sir Kent Woods, chief executive of MHRA, said the regulations, "Will simplify 40 years of legislation, much of which has become outdated and fragmented."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," continued Woods.

Chief Executive of the Association of the British Pharmaceutical Industry (ABPI) Stephen Whitehead commented that the ABPI had provided significant input into the process and it is "confident that the interpretation of the consolidated UK legislation will be much clearer going forward."

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