The Human Medicines Regulations 2012 (Regulations) have come into force today.  They are a welcome consolidation of UK medicines legislation.  They consolidate most of the Medicines Act 1968 and 200+ statutory instruments.

The Medicines and Healthcare products Regulatory Authority (MHRA) has produced a Table of Origins as well as a list of the legislation repealed by the Regulations.

There are only a few changes introduced by the Regulations:

  1. removal of statutory warnings for over the counter products other than paracetamol
  2. allowing individuals to be appointed to review panels for MHRA licensing decisions even if they have been a member of a medicines advisory body if at least 12 months has elapsed since their term of office on any such body has expired
  3. changing exemptions relating to the supply of medicines by healthcare professionals to reflect modern practice
  4. updating the process for the use of patient group directions
  5. removing the requirement for the pharmacist to attempt to contact the prescriber before making permitted changes to a prescription such as relating to the name of the product or its common name
  6. repeal of the provision which allows pharmacists to wholesale deal medicines without a wholesale dealer’s licence, where that dealing constitutes no more than an inconsiderable part of that business

together with implementation of the amended EU Directive 2010/84/EU which introduces the new pharmacovigilance regime.