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.
There are only a few changes introduced by the Regulations:
- removal of statutory warnings for over the counter products other than paracetamol
- 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
- changing exemptions relating to the supply of medicines by healthcare professionals to reflect modern practice
- updating the process for the use of patient group directions
- 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
- 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.