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This page provides information on the Human Medicines Regulations 2012 (SI 2012/1916), which came into force on 14 August 2012.
The Regulations set out a comprehensive regime for the authorisation of medicinal products for human use; for the manufacture, import, distribution, sale and supply of those products; for their labelling and advertising; and for pharmacovigilance.
For the most part the Regulations implement Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the community code relating to medicinal products for human use (as amended). They also provide for the enforcement in the United Kingdom of Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.
The Regulations, along with an explanatory memorandum and impact assessments, are available to download here:
Human Medicines Regulations 2012 (SI 2012/1916) (external link)
Consolidation of UK medicines legislation
The regulations are the result of the MHRA’s consolidation and review of UK medicines legislation. They replace nearly all UK medicines legislation – most of the Medicines Act 1968 and over 200 statutory instruments.
The following resources are intended to explain this exercise and assist with the transition to the new legislation:
- more information on how we undertook the consolidation and review of UK medicines legislation
- a description of each Part of the Regulations (33Kb)
- a ‘table of origins (221Kb)’ showing where provisions in the Regulations originated from
Policy changes introduced by the legislation
The Regulations also introduce the following small policy changes through the Regulations to help ensure that medicines legislation is fit for purpose:
- removal of statutory warnings for over the counter products, other than paracetamol; more information is available here - 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 on any such body has expired; more information is available here - Dealing with disputes over regulation of medicines
- existing medicines legislation allows health professionals and others to sell, supply and/or administer medicines by way of exemptions from the usual restrictions - the Regulations remove a number of obsolete exemptions, amend or extend some current exemptions, and introduce some new exemptions in order to reflect modern clinical practice
- updating the process by which independent hospitals, clinics and agencies are able to continue using patient group directions (PGDs) to ensure processes reflect changes to the registration requirements for organisations
- the Regulations consolidate provisions enabling a pharmacist, if in the exercise of their professional skill and judgement they believe it is appropriate to do so, 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 - the Regulations remove the requirement for the pharmacist to attempt to contact the prescriber before making such change; This aims to enable pharmacists to use their expertise and professional judgement to make such changes in a more timely way
- repeal section 10(7) of the Medicines Act 1968. Section 10(7) 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; more information on this is available here - Supply of medicines by pharmacy to healthcare professionals
Implementation of Directive 2010/84/EU
The Regulations also implement EU Directive 2010/84/EU, which amends Directive 2010/84.EU to introduce a strengthened, clarified and more proportionate regime for pharmacovigilance in the EU market. More information on this is available here: