The Human Medicines Regulations 2012 have come into force on 14 Augsut 2012. The regulations are the result of the initiative by the Medicines and Healthcare products Regulatory Agency (MHRA) to consolidate and review UK medicines legislation, and follow extensive consultation with interested parties.


The regulations significantly simplify medicines legislation while maintaining strong and effective safeguards for public health. They will also reduce regulatory burden on business. They replace much of the Medicines Act 1968 and around 200 statutory instruments, in the process repealing much obsolete law and contributing to the government’s drive for burden reduction.


They also introduce some small policy changes to help ensure that 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 and of provisions for patient group directions; and optimisation of medicines use.


In addition, the regulations include provisions to implement new EU legislation on pharmacovigilance (monitoring the safety of medicines). These provisions introduce a strengthened, clarified and more proportionate regime for pharmacovigilance to ensure a high level of public health protection across the EU.