The Human Medicines Regulations 2012 revoke most of the existing legislation within the UK that concern the authorisation, sale, and supply of medicinal products for human use. The Medicines and Healthcare products Regulatory Agency (MHRA) has identified policy changes aimed at ensuring the regulatory framework for medicines remains effective.
These regulations remove an existing exemption from wholesale regarding licensing requirements to ensure compliance with EU law. They also implement an EU Directive 2001/83/EC by introducing the process of ' pharmacovigilance' which monitors the safety of medicines in clinical use and takes appropriate action to minimise potential risks.
