Holders of marketing authorisations are responsible for on-going monitoring of the safety of the medicinal products they place on the market. Additionally, the safety profile of all medicinal products is continually reviewed by the Medicines and Healthcare products Regulatory Agency (MHRA) to determine whether there are new risks, if risks have changed, and if any additional risk minimising measures or other regulatory action is required.
Since 2012 it has been a legal requirement for both marketing authorisation holders and medicines regulators to monitor the effectiveness of all such risk minimising measures to determine whether they have had the desired effect. Depending on the findings, further action to minimise risk may be taken.
Recent reviews of the impact of regulatory interventions have been conducted by the MHRA and across the European regulatory network, and further evaluation of the effectiveness of the regulatory regimen in the European Union is ongoing.