How we monitor the safety of products

The Agency also uses a variety of methods of collecting  information on medicines. Healthcare professionals, as well as patients, are encouraged to report suspected adverse drug reactions and there is a legal requirement for companies to report such reactions to their products to us. A register of these suspected adverse reactions is maintained which helps provide early warnings of potential drug hazards. Our Defective Medicines Report Centre (DMRC) receives and assesses complaints and reports of actual or suspected defects in medicines.

Medical devices are extremely diverse and we use in-house specialist knowledge, comprehensive information systems and access to up-to-date external advice to issue appropriate advice. This may address device or user-related issues, or both. Any adverse incident involving a medical device or instructions for use should be reported to the MHRA.

The process of monitoring the safety of blood and blood components is known as haemovigilance. From 8 November 2005 the EU Blood Safety Directive will require that serious adverse events and serious adverse reactions related to blood and blood components are reported to the MHRA, the UK Competent Authority for blood safety.