Medicines and Healthcare products Regulatory Agency [MHRA]

Before a medicinal product can be marketed and sold, a marketing authorisation must be obtained from the relevent National Competent Authorities. The marketing authorisation application process can take one of two paths - the decentralised procedure, or the centralised procedure. In some cases in Europe, the centralised procedure is mandatory.

Safety communication is put in place to communicate adverse reactions or any safety findings to regulators, healthcare providers and patients. Safety communications are provided by marketing authorisation holders and health authorities, and may include restrictions, contraindications, dose limitations, warnings, and recommendations.