The Danish Medicines Agency monitors adverse reactions

During the first two years of a medicinal product's life on the market, adverse reactions are monitored closely.

Doctors must report adverse reactions

Doctors have an obligation to report all adverse reactions from a medicinal product during the first two years of a product's life on the market. After that, any serious and unexpected adverse reactions must be reported.

The pharmaceutical companies must report adverse reactions

The pharmaceutical companies have an obligation to submit safety updates every six months describing the safety of a product. The report must at least include:

•  a list of the adverse reactions known to the company
• an estimate of the number of patients treated with the medicinal product
• an overall assessment of the medicinal product's safety profile
• suggestions for new initiatives as regards safety, if relevant.

Patients can report adverse reactions

Patients and relatives can report adverse reactions directly to the Danish Medicines Agency.

Report adverse reactions in the factbox to the right.