Adverse reactions and safety of medicinal cannabis
The Danish Medicines Agency monitors adverse reactions and the safety of medicinal cannabis.
We collect adverse reaction report (ADR reports) to identify any signals of new or changed risks about the pilot programme’s cannabis products, and the ADR reports are part of the basis we use to regularly assess the safety profiles of the products.
We subject the ADR data to scientific evaluation, consider options for risk minimisation and risk prevention, and, if needed, we take appropriate measures in relation to the distribution and dispensing of the products.
Doctors have a duty to report suspected adverse reactions
Doctors are required to report all suspected adverse reactions of cannabis products to the Danish Medicines Agency. Serious adverse reactions must be reported to us no later than 15 days after the doctor became aware of an occurrence.
Other healthcare professionals, patients and relatives have the option of reporting suspected adverse reactions
Other health professionals, patients and relatives have the option of reporting suspected adverse reactions of cannabis products to the Danish Medicines Agency.
To submit a report, please go to the page: