Pharmaceutical companies must continuously monitor and report side effects (also called adverse reactions) from the medicines that they bring onto the market.
Pharmaceutical companies report side effects via:
All side effects are reported to EudraVigilance
All adverse reaction reports (ADR reports) between pharmaceutical companies and the EU drug regulatory authorities is via EudraVigilance, which is a common European database that contains information about side effects in people and animals and also those occurring in clinical trials.
Follow-up questions about ADR reports
When a healthcare professional or a citizen has reported a side effect from a medicine to the Danish Health and Medicines Authority, the holder of the marketing authorisation can pose follow-up questions to the report via the Danish Health and Medicines Authority, which subsequently contacts the reporting party.
Prints of reported adverse drug reactions for download
Information about adverse reaction reports from healthcare professionals, patients and relatives is available here on the website in the form of Prints of reported adverse drug reactions. The listings are called Drug Analysis Prints (DAPs)
The DAPs, or simply the prints, contain all the suspected adverse drug reactions that have been reported in Denmark since 2007.
All reports mentioned in the prints have been communicated to the pharmaceutical companies. Therefore, the Danish Health and Medicines Authority does not expect the pharmaceutical companies to evaluate the prints in relation to the companies' own data.