Companies' reporting of side effects

Reports of suspected adverse reactions – from marketing authorisation holders of medicinal products for human use

Marketing authorisation holders must continuously monitor and report suspected adverse reactions from the company’s marketed medicinal products.

All holders of a marketing authorisation of a medicinal product for human use must submit suspected adverse reactions directly to the EudraVigilance database.

The Danish Medicines Agency will not receive adverse reaction reports directly from marketing authorisation holders (MAH) and are not able to send adverse reaction reports directly to the MAH. The Danish Medicines Agency has access to the adverse reaction reports through the EudraVigilance database.

The Danish Medicines Agency sends all reports of suspected adverse reactions from authorised medicinal products with a valid marketing authorisation to the EudraVigilance database. Marketing authorisation holders have access to the EudraVigilance database and are obliged to monitor the database regularly.

It is thus important that companies reporting adverse reactions keep updated on the EMA’s website and make sure that processes and IT systems support the new common European processes for direct reporting to the EudraVigilance database.

The rules governing the reporting of serious adverse reactions in connection with clinical trials (SUSARs) remain unchanged. You can find more information on the reporting of SUSARs under Clinical Trials. See this link: Clinical Trials

Below, you can find information about the types of spontaneous reports that should be sent to the EudraVigilance database and the time frames. This applies to all procedures for marketing authorisations.