Companies' reporting of side effects

Updated 23 November 2017

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

Electronic exchange of adverse reaction reports

The EMA launched the upgraded version of the European pharmacovigilance database, the EudraVigilance database, on 22 November 2017. This implies a number of changes for pharmaceutical companies that exchange adverse reaction reports with the Danish Medicines Agency.

From 22 November 2017, all marketing authorisation holders of medicinal products for human use must report all suspected adverse reactions to the EudraVigilance database. The Danish Medicines Agency has access to the reports in the EudraVigilance database.

As from 22 November 2017, the Danish Medicines Agency will no longer receive adverse reaction reports directly from marketing authorisation holders (MAH), and we will not be able to send adverse reaction reports directly to the MAH. It is 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 adverse reactions by citizens and healthcare professionals to the Danish Medicines Agency will not be changed. 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.

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.

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

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

Origin

Serious/non-serious

Time frame

EU/EEA

All serious

15 days

EU/EEA

All non-serious

90 days

Outside the EU/EEA (third countries)

All serious

15 days

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