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EMA - Medical literature monitoring

The European Medicines Agency (EMA) is responsible for monitoring a number of substances and selected medical literature, to help identify suspected adverse reactions to medicines authorised in the European Union (EU). EMA also enters relevant information into the EudraVigilance database.

The medical literature is an important source of information for the identification of suspected adverse reactions to authorised medicines.

Marketing authorisation holders of medicines in the European Economic Area (EEA) are usually responsible for monitoring the medical literature on their medicines, and reporting individual cases of suspected adverse reactions into EudraVigilance and national safety databases. This is in line with PDF iconModule VI of good pharmacovigilance practices (GVP).

However, for a number of substances with many marketing authorisations and multiple marketing authorisation holders in the EEA, EMA provides a medical literature monitoring service. This service aims to:

The service has been fully operational since September 2015. The legal basis is Article 27 of Regulation (EC) No 726/2004.

Marketing authorisation holders are usually responsible for monitoring the medical literature on their medicines, and reporting individual cases of suspected adverse reactions into EudraVigilance and national safety databases.

However, they are not required to monitor or report suspected adverse reactions from the medical literature EMA monitors to EudraVigilance for active substances covered by EMA's service.

EMA makes the individual cases of suspected adverse reactions it finds in the literature available to marketing authorisation holders, so that they can include them in their safety databases and meet their reporting obligations outside the EEA.

Marketing authorisation holders should note that they are required to monitor and report to EudraVigilance suspected adverse reactions:

  • recorded in all medical literature for active substances that are not covered by the service;
  • recorded in medical literature that EMA does not monitor as part of its service, including for active substances that are covered by EMA's service.

 

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