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Is the Local Medical Literature Search in Pharmacovigilance really an obligation?

Is the Local Medical Literature Search in Pharmacovigilance really an obligation?

  • January 19, 2022

It is well known that the medical literature is a significant source of information for the monitoring of the safety profile and of the risk-benefit balance of medicinal products. However, we may have doubts about whether it is really mandatory or not.

And indeed, yes, it is an obligation. The European Medicines Agency confirms this in the Good Pharmacovigilance Practices (GVP) Module VI:

“The marketing authorisation holder should ensure that the literature review includes the use of reference databases that contain the largest reference of articles in relation to the medicinal product properties.”

“In addition, marketing authorisation holders should have procedures in place to monitor scientific and medical publications in local journals in countries where medicinal products have a marketing authorisation, and to bring them to the attention of the company safety department as appropriate.”

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