Nitrosamines in medicinal products: report results of risk assessments for impurities

Heard from FAMHP

April 6, 2020

Update 30.03.2020: the deadline for the first part of the risk assessment has been prolonged from 26th March 2020 to the 1st of Octobre 2020.

Early October 2019, the European Medicines Agency (EMA), together with the European medicines authorities, including the FAMHP, asked marketing authorisation holders to perform a risk assessment on the presence of nitrosamines as a precaution. The results of these risk assessments can now be reported.

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