20.08.2020
To the attention of marketing authorisation holders
As part of the EU-wide measures following the outcome of the assessment carried out by the EMA Committee for Medicinal Products for Human Use (CHMP) in accordance with the requirements of Art. 5(3) (the legal basis for the so-called “referral procedure”), the process for risk assessment of the presence of nitrosamine impurities in all medicinal products for human use containing active substances obtained by chemical synthesis has been ongoing since September 2019.
In this context, in July 2020, the request for risk assessment of the presence of nitrosamine impurities was extended to medicinal products containing biological active substances.
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