Reminder: EMA advises companies on steps to take to avoid nitrosamines in human medicines

News Category: Regulatory news

Date: 03/12/2019

As first highlighted in late September 2019, the EMA’s human medicines committee (CHMP) is requesting as a matter of precaution that marketing authorisation holders for human medicines containing chemically synthesised active substances review their medicines for the possible presence of nitrosamines and test all products at risk.

Although nitrosamines are not expected to form during the manufacture of the vast majority of medicines containing chemically synthesised active substances, it is important that all companies who have not already done so take appropriate precautionary measures, if necessary, in line with recommendations from the recently concluded review of sartans.

Further information for companies in respect of centrally authorised medicines is available from the EMA website. Information on non-centrally authorised medicines can be found on the CMDh website.

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