Information on nitrosamines for marketing authorisation holders - Updated questions and answers document published by EMA

News Category: Regulatory news

Date: 20/12/2019

As announced 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.

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.

Please note that a revised version of the EMA document Questions and answers on “Information on nitrosamines for marketing authorisation holders” with new and updated information, has now been published (dated 20 December 2019). This questions and answers document should be read in conjunction with the document Information on nitrosamines for marketing authorisation holders.

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