The general information on a possible presence of azido impurities was made public in April 2021. Since then, various measures were taken to ensure that any active substance containing these impurities above the acceptable level would not be released onto the market. Additionally, CEP-holders were requested to take corrective action.
While investigating, another azido impurty was identified. In the absence of additional information from in vivo studies, the EDQM emphasises on the necessity to ensure that this mutagenic azido impurity is controlled at or below the Threshold of Toxicological Concern (TTC). The sources impacted by this azido issue have been identified and the EDQM’s review of any necessary corrective action taken by companies is currently either complete or well advanced.
The EDQM reminds all CEP holders of their obligation to provide appropriate information relating to azido impurities to marketing authorisation holders, thus enabling them to use this information to fulfil their legal responsibilities.
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