Medicines: marketing authorisation holders submission of Nitrosamine risk evaluation

MAHs should review their manufacturing processes to identify and, if found, to mitigate risk of presence of nitrosamine impurities.  The deadline for provision of the step 1 responses has been extended for an additional 6 months to 1 October 2020.

This deadline is subject to review in light of the ongoing Coronavirus (COVID-19) outbreak and any further changes will be communicated in due course.

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