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.

See full guidence here