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    Information on nitrosamines for marketing authorisation holders: deadline extended to 1 October 2020

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    The European medicines regulatory network has agreed to extend the deadline to complete step 1 (risk evaluation) to 1 October 2020.

    This follows reports of the challenges encountered in meeting the original deadline of 26 March 2020, and the impact of the severe restrictions in place to combat the COVID-19 pandemic.

    The marketing authorisation holders are encouraged to submit the outcome of step 1 before 1 October 2020 if they complete the risk evaluation or identify a risk in their products.

    Marketing authorisation holders should inform the State Agency of Medicines as soon as possible if tests confirm the presence of nitrosamine, irrespective of the amount detected. They should also assess the immediate risk to patients and take appropriate action to avoid or minimise the exposure of patients to nitrosamines.

    For further information: EMA or HMA webpage

    In case of nitrosamine related questions please contact: nitrosamines@ravimiamet.ee