Riskevaluation Nitrosamins: Extention of Deadline to complete Step 1 to 1 October 2020
messages in brief
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26/03/2020
Information for marketing authorisation holders: Request to evaluate the risk of the presence of nitrosamine impurities in human medicinal products containing chemically synthesised active pharmaceutical ingredients – extention for step 1 risk evaluation to 1 October 2020.
Based on the current situation it has been agreed between the EMA and NCAs to extent the deadline for submission to complete Step 1 for the evaluation of the risk of the presence of nitrosamine impurities in human medicinal products containing chemically synthesised active pharmaceutical ingredients, from 26 March 2020 to 1 October 2020.
https://www.basg.gv.at/en/companies/medicinal-products/quality-of-medicines
Further inquiry note
Page last modified:
26/03/2020