Information on nitrosamines for Marketing Authorisation Holders before the closing date for the submission
Marketing authorisation holders should review their manufacturing processes forall products containing chemically synthesised or biological active substances to identify and, if necessary, mitigate the risk of presence of nitrosamine impurities according to the outcome of the referral under Article 5(3) of Regulation EC (No) 726/2004.
Conduct a risk evaluation to identify active substances and finished products at risk of N-nitrosamine formation or (cross-)contamination and report the outcome by:
31 March 2021 for chemical medicines;
1 July 2021 for biological medicines.