Nitrosamines in medicinal products: report results of risk assessments for impurities

date: 31/10/2019

Update 30.03.2020: the deadline for the first part of the risk assessment has been prolonged from 26th March 2020 to the 1st of Octobre 2020. 


Early October 2019, the European Medicines Agency (EMA), together with the European medicines authorities, including the FAMHP, asked marketing authorisation holders to perform a risk assessment on the presence of nitrosamines as a precaution. The results of these risk assessments can now be reported.

Risk assessments must take place for all authorised medicinal products for human use containing chemically synthesised active substances, regardless of the authorisation procedure. Previously, EMA published recommendations on which actions should be taken and a questions and answers document.

Report risk assessments for NPs, DCPs and MRPs to the FAMHP online
EMA and the CMDh (Coordination Group for Mutual Recognition and Decentralised Procedures, Human) created templates to report risk assessments to the competent authorities. Send in the information regarding NPs (national procedures), DCPs (decentralised procedures) and MRPs (mutual recognition procedures) using the forms below.

  • There is no risk. Fill in the template and send it in using this web form.
  • There was a risk of nitrosamine presence identified. Fill in the template and the Excel file and send in both using this web form.

Additional step for DCP and MRP
Please note, for DCPs and MRPs, there is an additional step to take. The completed template and the Excel file must also be sent to all affected member states.

The information for CPs needs to be reported directly to EMA.

Results can be reported until 26 March 2020.

Further information
FAMHP News 02.10.2019
CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines


Last updated on 30/03/2020