The CMDh agreed on a template for the nitrosamine risk evaluation. This template should be used in marketing authorisation applications to document that the risk evaluation has been performed based on the current scientific knowledge. Applicants are requested to complete the template and to add it to the documentation in Module 3.2.P.5.6. The template supplements the risk evaluation but does not replace a thorough assessment from the applicant. It is expected that by confirming the evaluation with “yes” in the template, it is assured that all risk factors are sufficiently addressed in the risk evaluation itself.
The template can be used immediately but will become mandatory for new DCP MA applications submitted as of 1 July 2022. RMSs may also request the submission of the template for ongoing MA applications, as needed.
The CMDh practical guidance for MAHs of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) referral on nitrosamines has been updated accordingly to reflect the use of the template.
The new template will be published on the CMDh website under “Advice from CMDh > Nitrosamine impurities”.