As a precaution, all marketing authorisation holders are asked to perform a risk evaluation (step 1) to assess the possibility of nitrosamines being present in all of their medicinal products. If risk of nitrosamine presence was identified in step 1, the marketing authorisation holder should perform confirmatory testing (step 2).
This is in accordance with the CHMP opinion under Art. 5(3) referral on nitrosamines.
All medicinal products for human use are concerned by this decision. The risk evaluations and confirmatory testing should be performed in line with the guidance given in the following documents:
For products authorised via MRP, DCP and NP in Norway - Step 1, Risk evaluation
MAHs are obliged to submit the conclusions of the risk evaluations for all of their products. The deadline for submission of the risk evaluation was March 31st 2021 for products containing chemically synthesised APIs and July 1st 2021 for products containing biological APIs, please see EMA's website on Nitrosamine impurities for more information.
For medicinal products authorised in Norway via NP, MRP or DCP, marketing authorisation holders should submit the outcome of their risk evaluation (step 1) via the applicable web form below. The deadline for submission of risk evaluation has passed. However, the web form is still accessible in case new information (e.g. related to a new potential root cause) is identified, then step 1 should be repeated.
Templates for reporting the risk evaluation have been prepared by CMDh and EMA.
For product authorised via MRP, DCP and NP
MAHs are asked to submit the outcome of the risk evaluation (step 1) and the relevant templates via the applicable web form:
Form overview (pdf):
We ask that one web form is submitted for each product. However, several products can be combined in one template given that the outcome is the identical.
Please note that the form is mandatory for all products authorised via MRP, DCP and NP. Outcome of risk evaluation for products authorised in Norway submitted via email will not be considered.
The risk evaluation documents do not need to be submitted, but should be made available upon request.
Please note that the web form for submission of no risk identified outcomes has been updated. It's not necessary to resubmit already submitted outcomes via the updated template.
For products authorised via MRP, DCP and NP in Norway - Step 2, Confirmatory testing
If risk of presence of nitrosamines was identified in the risk evaluation, confirmatory testing should be performed.
For information on how to submit outcome of the confirmatory testing (step 2), please seeCMDh's practical guidance for Marketing Authorisation Holders of nationally authorised products (including MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines.
The results should be submitted as soon as possible. The NoMA does not have any additional requirements for submission of confirmatory testing other than that stated by the CMDh.
For products authorised via CP
The risk evaluation and confirmatory testing for centrally authorised products should be reported directly to EMA. Please see information on EMAs webpage.