This is in accordance with the CHMP opinion under Art. 5(3) referral on nitrosamines.
MAHs are obliged to submit the conclusions of the risk evaluations for all of their products. The deadline for submission of the risk evaluation has been postponed to March 31st 2021, please see EMA's website on Nitrosamine impurities for more information.
Medicinal products for human use containing chemically synthesised active product ingredients substances are concerned by this decision. The risk assessments should be performed in line with the guidance given in the following documents:
For medicinal products authorised in Norway via NP, MRP or DCP, marketing authorisation holders should submit the outcome of their risk evaluation via the applicable web form below.
Two templates for reporting the risk evaluation has been prepared by CMDh and EMA:
If risk is identified the following sheet should be filled;
For product authorised via MRP, DCP and NP
For products authorised in Norway we ask that MAHs submit the outcome of the risk evaluation 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.
For products authorised via CP
The risk evaluation for centrally authorised product should be reported directly to EMA. Please see information on EMAs webpage.