The risk evaluation process now required as of October 1, 2020, corresponds to Step 1 (Step 1 conduct of risk evaluation) of the three-step process specified by the EMA. The results are reported back to the agency by the marketing authorisation holders using one of the two corresponding templates:
- the "No risk identified response template", confirming that no risk has been identified or
- the "Risk identified response template", confirming that a risk has been identified. In this case, a confirmation/nonconfirmation of a nitrosamine contamination must be sent directly to the EMA under Step 2 (Step 2 Perform further confirmatory testing).
A detailed description of all requirements and access to the templates of steps 1, 2 and 3 can be found here.
In the course of this process, the EMA has updated the 11-page Q&A document for MAHs. The following Q&As have been revised:
- Question 4 deals with the development of analytical methods for the determination of nitrosamines and is mentioned as a supplement for Step 2.
- Question 5 is mentioned as a further source of information for Step 1. It explains in detail how the results of the risk assessments can be submitted.
- Question 6 deals with interim limits. With the substantial number of APIs and finished products involved, final limits of nitrosamines for non-sartan products are still under consideration.
- Question 13 takes up the approach for new and ongoing applications for authorisation.
Click here to view the Q&A document.
Source
EMA: Human Regulatory/Nitrosamine impurities