Question 3 refers to the submission templates for Step 2 "Confirmatory testing".
The template "Step 2 - Nitrosamines detected above acceptable intake or new nitrosamine detected response template" should only be used in addition to the "Step 2 -Nitrosamines detected response template" if
Important deadlines for MAHs to submit their confirmatory tests under step 2:
Question 10 newly lists N-nitrosomorpholine, NMOR with a limit of 127 ng/g .
Source:
EMA: Nitrosamine impurities
EMA: Q&A
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