Marketing authorisation holders should review their manufacturing processes for all products containing chemically synthesised or biological active substances to identify and, if necessary, mitigate the risk of presence of nitrosamine impurities.
During step 1, a risk assessment was already reported to the health authorities.
The next step is the confirmatory testing on the products identified to be at risk of N-nitrosamine formation or (cross-)contamination. If tests confirm the presence of nitrosamine, irrespective of the amount detected, the national competent authorities for nationally authorised products or EMA for centrally authorised products should be informed as soon as possible.
CmDH has published an ‘Assessment report template’ for the nitrosamine risk assessment for the outcome of step 2 – “nitrosamine detected”. MAHs should use the templates below in their responses:
- Step 2 – No nitrosamine detected response template
- Step 2 – Nitrosamine detected response template (doc)
- Step 2 – Nitrosamine detected above acceptable intake or new nitrosamine detected response template (xls)
For more information on the response templates to be used, the CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products is available.
For additional specific information related to nationally authorised products, the CMDh has drafted a practical guidance document.