EMA: Update of Q&As for Nitrosamine Impurities
The EMA has updated its Q&As for marketing authorisation holders and applicants regarding nitrosamine impurities in human medicinal products. This is revision 23.
Q&A 22 has been updated to clarify the timeframe for applying the higher interim limit during CAPA implementation. Question 22 is: What is the approach to control presence of N-nitrosamine exceeding the acceptable intake (AI) during CAPA implementation?
The described approach to accept higher interim limits is applicable to all authorised products that have CAPA implementation timeline of up to 3 years from the date of publication of the initial AI.
The revised paragraph in the answer now reads:
The approach is not applicable to the below instances where other approaches may be considered on a case-by-case basis in consultation with the appropriate regulatory authority:
- CAPA implementation exceeding 3 years from the date of publication of the initial AI (this date which starts the 3-years period will not change if the AI is subsequently revised, even in case of publication of more restrictive AI). In cases where CAPAs are not implemented within the agreed timeframe please refer to Q&A 20 for the regulatory steps taken by authorities.
- New/ongoing regulatory applications.
Source:
EMA: What’s New?
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