The extension is to allow companies to carry out a thorough investigation and identify any necessary risk mitigation measures, in particular regarding nitrosamines that may result from active substances. This extension does not affect the deadline for the completion of the level 2 confirmatory tests for chemical medicinal products. This will continue to end on 26 September 2022, by which time marketing authorisation holders should submit the full results of stage 2.
Certificates of Suitability
A similar approach is taken for Certificates of Suitability (CEP) and therefore the previously announced deadline (notice to all CEP holders for synthetic active substances regarding the presence of nitrosamines) for the submission of all necessary revisions under Step 3 is thus extended to 1 October 2023. Nevertheless, CEP holders are invited to submit their amendments as soon as the investigations are completed and thus before the deadline mentioned above.
Q&A document on nitrosamine impurities
The changes are also reflected in the accompanying Q&A document. Question 3 on the “call for review” has been updated accordingly:
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