null CEP holders – How to submit a nitrosamine risk assessment

EDQM Strasbourg, France 30/01/2023
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CEP holders – How to submit a nitrosamine risk assessment

To facilitate the acceptance of proposed changes in a timely manner, the European Directorate for the Quality of Medicines & HealthCare (EDQM) would like to draw the attention of CEP holders to the following details regard minor revisions.

Minor revisions should be submitted for revised discussions on impurities in section 3.2.S.3.2, or for submission of nitrosamine risk assessment (the deadline for the submission of risk assessments outside revision applications was 31 July 2020, see news of 27 March 2020: “Deadline extension to all CEP holders to complete step 1 Risk Assessments regarding presence of nitrosamines (now 31 July 2020)”). CEP holders are also reminded that if changes to the synthesis or to the control strategy are introduced to reduce or eliminate the risk for the formation of nitrosamine impurities or other mutagenic impurities, they should be suitably classified according to the EDQM guideline (minor, major revision or sister file application).

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