In order to facilitate the acceptance of proposed changes in a timely manner, CEP holders are reminded that the European Directorate for the Quality of Medicines & HealthCare (EDQM) Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopoeia Monographs (PA/PH/CEP (04) 2, 7R corr) lists different notifications and associated conditions, and that any change not classified as a notification or a major change should be classified as a minor change by default (with the exception of editorial changes for which specific guidance is given in the policy document). If the change cannot be classified by the document and specifically as a notification, a minor revision (by default) should be submitted. Any submission of a notification which includes changes not classifiable as a notification will be rejected and the changes will then need to be resubmitted using the correct classification (with associated documentation and fee).
In particular, 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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