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Companies should avoid including in CEP dossiers any information that would not be approved by the EDQM (e.g. information on micronisation if no grade is claimed). Although some direction may be given by the EDQM during an ongoing assessment, it is the responsibility of the CEP holder to remove non-approved information from the dossier. This can be done by means of a submission of an appropriately updated eCTD* sequence during the ongoing assessment. Any deletions should be justified and appropriately shown in a comparative table.

(*eCTD or VNeeS for substances for veterinary use only and PDF for TSE risk applications).

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