EDQM: Confidentiality and Declassification of CEP Documents
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has elaborated a document describing the principles for the declassification of documents pertaining to the CEP (Certificate of Suitability to the Monographs of the European Pharmacopoeia) procedure while ensuring when necessary, the confidentiality of information.
The guide outlines principles to balance transparency with confidentiality, focusing on maintaining the secrecy of commercial information and protecting the identities of assessors and inspectors involved in the CEP process.
The guide also specifies that documents of a non-public nature, including CEP applications, assessment reports, and manufacturing inspection data, will not be declassified.
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