1. Gap Analysis & Pre-assessment: Evaluate company's hardware/software compliance with CEP requirements and develop rectification strategies.

2. Documentation Preparation & Submission: Prepare CTD/eCTD files including Modules M1-M3.

3. Lifecycle Management: Assist with CEP variations (e.g., annual deficiency responses, annual reports, major changes) and certificate renewals.

4. Regulatory Monitoring: Track real-time updates on EU/EDQM policy changes to mitigate compliance risks.

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1. Definition and Background

The Certificate of Suitability to Monograph of European Pharmacopoeia (previously abbreviated as COS, now CEP) is issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM) and applies to substances included in the European Pharmacopoeia.

The CEP certificate is recognized by all EU member states and some non-member countries.

2. Applicable Registration Scope

Applies to substances included in the European Pharmacopoeia.

3. Basic Registration Requirements

·Must strictly comply with the technical requirements of European Pharmacopoeia monographs to demonstrate the quality, safety and consistency of the active substance.

·Submission content focuses on pharmacopoeial compliance, including manufacturing process, impurity control, stability data, etc.

4. Registration Process

CEP documentation preparation (application form, CTD dossier) → CESP account application → Submission to EDQM → Fee payment → Obtain CEP application number and initiate evaluation → EDQM review → Deficiency response → Obtain CEP certificate.

5. Regulatory Basis

·Directive 2001/83/EC: General framework for human medicines regulation, covering marketing authorization, manufacturing, labeling, advertising, etc.

·Content of the dossier for chemical purity and microbiological quality of substances for pharmaceutical use