EDQM Releases Updated Guideline: "How to Read a CEP"

In May, the European Directorate for the Quality of Medicines & HealthCare (EDQM) published the first revision of its guideline titled "How to Read a CEP" (PA/PH/CEP (15) 31, 1R). This update reflects changes brought about by the introduction of CEP 2.0 in 2023 and aims to provide clearer guidance on interpreting the three current Certificate of Suitability (CEP) formats: CEP 2.0, Hybrid CEP, and the original CEP.

The revised guideline is structured into five main chapters, with additional subsections included in Chapters 4 and 5 for detailed clarification. The updated layout is as follows:

• 4.1. CEP 2.0 and Hybrid CEP
• 4.1.1. Numbering
• 4.1.2. CEP Letter of Access
• 4.1.3. Sites
• 4.2. Original CEP
• 4.2.1. Numbering
• 4.2.2. Declaration of Access Box
• 4.2.3. Sites

• 5.1. CEP 2.0 Content
• 5.1.1. Chemical CEP Statements
• 5.1.2. Herbal CEP Statements
• 5.1.3. TSE CEP Statements
• 5.2. Original CEP Content
• 5.2.1. Chemical CEP Statements
• 5.2.2. Herbal CEP Statements
• 5.2.3. TSE CEP Statements
• 5.3. Hybrid CEP Content
• 5.3.1. Chemical CEP Statements
• 5.3.2. Herbal CEP Statements
• 5.3.3. TSE CEP Statements

List of Abbreviations

The full revised guideline can be accessed through the EDQM website under the “Certification Policy Documents & Guidelines” section, within “General Documents.”

08-06-2025