EDQM: Update of Guideline "How to read a CEP"

In May, the first revision of the guideline "How to read a CEP (PA/PH/CEP (15) 31, 1R)" was published on the EDQM (European Directorate for the Quality of Medicines & HealthCare) website. It mainly contains updates resulting from the introduction of CEP 2.0 in 2023. The three formats of the CEP that now exist (CEP 2.0, Hybrid CEP and CEP) are clearly presented in the new version.

The guideline consists of five chapters, with chapters 4 and 5 containing further subsections. The updated guideline now contains the following structure:

1. INTRODUCTION
2. AIM AND SCOPE OF A CEP
3. GENERAL CONSIDERATIONS
4. CEP FORMATS
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. OLD CEP
4.2.1. NUMBERING
4.2.2. DECLARATION OF ACCESS BOX
4.2.3. SITES
5. CONTENT OF CEPS
5.1. CONTENT OF CEP 2.0
5.1.1. STATEMENTS ON A CHEMICAL CEP
5.1.2. STATEMENTS ON A HERBAL CEP
5.1.3. STATEMENTS ON A TSE CEP
5.2. CONTENT OF OLD CEPS
5.2.1. STATEMENTS ON AN OLD CHEMICAL CEP
5.2.2. STATEMENTS ON AN OLD HERBAL CEP
5.2.3. STATEMENTS ON AN OLD TSE CEP
5.3. CONTENT OF A HYBRID CEP
5.3.1. STATEMENTS ON A CHEMICAL CEP
5.3.2. STATEMENTS ON A HERBAL CEP
5.3.3. STATEMENTS ON A TSE CEP
LIST OF ABBREVIATIONS

On the EDQM website you can view the updated guideline "How to read a CEP (PA/PH/CEP (15) 31, 1R)" in the "Certification Policy Documents & Guidelines" section under "General documents".