【法規新訊】EDQM已開始實施CEP 2.0
2024 年 1 月 10 日
自2023年9月起，EDQM已開始實施新版CEP：CEP 2.0，與舊版最大的差別在於電子化，並自實施日起，CEP持有者可在提供所需檔案資料後將原有CEP轉換為CEP 2.0。相關資訊請參考EDQM網頁。
| CEP 2.0 | Hybrid CEP | Old CEP | |
| Format | Electronic document | Paper document | |
| Electronic signature | Wet signature | ||
| Numbering | 2-block alphanumerical codeCEP 20XX-XXX-Rev 00 | 3-block alphanumerical codeR0-CEP 20XX-XXX-Rev 00 | |
| Information on companies | Name and address of the holder and production sites completed by SPOR OMS LOC &ORG ID | Name and address of holder and production sites | |
| Technical information (CHEM AND HERBAL) | Inclusion of the approved specification inclusion of description of additional methods required to control the substance | Limits for additional impurities and inclusion of additional tests used in addition to the Ph. Eur. monograph tests, required to control the substance. | |
| Expiry date | NoNo reference to a validity date of 5 years (renewal is due date, on public data base) | Yes | |
| Box of Acces- Letter of Access | Letter of Access (seperate document)Template available on EDQM website | Box of accessOn the CEP | |