EP升级，CEP修订

kexiwei

EP9.3 2018.01.01生效，我们有个产品的专论升级了，涉及的是Case A
• Case A:
The specification of the substance should be updated according to the revised monograph. Unless the CEP holder has made reference to the “current version of the monograph” (without providing details on the Ph. Eur. tests and methods in the CEP application), the updated specification should be included in the next request for revision that is submitted to EDQM (minor, major or renewal of the certificate) and identified as such at that time (such an update will be free of charge). Where the CEP holder has made reference to the “current version of the monograph”, the revised monograph should be implemented without the need to update the specification of the substance at the next request for revision.
红色字体的意思是：如果Holder没有参考现行的专论，在下次修订时需要一并升级标准。
1.        其中Current version of the monograph,是指EP9.3吗？
2.        如果升级后的药典标准比我们已经批准CEP的标准松，我们必须要和升级后的药典标准一致吗？
期待各位大神回复。谢谢！

xwytaohang

前来学习下

cnosema

EP9.3 是2018-1-1 之后的现行版本，目前的现行版本不是9.3 哈。

114363808

来学习了，谢谢