权威医学用药书籍速查系统

4. CONSIDERATIONS FOR IMPLEMENTATION

When sponsors or manufacturers change their existing methods to the implemented Q4B-evaluated pharmacopoeial texts that are referenced in Section 2 of this annex , any change notification , variation .And/or prior approval procedures should be handled in accordance with established regional regulatory mechanisms pertaining to compendial changes .In accordance with the conditions set out in this annex , as fulfilling the requirements for compliance with the Ph . Eur . Chapte 5.1.4 . on the basis of the declaration of interchangeability made above .

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——《2011药品注册的国际技术要求.质量部分》
书名:《2011药品注册的国际技术要求.质量部分》
栏目:2011药品注册的国际技术要求.质量部分 > EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS ON MICROBIOLOGICAL EXAMINATION OF NON-STERILE PRODUCTS: ACCEPTANCE CRITERIA FOR PHARMACEUTICAL PREPARATIONS AND SUBSTANCES FOR PHARMACEUTICAL USE GENERAL CHAPTER Q4B ANNEX
作者:美国ICH指导委员会 周海钧
参编:王执,王知坚,匡荣,李洋,张洁
页码:328-329
版本:1
出版时间:2011-01-01
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