DMF装订要求.docVIP

IV. D. Format, Assembly, and Delivery IV.D .格式、装配和交付 IV. D.1. IV. D.1. An original and duplicate are to be submitted for all DMF submissions. 所有DMF的提交均须提交一份原件和一份副本。 Drug Master File holders and their agents/representatives should retain a complete reference copy that is identical to, and maintained in the same chronological order as, their submissions to FDA. 药物主文件持有者和他们的代理/代表应该保留一个完整的参考副本,该副本应与提交到FDA的相同，且保持同样的时间顺序。 IV. D.2. IV. D.2. The original and duplicate copies must be collated, fully assembled, and individually jacketed. 原件和副本必须经整理,完全装订,独立封面。 Each volume of a DMF should, in general, be