DCGI application for change in RLD [Regulatives / Guidelines]

posted by docksr – India, 2013-06-22 10:29 (4750 d 15:00 ago) – Posting: # 10863
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❝ You need to go for new DCGI BENOC application if the RLD is being changed.


Thank you Dr Gunasakaran for the clarification. I was wondering when both the RLDs are approved by FDA, why DCGI should insist for new BENOC ? Notification should suffice for a change of RLD !

Regards,
Dr.Sudakar Reddy

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]

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