Validity of DCGI BE NOC for Drug Products for BE studies [Regulatives / Guidelines]

posted by taresh41  – Mumbai, 2011-05-11 10:28 (5525 d 12:43 ago) – Posting: # 7000
Views: 5,049

Hello,

I am intrested in knowing that till how much time DCGI BE NOC for a drug product is valid from the date of approval by DCGI, i.e in what time time period (within 1 or 2 or 3 years after getting the DCGI BE NOC) i will have to use the DCGI BE NOC for conduct of Bioequivalence study before it expires.

Kindly also send me reference for the same if any.

Thanks in advance.

Regards,
Taresh

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