Bioequivalence and Bioavailability Forum 17:49 CET

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Test License [Regulatives / Guidelines]

posted by rajasekharkakarla - India, 2018-10-06 08:05  - Posting: # 19411
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Dear All,

I applied Test license for some X drug in India, I got permission and I imported the drug (reference) from outside India then conducted one study (pilot). Now I want to conduct one more study (pivotal) with remaining quantity of Reference drug from first study. Here I have some doubts:

1) Can I use remaining quantity of reference drug for pivotal

2) If we use remaining IPs, Is we need to get Test license permission for pivotal.

or

Is we need to apply fresh Test license to import Reference drug separately for pivotal.

Please guide me to overcome this issue.

Regards,
RK

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