Test License [Regulatives / Guidelines]

posted by wienui  – Germany, Oman, 2018-10-07 21:04 (1030 d 22:39 ago) – Posting: # 19414
Views: 1,489

Dear RK,

» 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
No, You can't use the rest of the reference drug for conducting a BE Study with a new ordered reference drug batch, as they are two different Batches ( Biobatches).

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

Yes, you will need.

Regards,

Osama

Cheers,
Osama

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