Test License [Regulatives / Guidelines]

posted by rajasekharkakarla – India, 2018-10-06 08:05 (1022 d 07:18 ago) – Posting: # 19411
Views: 1,822

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

Complete thread:

Activity
 Admin contact
21,589 posts in 4,512 threads, 1,530 registered users;
online 10 (0 registered, 10 guests [including 5 identified bots]).
Forum time: Saturday 15:24 CEST (Europe/Vienna)

There are no dangerous thoughts;
thinking itself is dangerous.    Hannah Arendt

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5