Test License [Regulatives / Guidelines]
Dear RK,
Yes, you will need.
Regards,
Osama
❝ 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.
Yes, you will need.
Regards,
Osama
—
Cheers,
Osama
Cheers,
Osama
Complete thread:
- Test License rajasekharkakarla 2018-10-06 08:05 [Regulatives / Guidelines]
- Test License Obinoscopy 2018-10-06 12:58
- Test Licensewienui 2018-10-07 21:04
- Remaining RLDs from pilot study qualityassurance 2023-09-28 12:29
- Remaining RLDs from pilot study wienui 2023-09-28 18:12
- Remaining RLDs from pilot study- retention sample? dshah 2023-10-03 17:27
- Remaining RLDs from pilot study qualityassurance 2023-09-28 12:29