Guidance for submission of Biological Application (Vaccine)
1.
Notice,1
II
2.
Checklist
1.
Permission for Conducting Clinical Trial (Phase I, II and III)
2.
Global Clinical Trial
3.
Market authorization / New Drug approval
4.
Import License (Form 10)
5.
Registration Certificate (Form 41)
6.
Post approval Changes.
7.
Test License for import of drugs under Form 11
.
8.
NOC for manufacturing of test batches for test and analysis under Form 29.