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.