NOC of Reference product [Regulatives / Guidelines]

posted by bharathi – India, 2010-11-30 07:35 (5689 d 11:51 ago) – Posting: # 6249
Views: 3,114

Dear Kishore,

Apply to DCGI for Reference product with the following documents enclosed:
  1. Form - 12 (Application for license to import drugs for the purpose of bioequivalence study)
  2. Material consumption plan (list the requirement of reference product)
  3. Detailed information on previous import of the same reference product
  4. Declaration that the drugs will be used for BE study
  5. Form - 44 (Application for grant of permission to import a new drug to undertake a clinical trial)
  6. COAs of test and reference product
  7. Authority letter (conforming that the imported product will used for BE study)
  8. First marketing approval status of the drug
  9. Product insert of the reference product
  10. Facility approval letter (CRO & Mfg site)
  11. Investigators undertaking the study
  12. Clinical study protocol and English ICF
  13. Challan

Regards,
Bharathi

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