kishorpatil
☆    

2010-11-30 07:00
(5678 d 18:15 ago)

Posting: # 6248
Views: 3,769
 

 NOC of Reference product [Regulatives / Guidelines]

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Dear all,

can anybody tell me what is the procedure to obtain the NO objection certificate (NOC) of Innovator product.

Regards
Kishor
 
bharathi
☆    

India,
2010-11-30 07:35
(5678 d 17:40 ago)

@ kishorpatil
Posting: # 6249
Views: 3,087
 

 NOC of Reference product

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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
 
patilatu
☆    

2010-12-09 08:34
(5669 d 16:41 ago)

(edited on 2010-12-09 10:25)
@ kishorpatil
Posting: # 6279
Views: 2,922
 

 NOC of Reference product

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Dear Kishor,

Bharthi is correct and for extra information you can visit to CDSCO site or dcgi official website.

Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]
 
pravin17
★    

India,
2010-12-13 10:18
(5665 d 14:57 ago)

(edited on 2010-12-13 13:27)
@ kishorpatil
Posting: # 6292
Views: 2,912
 

 NOC of Reference product

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Dear Kishor

You go through link provided and will get all idea. http://cdsco.nic.in/BE%20Guideline.doc

Pravin Borde

Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Jaime]
 
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