durva
☆    

India,
2013-02-07 14:33
(4890 d 06:45 ago)

Posting: # 9987
Views: 3,194
 

 In which case BE NOC is required? [Regulatives / Guidelines]

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Dear All,

In which case BE NOC is required and not required?

can you help me in this regards.
 
luvblooms
★★  

India,
2013-02-08 07:33
(4889 d 13:46 ago)

@ durva
Posting: # 9991
Views: 2,706
 

 In which case BE NOC is required?

Post reply
Dear Durva

If your drug is intended for export purpose, BENOC is required for
  1. A new molecule not approved in India but approved in the other countries
  2. New Drugs approved in India within period of 1 year
  3. New Drugs approved within period of more than 1 year & less than 4 years
  4. A drug product in modified release form irrespective of their approval status (as per our recent communication with DCGI, this BENOC is required even for DR/GR prazoles as well.
    :ponder:

Details can be obtained from this link


Hope this will help
—
~A happy Soul~
 
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