FDA Maharashtra
 
Wednesday, 08-Feb-2012
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 Grant of Additional Product Permission

The Licensed Drugs and Cosmetics Manufacturers can apply for permission to manufacture Additional Drug Products,Cosmetic Products from time to time.
 
Procedure for grant of Additional Product Permission.


Stage 1

Application
An application for permission to manufacture additional Drugs Products, Cosmetic Products  is to be made to the concerned Licensing Authority .

The Covering letter of the application should mention all the details like firms expertise to manufacture the drug/cosmetics, manufacturing facilities etc.
 
Documents to be attached along with the Application
  • List of products along with an undertaking in duplicate (as per Appendix B) duly signed by the person In charge of Production, Managing Director, Owner, Partner or Director as the case may be .

  • Stability data in Case of multivitamin products.

  • In respect of a patent or proprietary drug product, information and therapeutic justification, indications, contra-indications, dosage schedule, availability  of similar products in the market along with the method of analysis.

  • In case of cosmetic additional product method of analysis and requisite BIS standard  references .

  • In case of Ayurvedic , Unani ,Siddha product references regarding ingredients .

 
  • Copy of cash receipt/challan showing the payment of prescribed fees.

Stage 2

Scrutiny

The application is scrutinized and if required premises inspected .


Stage 3

Grant of Additional Product Permission
 
If all conditions as prescribed by the act are complied licence is granted.
 
 
 
 
 
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