FDA Maharashtra
 
Friday, 18-May-2012
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 Grant of Drug and Cosmetic Manufacturing Licence in Own
   Premises


Stage3

Inspection

The application is scrutinized and premises inspected.

Stage 4

Grant of Licence

If all conditions as prescribed by the act are complied licence is granted
 
Down Load
Application Forms  2424B  , 24C24D, 2727C27D , 31  
Details of Fees Appendix A
 
 
Procedure to Renew Drug Manufacturing Licence


Licences in Forms 25, 25B, 25C,25D, 25F, 28, 28B,28C,28 D can be renewed.

Stage 1

Application for grant of Own Manufacturing Licence

The applicant has to make application in the requisite Form ( 24, 24B, 24C, 27, 27C, 27D)and pay necessary fees as given in fee chart in Appendix A .
The mode of payment of fees is same as fresh licence.
 
Documents to be enclosed along with application of renewal of licence :-

  • Copy of cash receipt or challan for payment of fees.

  • Xerox copy of Licence /Previous renewal certificate.

  • Xerox copy of the list of Drugs previously approved.

  • List of Drugs along with names of proprietary medicines and dates of its approval (two copies).

  • Full particulars of the competent technical staff appointed for
    manufacturing and testing along with their educational qualification and experience certificates.

Stage 2

Inspection

The application is scrutinized and premises inspected.

Stage 3

Grant of Licence

If all conditions as prescribed by the act are complied licence is granted

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