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 Grant of Drug and Manufacturing Licence in Loan
Premises
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Stage2
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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Procedure to Renew Drug Manufacturing Licence in loan premises
Licenses in Forms 25A, 28A, 25E can be renewed.
Stage 1
Application for renewal of Loan Manufacturing Licence
The applicant has to make application in the requisite form( 24A, 27A, 24E) 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
- Copy of the letter written to the own licence whose manufacturing capacity is decided to be utilised on loan.
- Copy of the consent letter of the own licencee who has agreed to give his manufacturing capacity to be utilised on loan.
- Label, cartons of all the drugs to be manufactured.
- Additional Information in Appendix (F).
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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