FDA Maharashtra
Thursday, 09-Sep-2010
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Grant of Drug and Cosmetics Manufacturing Licence in Loan Premises
Food and Drug Administration M.S. Grants Manufacturing Licences for Drugs ( Allopathy, Ayurvedic, Siddha, Unani ) and Cosmetics to be carried out in Loan premises in Forms 25,A 28A, 25E and 32 A
Procedure to obtain Drug Manufacturing Licence (Fresh) in Loan Premises
Stage 1
Application for grant of Loan Manufacturing Licence
The applicant has to make application in the requisite application form in Form
24A
,
27A
,
24E
respectively and pay necessary fees as given in
fee chart
in Appendix A .
Fee can be paid in cash at Head Office/Division as well as any other District Officer.The fee can also be paid through challan at Government Treasury, Reserve bank of India, State Bank of India and State Bank of Hyderabad for Maratha Wada Region under Head Account-----
0210 - Medical and Public Health.
04 - Public Health
104 - Fees and Fines, etc.
Documents to be attached along with the application form :
Receipt of payment of Fees.
Documents such as partnership-deed, Memorandum and Articles of Association.
List of Drugs/Cosmetics to be manufactured in duplicate.
Copy of the letter written to the manufacturer whose premises, machinery equipments are to be taken on loan.
Copy of consent letter of the manufacturer who gives his premises, Machinery and equipments on loan. Labels and cartons of the Drugs to be manufactured.
In case, the application is for the products covered under C and C (1) category, then the details of stability data are required.
If the products are covered under ‘Patent and Proprietary’ definition, then the two Copies of methods of Analysis of the products be supplied.
Additional Information in Appendix (F) .
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