FDA Maharashtra
 
Monday, 21-Apr-2014
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 Grant of Drug and Cosmetic Manufacturing Licence in Own
   Premises


Stage 2

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 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
04 - Fees and Fines, etc.

Documents to be attached along with the application form:

  • Receipt for the fees paid or challan, (the fees are as given in Appendix A) as the case may be or their attested copies.

  • Copy of Approved layout plan of the manufacturing area.

  • Documents viz. Rent receipt, purchase documents or its attested copies showing  lawful possession of the premises

  • List of machinery and equipments.

  • Documents relating to the constitution of the firm viz. Partnership-deed, memorandum and article of association etc.

  • Full particulars of the competent technical staff employed for manufacturing and testing of drugs and cosmetics along with copies of their educational qualifications and experience certificates approval letter as competent staff. The competent technical staff is required to furnish consent letter for full time employment with the applicant firm.

  • List of Drugs Cosmetics in triplicate along-with undertaking to be submitted.

  • In case, the application is for the products covered under Schedule C and C (I) category, then the details of stability data  is required.

  • If the products are covered under ‘Patent and Proprietary’ definition, then the two copies of methods of Analysis of  the products be supplied.

  • Full name of the proprietor or the partners, as the case may be shall be provided in the application. In case of private  or public limited concerns, full name of the Directors who sign the application and the authorized signatory, if any, shall  be provided in the application .

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