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| Grant of Additional Product Licence Drug Manufacturing License. |
| The Licensed Drugs and Cosmetics
Manufacturers can apply for permission to manufacture
Additional Drug Products,Cosmetic Products from time to
time. |
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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.
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| 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.
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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 license
is granted. |
Download
Appendix A
Appendix B |
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