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| Grant of Various Certificates for Drug Section |
| The following Certificates are issued to the Manufacturers. |
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WHO GMP Certificate.
- Certificate of Pharmaceutical Products. (COPP)
- Performance Certificate.
- Non-Conviction Certificate.
- Market Standing
Certificate.
| WHO GMP Certificate/ Certificate of Pharmaceutical Products.(COPP) |
| This certificate is granted to Allopathic Drug Manufacturing Units only. |
- Application in the Form of
covering letter.
- Fees as mentioned in Appendix A to
be paid.
- Document of the country where the products are
to be exported.
- List of Products to be exported in
duplicate.
- Xerox copy of list of approved products.
- Site Master File.
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Application in the Form of covering letter.
- Fees as mentioned in Appendix A to be paid.
- Xerox copy of the license and latest
valid renewal certificate
- Xerox copy of the approved list of products for which the certificate is required.
- Certificate from Chartered
Accountant regarding production and sale details
of products for which application is made.
- A letter from authority concerned who
has demanded the certificate.
- Application in the Form of covering letter.
- Fees as mentioned in Appendix A to be paid.
- Xerox copy of the license and latest valid renewal certificate
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Xerox copy of the approved list of products for which
the certificate is required.
- Certificate from Chartered
Accountant regarding production and sale
details of products for which application is
made.
- Letter of the
concerned authority demanding certificate.
| No Conviction Certificate. |
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Application in the Form of covering letter.
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Fees as mentioned in Appendix A to be
paid.
- Xerox copy of the license and
latest valid renewal certificate
- The
list of drugs in duplicate for which the Certificate is
required.
- Name of the proprietor Certificate
from Chartered Accountant regarding production and sale
details of products for which application is made.
- Letter of the concerned authority
demanding certificate.
| Schedule M Compliance Certificate. |
- Application
in the Form of covering letter.
- Fees as
mentioned in Appendix A to be paid.
- Xerox
copy of the license and latest valid renewal certificate.
- The Licensed Drugs and Cosmetics
Manufacturers can apply for permission to manufacture
Additional Drug Products,
Cosmetic Products from time to
time.
Download
Appendix A
| Certificate of Approval for Technical Person |
- Application in the Form of covering letter.
- Educational qualification certificate.
- Fees as mentioned in Appendix A to be paid.
- Xerox copy of the Appointment and Acceptance letter of the canditate .
- Certificate of experience in the section in which approval is sought .
- Copy of letter of FDA for having taken a note of such appointment in that section.
- Copy of documentary evidence of having left the previous service.
- Copy of marriage certificate in case of female candidate.
- Copy of earlier approval/refusal letter ,if any.
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