FDA Maharashtra
 
Wednesday, 08-Feb-2012
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 Grant of Various Certificates for Drug Section
 

The following Certificates are issued to the Manufacturers.
  1. WHO GMP Certificate.
  2. Certificate of Pharmaceutical Products. (COPP)
  3. Performance Certificate.
  4. Free Sale Certificate.
  5. No Conviction Certificate.
  6. GMP Certificate.
  7. Certificate of approval for Technical Person.
WHO GMP Certificate/ Certificate of Pharmaceutical Products.(COPP)
 
This certificate is granted to Allopathic Drug Manufacturing Units only.
 
Documents required :
  1. Application in the Form of covering letter.
  2. Fees as mentioned  in  Appendix A to be paid.
  3. Document of the country where the products are to be  exported.
  4. List of Products to be exported  in duplicate.
  5. Xerox copy of list of approved products.
  6. Site Master File.
 
Performance Certificate.
 
Documents required:
 
  1. Application in the Form of covering letter.
  2. Fees as mentioned in Appendix  A to be paid.
  3. Xerox copy of the licence and latest valid renewal certificate
  4. Xerox copy of the approved list of products for which the certificate is required.
  5. Certificate from Chartered Accountant  regarding production and sale details of products for which application is made.
  6. A letter from authority concerned who has demanded the certificate.

 
Free Sale certificate.
 
Documents required:

  1. Application in the Form of covering letter.
  2. Fees as mentioned in Appendix A to be paid.
  3. Xerox copy of the licence and latest valid renewal certificate
  4. Xerox copy of the approved list of products for which the certificate is required.
  5. Certificate from Chartered Accountant regarding production and sale details  of products for which application is made.
  6. Letter of the concerned authority demanding certificate.
 
No Conviction  Certificate.
 
Documents required:

  1. Application in the Form of covering letter.
  2. Fees as mentioned in Appendix A to be paid.
  3. Xerox copy of the licence and latest valid renewal certificate
  4. The list of drugs in duplicate for which the Certificate is required.
  5. Name of the proprietor Certificate from Chartered Accountant regarding production and sale details of products for which application is made.
  6. Letter of the concerned authority demanding certificate.
 
GMP Certificate.
 
Documents required:

  1. Application in the Form of covering letter.
  2. Fees as mentioned in Appendix A to be paid.
  3. Xerox copy of the licence and latest valid renewal certificate.
  4. Xerox copy of list of approved products.

Certificate of Approval for Technical Person
 
Documents required:

  1. Application in the Form of covering letter.
  2. Educational qualification certificate.
  3. Fees as mentioned in Appendix A to be paid.
  4. Xerox copy of the Appointment and Acceptance letter of the canditate .
  5. Certificate of experience in the section in which approval is sought .
  6. Copy of letter of FDA for having taken a note of such appointment in that section.
  7. Copy of documentary evidence of having left the previous service.
  8. Copy of marriage certificate in case of female candidate.
  9. Copy of earlier approval/refusal letter ,if any.
 
 
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