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Certificates

Grant of Various Certificates for Drug Section

The following Certificates are issued to the Manufacturers.
  • WHO GMP Certificate/ Certificate of Pharmaceutical Products(COPP)
  • Performance Certificate/Marketing Manufacturing Certificate/COPP
  • No Conviction Certificate
  • GMP Certificate
  • Certificate of Approval for Technical Person
WHO GMP Certificate/ Certificate of Pharmaceutical Products(COPP)
Documents required :
  • Application in the Form of covering letter.
  • Document of the country where the products are to be exported.
  • List of Products to be exported in duplicate.
  • Stability studies of 3 batches of the product for which COPP is required(Both real time and accelerated).
Performance Certificate/Marketing Manufacturing Certificate/COPP
Documents required :
  • Application in the Form of covering letter.
  • Xerox copy of the licence
  • Xerox copy of the approved list of products for which the certificate is required along with copies of approval of the product for which certificate is required for the relevant period.
No Conviction Certificate
Documents required :
  • Application in the Form of covering letter.
  • Xerox copy of the licence
  • 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.
GMP Certificate
Documents required :
  • Application in the Form of covering letter.
  • Xerox copy of the licence
  • Xerox copy of list of approved products.
Certificate of Approval for Technical Person
Documents required :
  • Application in the Form of covering letter.
  • Educational qualification certificate.
  • 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 earlier approval/refusal letter ,if any.
Note :
  1. All applicant desired of having Performance Certificate/Marketing Certificate/COPP are required to submit their application to the concern SDCO for his verification/ Recommendation thereof.
  2. All applicant desired of having no conviction, GMP and application of technical person should submit the application directly to SDCO(Head Quater).