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requirements for Issues of Certificates

DOCUMENTS TO BE SUBMITTED FOR ISSUE OF CERTIFICATES

(a)-  REQUIREMENTS FOR ISSUE OF G.M.P CERTIFICATE

i. Covering letter with brief introducing the firm with factory and Office address and purpose of GMP Certificate

ii. User charges ( Receipt in Original) fee of Rs.1500/- remitting the fee in Head of account

0210    – Medical and Public Health
04        - Public Health,
800      - other receipts (Drugs Control)

iii. Copies of Manufacturing Licence in Form 25 / 28.

iv. Copy of the WHO GMP Certificate/ GMP Certificate issued earlier if any.

 

(b)- REQUIREMENT  FOR ISSUE OF  W H O -  G M P CERTIFICATE.

i. Covering letter with brief introducing the firm with factory and Office address and purpose of WHO GMP Certificate

ii. User charges ( Receipt in Original) fee of Rs.1000/- per each product remitting the fee in Head of account

0210    – Medical and Public Health
04        - Public Health,
800      - other receipts (Drugs Control)

iii.List of the Products required for   W H O – G M P Certification

iv. Copies of Manufacturing Licence in Form 25 / 28.

v. Copy of the WHO GMP Certificate issued earlier if any.

vi. Stability studies data of the applied products

vii. Site Master File.

 

(c)- Requirements for issue of COPPs

i.Copy of  valid  W H O  G M P  Certificate

ii. User charges ( Receipt in Original) fee of Rs.500/- per each product per each country remitting the fee in Head of account

0210    – Medical and Public Health
04        - Public Health,
800      - other receipts (Drugs Control)

ii. Copies of Master formula Records- wherever required.

iv. Copies of the Product Licensees.

 

(d)- Requirements for issue of  Free Sale Certificate,

i. Covering letter with brief introducing the firm with factory and Office address and purpose of Free Sale Certificate

ii. User charges ( Receipt in Original) fee of Rs.200/- per each product remitting the fee in Head of account

0210    – Medical and Public Health
04        - Public Health,
800      - other receipts (Drugs Control)

iv. List of the Products required  Free Sale Certification

v. Copies of Manufacturing Licence in Form 25 / 28.

vi. Proof of availability of same product in Indian Market, with similar labels

 

 (e)-  Requirements for issue of a Market Standing Certificate

i. List of the Products required Market Standing Certificate

ii. User charges ( Receipt in Original) fee of Rs.500/- up to 5 products and 100/-  per each additional product remitting the fee in Head of account

0210    – Medical and Public Health
04        - Public Health,
800      - other receipts (Drugs Control)