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)