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Manufacturer's Licence for Medicinal Product
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Fees
1.
APPLICATION FOR A LICENCE FOR:
(a)
Manufacture of external preparations OR oral preparations OR contact lens solutions
$1,500
(b)
Manufacture of external preparations AND oral preparations
$2,000
(c)
Manufacture of sterile preparations or other types of dosage forms, or dosage forms combinations other than the above
$3,000
(d)
Primary assembly
$1,000
(e)
Secondary assembly
$600
2.
LICENCE FOR:
(a)
the first year
No charge
(b)
each subsequent year
—
(i)
a manufacturer of external preparations OR oral preparations OR contact lens solutions
$1,500
(ii)
a manufacturer of external preparations AND oral preparations
$2,000
(iii)
a manufacturer of sterile preparations or other types of dosage forms, or dosage forms combinations other than the above
$3,000
(iv)
a primary assembler
$1,000
(v)
a secondary assembler
$600
3.
APPLICATION TO AMEND A LICENCE:
(a)
with site inspection (for manufacturer)
$1,000
(b)
with site inspection (for assembler)
$500
(c)
without site inspection
$50
Related Links
Medicines
Reclassified Medicines
Good Manufacturing Practice & Licensing of Premises
GMP and GDP Standard
Safety Information and Recalls
Last updated on 02 Jul 2010 16:43:24