No. S 387
Medicines Act
(Chapter 176)
Medicines (Licensing, Standard Provisions and Fees) (Amendment) Regulations 1997
In exercise of the powers conferred by section 74 of the Medicines Act, the Minister for Health hereby makes the following Regulations:
Citation and commencement
1.  These Regulations may be cited as the Medicines (Licensing, Standard Provisions and Fees) (Amendment) Regulations 1997 and shall come into operation on 1st October 1997.
Amendment of regulation 4
2.  Regulation 4 of the Medicines (Licensing, Standard Provisions and Fees) Regulations (Rg 6) is amended by deleting paragraph (1) and substituting the following paragraph:
“(1)  The fees in respect of applications for, and the grant of, licences and certificates and for any variation or amendment thereof shall be as set out in the Fifth Schedule.”.
Deletion and substitution of Fifth Schedule
3.  The Fifth Schedule to the Medicines (Licensing, Standard Provisions and Fees) Regulations is deleted and the following Schedule substituted therefor:
“FIFTH SCHEDULE
Regulation 4(1)
FEES FOR LICENSES AND CERTIFICATES
(A)Product Licence
 
(a)For each application for an ordinary licence or a provisional licence for an existing product
$160.
(b)For each application for an ordinary licence or a provisional licence for a new product
$300.
(c)For each ordinary licence issued for an existing product
$60.
(d)For each provisional licence issued for an existing product
$20.
(e)For each ordinary licence issued for a new product
$240.
(f)For each provisional licence issued for a new product
$60.
(B)Import licence
 
(a)For each licence issued to a person authorised by a product licence holder to import medicinal products
$100.
(b)For each consignment of a medicinal product imported by a person other than a person authorised to import a medicinal product by the product licence holder
$60.
(C)Wholesale Dealer’s licence
 
(a)For each application for a licence to sell medicinal products by way of wholesale dealing
$170.
(b)For each licence to sell medicinal products by way of wholesale dealing
$100.
(D)Manufacturer’s licence
 
(a)For each application for a licence to manufacture and assemble medicinal products
$945.
(b)For each licence to manufacture and assemble medicinal products
$400.
(c)For each application for a licence to assemble medicinal products
$200.
(d)For each licence to assemble medicinal products
$100.
(E)Certificate for Exporter of Medicinal Products for each product
$30.
(F)Any variation or amendment to a licence or certificate on any single occasion
$20.”.
[G.N. Nos. S 277/92; S 99/96]
Made this 21st day of August 1997.
KOH YONG GUAN
Permanent Secretary,
Ministry of Health,
Singapore.
[PD (DAD) 36:36/1; AG/LEG/SL/176/95/2 Vol. 2]
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