No. S 416
Medicines Act
(Chapter 176)
Medicines (Licensing, Standard Provisions and Fees) (Amendment) Regulations 2005
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 2005 and shall come into operation on 1st July 2005.
Deletion and substitution of regulation 4
2.  Regulation 4 of the Medicines (Licensing, Standard Provisions and Fees) Regulations (Rg 6) is deleted and the following regulation substituted therefor:
Grant of licences
4.—(1)  Every product licence, wholesale dealer’s licence and manufacturer’s licence granted shall be for a period of one year or such shorter period as specified in that licence.
(2)  Every import licence granted to any person authorised by the holder of a product licence shall be for a period of one year or such shorter period as specified in the licence.
(3)  Every import licence granted to any person not authorised by the holder of a product licence shall be on a per consignment basis.
(4)  Notwithstanding paragraphs (2) and (3), every import licence granted in respect of Chinese proprietary medicines shall be for a period of one year or such shorter period as specified in the licence.”.
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 5(1)
FEES FOR LICENCES AND CERTIFICATES
PART I
WESTERN MEDICINES
1. PRODUCT LICENCE
 
 
(1) Application for a licence*
 
$240
(2) Licence for —
 
 
(a) the first year
 
No charge
(b) each subsequent year
 
$60
(3) Application to amend a licence
 
$20
2. IMPORT LICENCE
 
 
(1) Application for a licence* for —
 
 
(a) importation authorised by product licence holder
 
$35
(b) importation not authorised by product licence holder — per consignment imported
 
$60
(2) Licence for —
 
 
(a) importation authorised by product licence holder for —
 
 
(i) the first year
 
No charge
(ii) each subsequent year
 
$35
(b) importation not authorised by product licence holder — per consignment imported
 
No charge
(3) Application to amend a licence
 
$20
3. WHOLESALE DEALER’S LICENCE
 
 
(1) Application for a licence*
 
$60
(2) Licence for —
 
 
(a) the first year
 
$35
(b) each subsequent year
 
$95
(3) Application to amend a licence
 
$20
4. MANUFACTURER’S LICENCE
 
 
(1) Application for a licence* for —
 
 
(a) manufacture
 
$315
(b) assembly
 
$70
(2) Licence for —
 
 
(a) the first year for —
 
 
(i) a manufacturer
 
$135
(ii) an assembler
 
$35
(b) each subsequent year for —
 
 
(i) a manufacturer
 
$450
(ii) an assembler
 
$105
(3) Application to amend a licence
 
$20
5. CERTIFICATES AND DOCUMENTS
(NON-MANDATORY)
 
 
(1) a Certificate to Export a Medicinal Product
 
$50
(2) a Confirmation of Authorisation to Import Psychotropic Substances
 
$100
(3) a Confirmation of Authorisation to Import Restricted Substances
 
$100
(4) a Statement of Licensing Status of a Medicinal Product
 
$50
 
 
 
PART II
CHINESE PROPRIETARY MEDICINE
1. IMPORT LICENCE
 
 
(1) Application for a licence*
 
$330
(2) Licence for —
 
 
(a) the first year
 
$35
(b) each subsequent year
 
$365
(3) Application to amend a licence
 
$20
2. WHOLESALE DEALER’S LICENCE
 
 
(1) Application for a licence*
 
$65
(2) Licence for —
 
 
(a) the first year
 
$35
(b) each subsequent year
 
$100
(3) Application to amend a licence
 
$20
3. MANUFACTURER’S LICENCE
 
 
(1) Application for a licence* for —
 
 
(a) manufacture
 
$455
(b) assembly
 
$75
(2) Licence for —
 
 
(a) the first year for —
 
 
(i) a manufacturer
 
$35
(ii) an assembler
 
$35
(b) each subsequent year for —
 
 
(i) a manufacturer
 
$490
(ii) an assembler
 
$110
(3) Application to amend a licence
 
$20
4. CERTIFICATES (NON-MANDATORY)
 
 
a Certificate to Export a Chinese Proprietary Medicine
 
$50.
 
 
 
* Fees are payable upon acceptance of application.”.
 
 
[G.N. Nos. S 309/2001; S 641/2002; S 621/2003; S 384/2004]

Made this 20th day of June 2005.

MOSES LEE
Permanent Secretary,
Ministry of Health,
Singapore.
[HSA 700:69/01-000; AG/LEG/SL/176/2002/1 Vol. 2]