No. S 648
Medicines Act
(Chapter 176)
Medicines (Licensing, Standard Provisions and Fees) (Amendment) Regulations 2006
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 2006 and shall come into operation on 1st December 2006.
Deletion and substitution of Fifth Schedule
2.  The Fifth Schedule to the Medicines (Licensing, Standard Provisions and Fees) Regulations (Rg 6) 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, in respect of —
 
 
(a) the initial screening#
 
$250
(b) the evaluation* for —
 
 
(i) an innovator product containing new chemical or biological entity, new combination, new dosage form or new route of administration — single-strength product or first product in a series of products of different strengths
 
$2,000
(ii) an innovator product containing new chemical or biological entity, new combination, new dosage form or new route of administration — subsequent product in a series of products of different strengths
 
$1,000
(iii) a generic drug product — single-strength product or first product in a series of products of different strengths
 
$500
(iv) a generic drug product — subsequent product in a series of products of different strengths
 
$300
(2)  Licence for —
 
 
(a) the first year
 
No charge
(b) each subsequent year
 
$100
(3)  Application to amend a licence —
 
 
(a) to make changes to product specifications relating to indications, dosage recommendations or patient groups, in respect of —
 
 
(i) the initial screening#
 
$250
(ii) the evaluation* for a single-strength product or the first product in a series of products of different strengths
 
$1,000
(iii) the evaluation* for a subsequent product in a series of products of different strengths
 
$200
(b) to make any other changes to product specifications
 
$100
 
 
 
2.  IMPORT LICENCE
 
 
(1) Application for a licence for —
 
 
(a) importation authorised by product licence holder
 
$500
(b) importation not authorised by product licence holder — per consignment imported
 
$250
(2) Licence for —
 
 
(a) importation authorised by product licence holder for —
 
 
(i) the first year
 
No charge
(ii) each subsequent year
 
$500
(b) importation not authorised by product licence holder — per consignment imported
 
No charge
(3) Application to amend a licence —
 
 
(a) with site inspection
 
$300
(b) without site inspection
 
$50
 
 
 
3.  WHOLESALE DEALER’S LICENCE
 
 
(1) Application for a licence
 
$500
(2) Licence for —
 
 
(a) the first year
 
No charge
(b) each subsequent year
 
$500
(3) Application to amend a licence —
 
 
(a) with site inspection
 
$300
(b) without site inspection
 
$50
 
 
 
4.  MANUFACTURER’S LICENCE
 
 
(1) Application for a licence for —
 
 
(a) manufacture of external preparations
 
$1,500
(b) manufacture of oral preparations
 
$1,500
(c) manufacture of contact lens solutions
 
$1,500
(d) manufacture of external and oral preparations
 
$2,000
(e) manufacture of sterile preparations or other types of dosage forms, or dosage form combinations other than the above
 
$3,000
(f) primary assembly
 
$1,000
(g) secondary assembly
 
$600
(2) Licence for —
 
 
(a) the first year
 
No charge
(b) each subsequent year for —
 
 
(i) a manufacturer of external preparations
 
$1,500
(ii) a manufacturer of oral preparations
 
$1,500
(iii) a manufacturer of contact lens solutions
 
$1,500
(iv) a manufacturer of external and oral preparations
 
$2,000
(v) a manufacturer of sterile preparations or other types of dosage forms, or dosage form combinations other than the above
 
$3,000
(vi) a primary assembler
 
$1,000
(vii) 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
 
 
 
5.  CERTIFICATES AND DOCUMENTS
(NON-MANDATORY)
 
 
(1) a Certificate to Export a Medicinal Product
 
$100
(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
 
$100
Part II
CHINESE PROPRIETARY MEDICINEs
1.  IMPORT LICENCE
 
 
(1) Application for a licence
 
$500
(2) Licence for —
 
 
(a) the first year
 
No charge
(b) each subsequent year
 
$500
(3) Application to amend a licence —
 
 
(a) with site inspection
 
$300
(b) without site inspection
 
$50
 
 
 
2.  WHOLESALE DEALER’S LICENCE
 
 
(1) Application for a licence
 
$500
(2) Licence for —
 
 
(a) the first year
 
No charge
(b) each subsequent year
 
$500
(3) Application to amend a licence —
 
 
(a) with site inspection
 
$300
(b) without site inspection
 
$50
 
 
 
3.  MANUFACTURER’S LICENCE
 
 
(1) Application for a licence for —
 
 
(a) manufacture of external preparations
 
$1,500
(b) manufacture of oral preparations
 
$1,500
(c) manufacture of external and oral preparations
 
$2,000
(d) primary assembly
 
$1,000
(e) secondary assembly
 
$600
(2) Licence for —
 
 
(a) the first year
 
No charge
(b) each subsequent year for —
 
 
(i) a manufacturer of external preparations
 
$1,500
(ii) a manufacturer of oral preparations
 
$1,500
(iii) a manufacturer of external and oral preparations
 
$2,000
(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
 
 
 
4.  CERTIFICATES (NON-MANDATORY)
 
 
(1) a Certificate to Export a Chinese Proprietary Medicine
 
$100.
 
 
 
* Fees are payable upon acceptance of application.
 
 
# Fees are payable upon submission of application.”.
 
 
[G.N. Nos. S 309/2001; S 641/2001; S 621/2003; S 384/2004; S416/2005; S 499/2005; S 558/2005; S 681/2005; S 821/2005]

Made this 28th day of November 2006.

YONG YING-I
Permanent Secretary,
Ministry of Health,
Singapore.
[HSA 700:69/01-000; AG/LEG/SL/176/2002/1 Vol. 4]
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