Medicines (Licensing, Standard Provisions and Fees) (Amendment No. 3) Regulations 2005

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Published in Subsidiary Legislation Supplement
on 25 Aug 2005

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No. S 558

Medicines Act

(Chapter 176)

Medicines (Licensing, Standard Provisions and Fees) (Amendment No. 3) 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 No. 3) Regulations 2005 and shall come into operation on 1st September 2005.

Amendment of Fifth Schedule

2. Part I of the Fifth Schedule to the Medicines (Licensing, Standard Provisions and Fees) Regulations (Rg 6) is amended —

(a)

by deleting paragraph (1) of item 1 and substituting the following paragraph:

“

(1) Application for a licence, in respect of —

(a) the initial screening#

$250

(b) the evaluation*

$240

”;

(b)

by deleting paragraph (3) of item 1 and substituting the following paragraph:

“

(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

$20

”; and

(c)

by inserting, immediately after the existing footnote, the following footnote:

“#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]

Made this 18th day of August 2005.

YONG YING-I

Permanent Secretary,
Ministry of Health,
Singapore.

[HSA 700:69/01-000; AG/LEG/SL/176/2002/1 Vol. 3]