Medicines (Licensing, Standard Provisions and Fees) (Amendment No. 5) Regulations 2005

Status:

Published in Subsidiary Legislation Supplement
on 20 Dec 2005

No. S 821

Medicines Act

(Chapter 176)

Medicines (Licensing, Standard Provisions and Fees) (Amendment No. 5) 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. 5) Regulations 2005 and shall come into operation on 1st January 2006.

Amendment of Fifth Schedule

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

(a)

by deleting sub-paragraph (b) of paragraph (1) of item 1 in Part I and substituting the following sub-paragraph:

“

(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

”;

(b)

by deleting “$60” in paragraph (2)(b) of item 1 in Part I and substituting “$100”;

(c)

by deleting “$20” in paragraph (3)(b) of item 1 in Part I and substituting “$100”;

(d)

by deleting “$35” in paragraph (2)(a)(ii) of item 2 in Part I and substituting “$150”;

(e)

by deleting paragraph (3) of item 2 in Part I and substituting the following paragraph:

“

(3) Application to amend a licence —

(a) with site inspection

$150

(b) without site inspection

$50

”;

(f)

by deleting “$95” in paragraph (2)(b) of item 3 in Part I and substituting “$200”;

(g)

by deleting paragraph (3) of item 3 in Part I and substituting the following paragraph:

“

(3) Application to amend a licence —

(a) with site inspection

$150

(b) without site inspection

$50

”;

(h)

by deleting sub-paragraph (b) of paragraph (2) of item 4 in Part I and substituting the following sub-paragraph:

“

(b) each subsequent year for —

(i) a manufacturer of external preparations

$750

(ii) a manufacturer of oral preparations

$750

(iii) a manufacturer of contact lens solutions

$750

(iv) a manufacturer of external and oral preparations

$1,000

(v) a manufacturer of sterile preparations or other types of dosage forms, or dosage form combinations other than the above

$1,500

(vi) a primary assembler

$500

(vii) a secondary assembler

$300

”;

(i)

by deleting paragraph (3) of item 4 in Part I and substituting the following paragraph:

“

(3) Application to amend a licence —

(a) with site inspection (for manufacturer)

$500

(b) without site inspection (for assembler)

$250

$50

”;

(j)

by deleting sub-paragraph (b) of paragraph (2) of item 3 in Part II and substituting the following sub-paragraph:

“

(b) each subsequent year for —

(i) a manufacturer of external preparations

$750

(ii) a manufacturer of oral preparations

$750

(iii) a manufacturer of external and oral preparations

$1,000

(iv) a primary assembler

$500

(v) a secondary assembler

$300

”; and

(k)

by deleting paragraph (3) of item 3 in Part II and substituting the following paragraph:

“

(3) Application to amend a licence —

(a) with site inspection (for manufacturer)

$500

(b) with site inspection (for assembler)

$250

$50

”.

[G.N. Nos. S 309/2001; S 641/2002; S 621/2003; S 384/2004; S416/2005; S 499/2005; S 558/2005; S 681/2005]

Made this 9th day of December 2005.

YONG YING-I

Permanent Secretary,
Ministry of Health,
Singapore.

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

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