Medicines (Good Manufacturing Practice Certificate — Cosmetic Products) Regulations 2002

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Published in Subsidiary Legislation Supplement
on 04 Oct 2002

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No. S 537

Medicines Act

(Chapter 176)

Medicines (Good Manufacturing
Practice Certificate — Cosmetic Products) Regulations 2002

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 (Good Manufacturing Practice Certificate — Cosmetic Products) Regulations 2002 and shall come into operation on 1st November 2002.

Definitions

2. In these Regulations —

“cosmetic product” has the same meaning as in the Medicines (Cosmetic Products) (Specification and Prohibition) Order (O 16);

“Good Manufacturing Practice Certificate” or “GMP Certificate” means a certificate relating to the manufacture of a cosmetic product attesting to its conformity with a Good Manufacturing Practice Standard;

“Good Manufacturing Practice Standard” means the Health Sciences Authority GMP Guidelines for Manufacturers of Cosmetic Products.

Application for GMP Certificate

3.—(1) For the purposes of section 22 of the Act, an application for a GMP Certificate shall be made to the licensing authority in such form and manner as the licensing authority may require.

(2) Upon receipt of an application under paragraph (1), the licensing authority may, upon assessment of satisfactory conformity with a Good Manufacturing Practice Standard, issue a GMP Certificate to the manufacturer of a cosmetic product, subject to such terms and conditions as the licensing authority thinks fit.

(3) Every GMP Certificate issued under paragraph (2) shall be valid for a period not exceeding 3 years from the date of the certificate.

Fees

4.—(1) The fees payable for a GMP Certificate shall be as follows:

(a) on application for a GMP Certificate

—

$4,000;

(b) for each additional GMP Certificate which does not require further assessment of conformity with any Good Manufacturing Practice Standard

—

$200.

(2) No refund shall be made in respect of any fee paid under paragraph (1).

Made this 9th day of September 2002.

MOSES LEE

Permanent Secretary,
Ministry of Health,
Singapore.

[CPA(MQA) 78:01/2; AG/LEG/SL/176/2002/1 Vol. 1]