Medicines (Good Manufacturing Practice Certificate — Cosmetic Products) Regulations

Status:

Revised Edition
published on 31 Jan 2003

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Medicines Act

(Chapter 176, Section 74)

Medicines (Good Manufacturing Practice Certificate — Cosmetic Products) Regulations

Rg 15

G.N. No. S 537/2002

REVISED EDITION 2003

(31st January 2003)

[1st November 2002]

Citation

1. These Regulations may be cited as the Medicines (Good Manufacturing Practice Certificate — Cosmetic Products) Regulations.

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; and

(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).