Health Products (Good Manufacturing Practice Certificate — Cosmetic Products) Regulations 2011

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No. S 543

Health Products Act

(CHAPTER 122D)

Health Products
(Good Manufacturing Practice
Certificate — Cosmetic Products)
Regulations 2011

In exercise of the powers conferred by sections 71 and 72 of the Health Products Act, the the Health Sciences Authority, with the approval of the Minister for Health, hereby makes the following Regulations:

Citation and commencement

1. These Regulations may be cited as the Health Products (Good Manufacturing Practice Certificate — Cosmetic Products) Regulations 2011 and shall come into operation on 3rd October 2011.

Definitions

2. In these Regulations —

“cosmetic product” means a cosmetic product as specified and described in the First Schedule to the Act;

“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 Authority’s GMP Guidelines for Manufacturers of Cosmetic Products as published on the Authority’s Internet website at http://www.hsa.gov.sg and updated from time to time.

Application for GMP Certificate

3.—(1) An application for a GMP Certificate shall be —

(a)	made to the Authority in such form and manner as the Authority may require; and
(b)	accompanied by such particulars, information, documents and samples as the Authority may require.

(2) Upon receiving an application under paragraph (1), the Authority may, if it assesses that the manufacture of the cosmetic product to which the application relates satisfactorily conforms with a Good Manufacturing Practice Standard, issue a GMP Certificate to the manufacturer of the cosmetic product, subject to such terms and conditions as the 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 assessment referred to in paragraph (2).

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).

Made this 16th day of September 2011.

EDISON LIU

Chairman,
Health Sciences Authority,
Singapore

[HSA (HRPG) 401:04/01-000; AG/LLRD/SL/122D/2010/7 Vol. 1]

(To be presented to Parliament under section 72(5) of the Health Products Act).

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