Regulatory Guidelines and Standards
Regulatory Control of Cosmetics Products
Since 1996, HSA has put in place a framework for the regulation of cosmetic products in order to address safety concerns and protect public health.
Legislation
The legislation governing the control of cosmetic products under the Medicines Act comprise:
- The Medicines (Cosmetic Products) (Specification and Prohibition) Order and its amendments
- The Medicines (Cosmetic Products) (Licensing) Regulations 1996
- The Medicines (Cosmetic Products) (Labelling) Regulations 1996
- The Medicines (Good Manufacturing Practice Certificate – Cosmetic Products)
Under the Medicines Act, all local manufacturing facilities engage in the manufacture or assembly of Category I cosmetic product are required to be licensed by Health Sciences Authority before they can manufacture or assemble cosmetic products for sale and supply.
Applicants for a manufacturer's licence for Category I cosmetic product should submit an online application form via PRISM.
The GMP unit of Manufacturing and Quality Audit Division (MQA) in Health Sciences Authority is responsible for the audit and licensing of manufacturers and assemblers of cosmetic products in accordance with current relevant Good Manufacturing Practice (GMP) standard. The manufacturing facilities will be assessed and audited for compliance with the HSA GMP Guidelines for Manufacturers of Cosmetic Products prior to the issuance of a manufacturer's licence.
Health Sciences Authority GMP Guidelines for Manufacturers of Cosmetic Products
For more information on the HSA GMP Guidelines for Manufacturers of Cosmetic Products, which is equivalent to and extracted from the ASEAN Guidelines for Cosmetic Good Manufacturing Practice, please click here.
The HSA GMP Guidelines for Manufacturers of Cosmetic Products can be downloaded from here.
With the joint effort of the regulatory authority and the industry of the ASEAN member countries, a set of 13 training modules on the ASEAN cosmetic GMP have been developed to provide a consistent interpretation and implementation of the GMP Guidelines in ASEAN. The training modules can be obtained from the ASEAN official website: http://www.aseansec.org/18514.htm. The information may also be requested from the local cosmetic association.



