Malaysia’s Drug Control Authority (DCA), which was established under the Control of Drugs and Cosmetics Regulations 1984, is a government authority that ensures the safety, effectiveness and quality of cosmetic products marketed in Malaysia. The DCA is responsible for the registration and licensing of all pharmaceutical and cosmetic products, monitoring the quality of registered products, and Adverse Drug Reaction Monitoring. The National Pharmaceutical Control Bureau (NPCB), which is a secretariat of the DCA, evaluates and assesses the safety of cosmetic products for the Malaysian market.
According to the Control of Drugs and Cosmetic Regulations 1984, all cosmetic products must be registered before they can be imported, distributed, manufactured, or used in Malaysia. Cosmetic products are grouped into two distinct categories: Category I includes products that might be absorbed through the skin or mucous membrane, while Category II includes all other cosmetic products not listed under Category I. Domestically manufactured products can be registered directly by the local manufacturing firm. Imported products must be registered by a local firm or distributor that has written authorization to hold the registration certificate and supervise all subsequent registration issues.
Applications for cosmetic product registration are available online at www.health21.com.my/crm/, and all materials must be submitted in English or Bahasa Malaysia. The submission requirements for the online application forms are as follows. General information, including applicant information, full formula, specifications, cautions or warnings, instructions, storage conditions, and the label and bar code are required. The ingredients, which must not include any active medicinal or therapeutic ingredients, must be listed during registration. Localized labeling and product packaging information, which must comply with the new Malaysian standards released in November, will also be detailed during the registration process. Finally, the product must not make any claims that it will alleviate, cure, or treat a disease or its symptoms, nor can the product claim to prevent or protect one from disease.
In addition to the application forms, several other documents are also required. The manufacturer (if different from the applicant) must write a letter of authorization, designating the applicant to act on their behalf for all the listed products. A Certificate of Free Sale and a certification of observance of Good Manufacturing Practice are also required from the health authorities in the product’s country of origin.