Cosmetics Product Notification
(Commonly known as Cosmetics Product Registration)
Cosmetics products are regulated under the Control of Drugs and Cosmetics Regulation 1984, which were promulgated under the Sale of Drugs Act 1952.
Under the Control of Drugs and Cosmetics Regulation 1984, Regulation 18A (1): No person shall manufacture, sell, supply, import, possesses any cosmetics unless the cosmetic is a notified cosmetic. It is an offence for anyone to conduct such activities without prior notification to the Director of Pharmaceutical Services (known as DPS)
For more info: Guidelines on Cosmetics Product Registration
Quest3+ Membership Application
(Register USB token)
The QUEST 3+ system has been fully utilized from January 2017 for the purpose of registration of medicines and cosmetics and licensing products in Malaysia. Let us help you with your membership application.
A locally registered company may manufacture or import cosmetic product(s) which have not been notified for the abovementioned purposes subject to written approval by the Director of Pharmaceutical Services (known as DPS).
For more info: Read More on Notification Exemption
Certificate of Free Sale
(Usually for exports)
A Certificate of Free Sale (CFS) serves as document which states that the product can be freely sold in Malaysia. The certificate is not a mandatory requirement. As such, it will only be issued by the National Pharmaceutical Regulatory Agency (NPRA) upon request.
Post Market Surveillance
(Assistance on product information file preparation & audit)
When your products are notified or registered with NPRA, the process of monitoring and screening of your product information is constantly carried out by NPRA to ensure the safety and quality of the products sold in Malaysia. Ensuring compliance is often easier said than done, that’s why we are ready to render our services to you whenever a request is made.
For more info: What is Post Market Surveillance
(General, Functional (Medium) & Disease Risk Reduction (High))
A Health Supplement (HS) means any product that is used to supplement a diet and to maintain, enhance and improve the health function of human body. It is presented in small unit dosage forms (to be administered) such as capsules, tablets, powder, liquids and shall not include any sterile preparations (i.e. injectables, eyedrops).
Example(s): Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics and other bioactive substances, either derived from natural sources, including animal, mineral and botanical materials in the form of extracts, isolates, concentrates, metabolite; or synthetic sources of ingredients mentioned above which may only be used where the safety of these has been proven.
For more info: Guideline On Registration Of Health Supplements
Any product used in the practice of indigenous medicine, in which the drug consist solely of one or more naturally occurring substances of a plant, animal or mineral, of parts thereof, in the unextracted or crude extract form, and a homeopathic medicine. It shall not include any sterile preparation, vaccines, any substance derived human parts, any isolated and characterized chemical substances.
For more info: Guideline on Natural Products
Ready to Register Your Products?
Click here to learn more about the steps and process