In Malaysia, health supplement refers to any product used to supplement a diet and to maintain and improve the health function of the human body. It is in small unit dosage forms (to be administered) such as capsules, tablets, powder, as well as liquids and shall not include any sterile preparations (e.g., eyedrops). It may contain one or more of the following combinations:
Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, or other bioactive substances;
Substances derived from natural sources, including animal, mineral, and botanical materials in the forms of extracts, isolates, concentrates, or metabolite;
Synthetic sources of ingredients mentioned in 1 and 2, which may only be used where the safety of these has been proven.
Notes: Health supplements are supervised as medicinal products in Malaysia. Since many nutraceuticals and so-called health food, termed "food-drug interphase (FDI) products" by Malaysian authority, may fall under the food or drug category, it is important to figure out the classification of the product as per Product Classification Guideline (Classification Between Food and Drug) before exportation.
2. Competent authority
National Pharmaceutical Regulatory Agency (NPRA) of the Ministry of Health, formerly known as the National Pharmaceutical Control Bureau (NPCB)
Malaysia Department of Islamic Development (Jabatan Kemajuan Islam Malaysia, JAKIM)
Halal Certification (voluntary) (Read more at Malaysian Halal Food Regulation)
Royal Malaysian Customs Department
3. Market access approval
3.1 Product registration
Submit product registration via QUEST 3+ system. (Read more at QUEST User Manual)
To finish the product registration, applicants shall prepare the certificates mentioned in “Pre-submission of Application (Preparation)” in advance.
Every registered drug is given a registration number, which must be printed on its label or package. The registration is valid for 5 years.
3.2 Enterprise licensing
According to the Controls of Drugs and Cosmetics Regulations 1984, any company that wants to manufacture, import or wholesale any registered products need to have Manufacturer's License, Import License or Wholesale License. License application shall be submitted online through the QUEST 3+ system mentioned in 3.1.
4. Product compliance
Applicants may read Drug Registration Guidance Document (DRGD), especially Appendix 6: Guideline on Registration of Health Supplements, for the product compliance requirements for health supplements. DRGD shall be read in conjunction with current laws and regulations together with other relevant legislations, which include but are not limited to the following:
Sale of Drugs Act 1952;
Control of Drugs and Cosmetics Regulations 1984;
Dangerous Drugs Act 1952;
Poisons Act 1952;
Medicines (Advertisement & Sale) Act 1956;
Wildlife Conservation Act 2010 (Laws of Malaysia Act 716);
International Trade in Endangered Species Act 2008 (Act 686).
Appendix 6 of the DRGD specifies the following content:
Definition of health supplement
Requirements for active ingredients
Maximum daily levels of vitamins and minerals for adults allowed in health supplements
Health supplement claims
Specific dossier requirements for the registration of health supplements
Administrative data and product information requirements (including product particulars, product formula, particulars of packing, labeling requirements, etc.)