Food Compliance
Intelligence & Solutions
Malaysian Health Supplement Regulation
Nov 25, 2022
Lennie Tao
Pedia Details Reference Our Service Read More
CONTENTS

1. Definition

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:

  1. Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, or other bioactive substances;

  2. Substances derived from natural sources, including animal, mineral, and botanical materials in the forms of extracts, isolates, concentrates, or metabolite;

  3. 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

Competent authority

Responsibility

National Pharmaceutical Regulatory Agency (NPRA) of the Ministry of Health, formerly known as the National Pharmaceutical Control Bureau (NPCB)

  • Assurance of the safety, efficacy, and quality of all registered pharmaceutical products, including health supplements and natural products like herbs

  • Health supplement registration

  • Licensing of   premises for importers, manufacturers, and wholesalers

  • Post-market surveillance, monitoring of Adverse Drug Reactions (ADR), and investigation of complaints

Malaysia Department of Islamic Development (Jabatan Kemajuan Islam Malaysia, JAKIM)

Halal Certification (voluntary) (Read more at Malaysian Halal Food Regulation)

Royal Malaysian Customs Department

Customs declaration

3. Market access approval

3.1 Product registration

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.)

* Global Food Compliance Service

We provide various market entry services to help stakeholders better understand exporting requirements, establish business and secure a competitive place to facilitate trade development.

 Covered Countries

China, Thailand, Vietnam, Singapore, Malaysia, Philippines, Indonesia, Japan, South Korea, United States, European Union, Australia, New Zealand etc.

Our Services

  • Food Ingredient Review

  • Label Review

  • Product Registration

  • Regulatory Consultation

  • Monitoring, Training and customized report

Please feel free to contact us via food@chemlinked.com if you need any help.

User Guide