Health Supplements

Health Supplements

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). It may contain one or more, or the following combination: 

  1. Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, and other bioactive substances;
  2. Substances derived from *natural sources, including animal, mineral and botanical materials in the forms of extracts, isolates, concentrates, metabolite;
  • Synthetic sources of ingredients mentioned in (i) and (ii) may only be used where the safety of these has been proven.

For details, please refer to Appendix 4: Guideline On Registration Of Health Supplements 

Recent Updates, Directives & Circulars


  • Recent Updates for Guidelines, Circulars, Directives, FAQ & Announcements for Health Supplement
  • Directives & Circulars Related to Health Supplement

Product Registration Process

Step I : Preparation

Product classification, Token Configuration, Payment Mode, Patent and Data Exclusivity status and Ensure key documents availability.

Pre-submission of Application (Preparation)

Step I : Preparation

Step 2 : Submission

Key-in, upload documents and submit your application (Part I, Part II, Part III & Part IV)

Product Validation, Part I, Part II, Part III & Part IV

Step 2 : Submission

Step 3 : Regulatory Outcome

Evaluation of Application & Drug Control Authority (DCA) decision.

Evaluation of Application & Drug Control Authority (DCA) decision.

Step 3 : Regulatory Outcome

Step 4 : Post-registration Process

Maintenance of Registration, Withdrawal of Product Registration, Amendment to the particulars of the product, Post marketing activities

Maintenance of Registration, Withdrawal of Product Registration, Amendment to the particulars of the product, Post marketing activities

Step 4 : Post-registration Process

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

DISCLAIMER

The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

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  • Last Modified: Friday 18 January 2019, 17:07:22.
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