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:
- Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, and other bioactive substances;
- 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 : PreparationStep 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 : SubmissionStep 3 : Regulatory Outcome
Evaluation of Application & Drug Control Authority (DCA) decision.
Evaluation of Application & Drug Control Authority (DCA) decision.
Step 3 : Regulatory OutcomeStep 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