Health supplements in Singapore are under the unified regulation of the Health Sciences Authority (HSA). Singapore adopts a voluntary notification scheme for health supplement market access. Customs and other relevant regulatory authorities conduct random spot checks on product labels, ingredients and other related information at the point of importation or during the post-marketing phase.
Official Website of the Regulatory Authority: https://www.hsa.gov.sg/health-supplements/overview
Database Portal: https://www.hsa.gov.sg/other-regulations/vns-list/#3df243830bbb6dc1635359a6ea2d8729
Poisons Act (Chapter 234) and the Poisons Rules
Misuse of Drugs Act (Chapter 185) and its subsidiary regulations
ASEAN Guiding Principles for Inclusion into or Exclusion from the Negative List of Substances for Health Supplements
1.Definition
A health supplement in Singapore is defined as a product used to supplement the diet and to support, maintain, enhance and improve the healthy functions of the human body. It shall not be presented in injectable or sterile forms, nor shall it serve as a meal replacement or the sole source of dietary intake.
2.Core Classification Criteria
① Products intended for medicinal purposes are classified as medicinal products and regulated by the HSA.
② Products intended for dietary supplementation, presented in pharmaceutical dosage forms such as capsules, tablets or softgels with defined unit doses and recommended daily intake, are classified as health supplements and regulated by the HSA.
③ Products that form part of the everyday diet, presented in conventional food forms without specified dosage limits, are classified as general food products and regulated by the Singapore Food Agency (SFA).
① Full information of the local importer based in Singapore;
② Certificate of Analysis (COA) for finished products and product technical specifications;
③ Final version of product label artwork;
④ Complete ingredient formulation list of the product;
⑤ Test reports for heavy metals and microbial limits of the product;
⑥ Description of the product manufacturing process.
English
Manufacturer’s license / certificate
Description of manufacturing process
Finished product specifications
Certificate of Analysis (COA)
Final product label / artwork (indicating the positions of batch number and expiry date)
Product instruction leaflet (if applicable)
Laboratory test reports: heavy metal tests (arsenic, cadmium, lead, mercury), microbial limit tests, adulterant screening, and diethylene glycol / ethylene glycol tests (for oral liquid preparations)
Notification Procedure, Timeline and Official Fees
1.Notification Procedure
Standard procedure: Product classification assessment → Online submission of notification application and full set of documentation → Document screening and information verification by the HSA → Issuance of notification outcome notice
2.Notification Timeline and Official Fees
Official notification processing time: 60 working days
Official notification fee: No official fee is charged by the HSA for health supplement notification.