Voluntary Notification of Health Supplements and Traditional Medicines

Overview

Dealers may voluntarily notify HSA of the HS, TM, MOB and medicated plasters supplied in Singapore. Companies must provide HSA with the relevant documents to demonstrate that their products meet the necessary safety and quality standards. For further information on the safety and quality standards, please refer here for HS, TM and MOB and medicated plasters, as applicable. Only products that are compliant with the safety and quality standards will be published here.

Who can submit a notification

You must be a locally registered company with the Accounting and Corporate Regulatory Authority (ACRA) to submit a product notification.

To check if the ingredients in your product are in the voluntary product notification pre-approved list of ingredients, you may use the search tool here.

Ingredients in the pre-approved list may have specific conditions of use, such as maximum daily dose limits or labelling specifications. More information can be found in the Guidelines on Prohibited and Restricted Ingredients in Health Supplements and Traditional Medicines.

Documents required 

Dealers are required to use this form to submit your notification.

To complete the notification submission, the following documents must be submitted as attachments in the notification form.

1. Manufacturer's licence/certification 

2. Description of manufacturing process 

3. Finished product specifications

4. Certificate of Analysis (including appropriate test parameters, their specification and references)

5. Final artwork or product label (including the location of batch number and expiry date)

6. Product leaflet (if any)

7. Laboratory test report for toxic heavy metal and microbial limits (including method reference)*

8. Laboratory test report for adulterants screening (depending on type of product)*

9. Laboratory test report for diethylene glycol (DEG) and ethylene glycol (EG) in starting material (if applicable)

10. Laboratory test report for DEG and EG in finished product (if applicable) 

11. Transmissible Spongiform Encephalopathy (TSE) undertaking form (if applicable)

12. Undertaking Form for Website Address or QR Code on Packaging Materials (if applicable)

13. Product linkage form (if applicable)

* Please refer to the Guidelines for Testing Requirements of TM and HS for more information.

Note: In addition to the above items, we may request for other information relevant to your submission.

Product notification fees

You do not need to pay a fee.

How to submit a notification

A product notification must be accompanied by a complete notification form and the requested declaration or documents demonstrating that product meet the requisite quality and safety standards

• Ensure you have CorpPass before submitting your notification.

• Use this form to submit your notification

Refer to the Guidelines on Notification Process and Requirements for details on the dataset required for product notification.

A list of questions and answers on product notification can be found here.

Please contact HSA at HSA_CHP@hsa.gov.sg should you require further clarifications.

HSA reserves the right, at our discretion, to refuse the notification of products that have non-compliance records or are under investigation by HSA as we have evidence that the dealers appear to be non-compliant with our regulatory requirements. If any product breaches the notification conditions, HSA can remove the product from the list of notified products.

Turn-around-time

The turn-around-time for new product notification submissions is 60 working days, excluding the time taken by you to respond to our request for clarification or additional information (company's stop-clock).

Notification process

The notification process involves a series of steps, as shown below.