Singapore: Guide - Voluntary Notification System for Health Supplements & Traditional Medicine

On 1 August 2022, the Health Sciences Authority of Singapore (HSA) has launched Voluntary Notification System (VNS). Voluntary Notification System main purpose is to provide information for consumers to refer to before purchasing any health products focusing on health supplements (HS) and traditional medicine (TM) supplied in Singapore. The genuine local database also can be used to track product information if there are any safety or quality issues that occur. Updated until February 2023 by HSA, more than 100 companies have registered in Voluntary Notification System.

VNS participant companies must provide accurate information and genuine documentation to prove the products are safe and meet up the standard guideline to be published on the HSA database. Companies should be responsible for product safety and quality and compulsory to update HSA for any amendment or changes that occur during its life cycle at least 1 month prior to the supply of the product in the market.

HSA has provided details regulatory guidelines and requirements for the notification process covering both health supplements (HS) and traditional medicine (TM). There are 4 notification stages to be involved and each stage is crucial. Any notification submission that does not fulfill the standard requirement will not be published on HSA database.

Notification Process Stages

1. Stage 1: Notification Submission

First and foremost, there are 2 steps required for the submission which are online FormSG notification form submission and submission of required documents:

• FormSG Notification Form Submission

Company must be registered and based in Singapore and submission can only be made via FormSG. It is

compulsory for companies to register on Corppass to submit form in FormSG.

• Submission required documents

After submission on FormSG, the company will receive a copy of FormSG Notification Form and Response ID. All the required documents must be submitted within 2 working days of submitting FormSG Notification Form via email. Documents must be submitted in soft copies and the copies must be certified by authorized bodies. Companies should attach together the completed checklist to prove that all document sets are complete.

2. Stage 2: Submission Screening and Verification

Screening submission is a process of document checking to ensure all documents are complete for verification. Once the submission has been done via FormSG, the company will receive a receipt of the required documents by HSA and the submission date and screening will be taken starting from the receipt of the required documents received.

For any incomplete documents or any query that exists during the screening, HSA will send Input Request via email to the company. The stop clock will start from the Input Request sent and will end upon the receipt of complete.

The total number of Input requests during the screening stage is limited to three times. Companies have one month period to respond to the Input Request. If fail to respond to the Input Request, the notification submission is rejected and an email will be sent for closed submission. Companies have to process new submissions.

Once the companies pass through submission screening, they will automatically proceed for verification. The rules during verification are the same rules applied during the submission screening stage. Companies may inform HSA if more time is needed to respond to Input Requests. If companies fail to obey the specified response deadline, notification submission will be closed.

3. Stage 3 Notification Outcome

Once companies manage to pass through all three stages before, there will be only 2 possible outcomes notified by HSA which are “Notified” if all the notification requirement for safety and quality is completed or “Rejected” due to the failure of responding to the Input Requests or submission cannot satisfy the notification requirements. HSA will provide notification outcomes within 60 working days.

4. Stage 4: Post-Notification Amendments

Companies must have to be responsible for the quality and safety of the products after being notified and published under VNS. If there is any amendment or changes made to the product, companies must inform HSA 1 month before products are supplied to the market. Any minor amendments would not require HSA approval before implementation, while for major amendments, companies must have HSA approval before implementation. Companies may refer HSA website for the details list of required supporting documents for amendment submission.

Any changes on the responsible company for the notified product, product name or brand name, product dosage form and active ingredient and/or quantity in the notified product will require new notification submission.

Source: Health of Science Authority (HSA)

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