Comment

The introduction of a voluntary notification initiative affirms the HSA's shift towards a more comprehensive regulatory regime with regard to health supplements and traditional medicines.

Through participating in this initiative, companies can demonstrate that their products are compliant with the necessary safety and quality standards, which may, in turn, help build consumer confidence.

In more detail

Presently, health supplements and traditional medicines generally do not require product registration.

The Government’s launch of the voluntary notification initiative and establishment of this local database will therefore serve as a helpful tool to safeguard consumers. Consumers will be able to access a database of safe and compliant health products, and will also enable better traceability of such products by the HSA.

The initiative will be rolled out in phases from 1 August 2022. To start, the HSA will accept voluntary notification for commonly purchased products and products at higher risk of adulteration. Such products include (i) weight loss; (ii) pain relief; (iii) male vitality enhancement; and (iv) vitamin and mineral supplements. More product categories will be included in the subsequent phases of this initiative.

Notification process and timeline

Product notifications must be submitted by a locally registered company with the Singapore Accounting and Corporate Regulatory Authority.

The notification process involves the following steps:

• Notification submission
• Submission screening and verification
• Notification outcome
• Post-notification changes

The HSA retains the discretion to refuse the notification of products that are not compliant with HSA's regulatory requirements, and to remove non-compliant products from the list of notified products. Companies and consumers should also note that the acceptance of product notifications does not mean that the HSA endorses the products.

Companies are responsible for ensuring the products' quality and safety even after the products are placed on the market post-notification. If there are any changes in the product information to the notified product, companies are required to notify the HSA one month before the product with the intended change is supplied in the market.

Documents required

Companies have to send the following documents to the HSA after submitting the abovementioned notification form:

• Copy of the submitted form
• Manufacturer's licence / certification
• Certificate of Analysis (including appropriate test parameters, their specification and references)
• Final artwork or product label (including the location of batch number and expiry date)
• Product leaflet
• Laboratory test report for toxic heavy metal and microbial limits (including method reference)
• Laboratory test report for poisons screening
• Transmissible Spongiform Encephalopathy (TSE) undertaking form (if applicable)
• Undertaking Form for Website Address or QR Code on Packaging Materials (if applicable)
• Checklist of documentary requirements for voluntary notification of complementary health products (Appendix 2 of Guidelines on the Notification Process and Requirements)

To facilitate the implementation of the voluntary notification initiative, the HSA has published a set of guidelines detailing the testing requirements of health supplements and traditional medicines.

© 2022 Baker & McKenzie.Wong & Leow. All rights reserved. Baker & McKenzie.Wong & Leow is incorporated with limited liability and is a member firm of Baker & McKenzie International, a global law firm with member law firms around the world. In accordance with the common terminology used in professional service organizations, reference to a "principal" means a person who is a partner, or equivalent, in such a law firm. Similarly, reference to an "office" means an office of any such law firm. This may qualify as "Attorney Advertising" requiring notice in some jurisdictions. Prior results do not guarantee a similar outcome.