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In brief

To facilitate better traceability and follow-up actions in the event of safety or quality issues, the Health Science Authority (HSA) is launching a voluntary notification initiative for health supplements and traditional medicines. From 1 August 2022, companies may submit documents regarding their products to the HSA. If the products meet the necessary safety and quality standards and labelling requirements, they will be published on the HSA’s database, which patients and consumers can refer to when considering suitable health supplements and traditional medicines.


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:

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.

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Author

Ren Jun Lim is a principal with Baker McKenzie Wong & Leow. He represents local and international clients in both contentious and non-contentious intellectual property matters. He also advises on a full range of healthcare, as well as consumer goods-related legal and regulatory issues. Ren Jun co-leads Baker McKenzie Wong & Leow's Healthcare as well as Consumer Goods & Retail industry groups. He sits on the Law Society of Singapore IP Committee and on the Executive Committee of the Association of Information Security Professionals. He is also a member of the Vaccines Working Group, Singapore Association of Pharmaceutical Industries, a member of the International Trademark Association, as well as a member of the Regulatory Affairs Professionals Association. Ren Jun is ranked in the Silver tier for Individuals: Enforcement and Litigation and Individuals: Prosecution and Strategy, and a recommended lawyer for Individuals: Transactions by WTR 1000, 2020. He is also listed in Asia IP's Best 50 IP Expert, 2020, recognised as a Rising Star by Managing IP: IP Stars, 2019 and one of Singapore's 70 most influential lawyers aged 40 and under by Singapore Business Review, 2016. Ren Jun was acknowledged by WTR 1000 as a "trademark connoisseur who boasts supplementary knowledge of regulatory issues in the consumer products industry." He was also commended by clients for being "very responsive to enquiries and with a keen eye for detail, he is extremely hands-on. His meticulous and in-depth approach to strategising is key to the excellent outcomes we enjoy."

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