Statute Details
- Title: Health Products (Fees) Regulations 2022
- Act Code: HPA2007-S450-2022
- Type: Subsidiary legislation (SL)
- Authorising Act: Health Products Act 2007
- Enacting authority: Health Sciences Authority (HSA), with Minister for Health’s approval
- Commencement: 1 July 2022
- Current version (as provided): Current version as at 27 Mar 2026
- Key provisions (from extract): Sections 1–5; First to Ninth Schedules
- Amendment history (from timeline extract): Amended by S 438/2023 (26 Jun 2023), S 833/2023 (18 Dec 2023, with effect 18/12/2023), S 489/2024 (01 Jul 2024)
What Is This Legislation About?
The Health Products (Fees) Regulations 2022 is a Singapore regulatory instrument that sets out the fees payable to the Health Sciences Authority (HSA) for a wide range of regulatory processes under the Health Products Act 2007 and its related product-specific subsidiary regulations. In practical terms, it tells regulated parties how much they must pay and when they must pay it when applying for approvals, registrations, certificates, notifications, or when HSA evaluates and retains registrations.
Although the Regulations are short in their operative text, they are highly consequential because they operate through nine schedules that attach specific fee amounts to different regulatory pathways. The Regulations also connect to multiple other legal regimes—such as those governing cell, tissue and gene therapy products, clinical research materials, cosmetic products under the ASEAN Cosmetic Directive, medical devices, oral dental gums, therapeutic products, retail pharmacies, and active ingredients.
From a lawyer’s perspective, the Regulations are best understood as a fee architecture: they standardise payment timing rules and provide a discretionary mechanism for waiver or refund, while delegating the actual fee quantum to the schedules. This matters for budgeting, compliance planning, and dispute management (e.g., when a party believes a fee should be waived or refunded).
What Are the Key Provisions?
1. Citation and commencement (Section 1)
Section 1 confirms that the Regulations are the “Health Products (Fees) Regulations 2022” and that they come into operation on 1 July 2022. This is important for determining whether fee obligations apply to applications submitted before or after commencement, and for assessing whether any transitional issues arise where regulatory processes span dates.
2. Definitions and cross-references (Section 2)
Section 2 contains a set of definitions that are heavily cross-referenced to other subsidiary legislation. For example, it defines “CTGT product” by reference to the First Schedule to the Health Products Act 2007, and defines “CRM Regulations”, “MD Regulations”, “TP Regulations”, “AI Regulations”, and others by reference to their respective legal instruments. It also defines “clinical research material” by reference to the Health Products (Clinical Research Materials) Regulations 2016 (“CRM Regulations”).
For practitioners, this drafting technique is not merely technical: it ensures that the fee regime automatically tracks changes in the underlying product categories and regulatory frameworks. When advising clients, counsel should therefore read the fee schedules together with the relevant product-specific regulations to confirm (i) the correct regulatory category and (ii) the correct fee schedule that applies.
3. Fees payable to the Authority (Section 3)
Section 3 is the core “mapping” provision. It states that the fees specified in each schedule are payable to HSA for specified regulatory activities. In summary:
- First Schedule: fees for manufacture, import, supply and registration of CTGT products under the CTGTP Regulations.
- Second Schedule: fees for manufacture, import and supply of clinical research material under the CRM Regulations.
- Third Schedule: fees for submission of a notification under regulation 4 of the CP-ACD Regulations (cosmetic products under the ASEAN Cosmetic Directive).
- Fourth Schedule: fees for an application for a certificate under regulation 3 of the GMPC-CP Regulations (Good Manufacturing Practice Certificate for cosmetic products).
- Fifth Schedule: fees relating to retail pharmacies and supply of certain health products under the LRP Regulations.
- Sixth Schedule: fees for manufacture, import, supply and registration of medical devices under the MD Regulations.
- Seventh Schedule: fees for manufacture, import, supply, registration and advertisement of oral dental gums under the ODG Regulations.
- Eighth Schedule: fees for manufacture, import, supply and registration of therapeutic products under the TP Regulations.
- Ninth Schedule: fees for manufacture, import and supply of active ingredients under the AI Regulations.
This structure is particularly useful for legal review. When a client’s product falls into multiple categories (or when a product’s classification is contested), counsel can use Section 3 to identify which schedule(s) might be triggered. It also clarifies that the fee regime is not limited to “registration” alone; it can cover manufacture, import, supply, notifications, certificates, and advertisement-related approvals.
4. Time for payment of fees (Section 4)
Section 4 provides the timing rules—often the most operationally important aspect of a fee regulation. It distinguishes between different types of fees:
- Application fees: An application fee mentioned in any schedule must be paid when the application is submitted to HSA (Section 4(1)).
- Approval fees for advertisements: For advertisement approvals (including variations and transfers of approval) specified in the Seventh Schedule, the approval fee must be paid when the advertisement application is submitted (Section 4(2)).
- Evaluation fees: For registration of a health product specified in the First, Sixth or Eighth Schedule, an evaluation fee is payable upon HSA’s acceptance of the product for evaluation after initial screening (Section 4(3)).
- Retention fees: For purposes of section 31(a) of the Health Products Act 2007, the prescribed retention fee is specified in the First, Sixth, Seventh and Eighth Schedules and is payable on or before each anniversary of the registration date (Section 4(4)).
These timing rules have direct compliance consequences. For example, failure to pay an application fee at submission may delay processing or render the application non-compliant. Similarly, retention fees are recurring obligations tied to registration anniversaries; missing a retention payment could affect the continued validity of registrations, depending on how the Act and related regulations treat non-payment.
5. Waiver or refund (Section 5)
Section 5 gives HSA discretion to waive or refund the whole or any part of any fee payable or paid under any schedule. The discretion applies “in any particular case or class of cases”.
For practitioners, this provision is a key lever in fee disputes or hardship scenarios. It does not create an automatic entitlement; rather, it provides a legal basis for HSA to grant relief. Counsel should therefore consider whether the client can present facts that fit within any published HSA policies or administrative practice (if any), and should document the basis for requesting waiver/refund—particularly where the fee is significant or where procedural delays occurred outside the applicant’s control.
How Is This Legislation Structured?
The Regulations are structured as follows:
- Section 1: Citation and commencement.
- Section 2: Definitions, including cross-references to multiple product-specific regulations.
- Section 3: Establishes which schedules apply to which regulatory activities and product categories.
- Section 4: Sets out when different categories of fees must be paid (at submission, upon acceptance for evaluation, or annually for retention).
- Section 5: Waiver/refund discretion.
- First to Ninth Schedules: Contain the fee amounts (and likely fee categories) for each regulatory pathway.
Because the operative text relies on the schedules for the actual fee quantum, a practitioner should treat the schedules as integral to legal advice. The schedules determine the financial exposure and the specific fee triggers.
Who Does This Legislation Apply To?
The Regulations apply to persons and entities that engage in regulated activities under the Health Products Act 2007 and its subsidiary product-specific regulations—particularly those seeking HSA regulatory actions that attract fees. This includes manufacturers, importers, suppliers, applicants for certificates and notifications, and (in the relevant schedule) parties involved in retail pharmacy regulation and advertisement approvals for oral dental gums.
In addition, the retention fee provisions apply to holders of registrations for the product categories covered by the relevant schedules (notably CTGT products, medical devices, oral dental gums, and therapeutic products, as reflected in Section 4(4)). Practically, this means ongoing compliance teams must track registration anniversaries and ensure timely payment.
Why Is This Legislation Important?
First, the Regulations provide the legal basis for HSA to charge fees across multiple health product regulatory regimes. For regulated businesses, fees are not discretionary; they are part of the compliance cost of obtaining and maintaining regulatory status. Section 3’s schedule mapping is therefore essential for accurate regulatory budgeting and for avoiding underpayment or misclassification.
Second, the timing rules in Section 4 reduce ambiguity about when payment must occur. This is critical in transactional and operational contexts—such as product launches, importation timelines, and advertisement campaigns—where delays can have commercial consequences. The distinction between payment at submission (application and advertisement approval fees) and payment upon acceptance for evaluation (evaluation fees) affects cash flow and internal workflow planning.
Third, Section 5’s waiver/refund discretion provides a structured route for relief. While not a guarantee, it can be strategically important where a client faces exceptional circumstances, administrative errors, or procedural outcomes that make full payment inequitable. Counsel should consider whether to invoke Section 5 early, supported by evidence, rather than treating fee disputes as purely retrospective.
Related Legislation
- Health Products Act 2007 (authorising Act; including section 31(a) referenced for retention fees)
- Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021 (CTGTP Regulations)
- Health Products (Clinical Research Materials) Regulations 2016 (CRM Regulations)
- Health Products (Cosmetic Products — ASEAN Cosmetic Directive) Regulations 2007 (CP-ACD Regulations)
- Health Products (Good Manufacturing Practice Certificate — Cosmetic Products) Regulations 2011 (GMPC-CP Regulations)
- Health Products (Licensing of Retail Pharmacies) Regulations 2016 (LRP Regulations)
- Health Products (Medical Devices) Regulations 2010 (MD Regulations)
- Health Products (Oral Dental Gums) Regulations 2016 (ODG Regulations)
- Health Products (Therapeutic Products) Regulations 2016 (TP Regulations)
- Health Products (Active Ingredients) Regulations 2023 (AI Regulations)
Source Documents
This article provides an overview of the Health Products (Fees) Regulations 2022 for legal research and educational purposes. It does not constitute legal advice. Readers should consult the official text for authoritative provisions.