Statute Details
- Title: Health Products (Fees) Regulations 2022
- Act Code: HPA2007-S450-2022
- Legislation Type: Subsidiary legislation (SL)
- Authorising Act: Health Products Act 2007
- Enacting Authority: Health Sciences Authority (HSA), with Minister for Health’s approval
- Legal Basis: Powers under section 71 of the Health Products Act 2007
- Citation and Commencement: Comes into operation on 1 July 2022
- Status: Current version as at 27 Mar 2026
- Key Provisions (from extract): Sections 1–5; Schedules 1–9
- Most Relevant Sections:
- Section 2: Definitions (including cross-references to other “Health Products” regulations)
- Section 3: Fees payable to the Authority (mapped to specific regulatory regimes and Schedules)
- Section 4: Timing of payment (when fees must be paid)
- Section 5: Authority’s discretion to waive or refund fees
- Schedules: First to Ninth Schedules (fee tables for different product categories and regulatory processes)
- Notable Amendments (timeline extract): Amended by S 438/2023, S 833/2023 (effective 18/12/2023), and S 489/2024 (effective 01/07/2024)
What Is This Legislation About?
The Health Products (Fees) Regulations 2022 is a Singapore subsidiary legislation instrument that sets out the fees payable to the Health Sciences Authority (HSA) for a range of regulatory activities under the broader Health Products Act 2007 framework. In practical terms, it tells regulated parties how much they must pay and when they must pay it when applying for approvals, registrations, evaluations, and related processes for health products.
Although the Regulations are short in structure (Sections 1–5 plus fee Schedules), they operate as a “fee backbone” across multiple specialist regulatory regimes. The Regulations do not regulate product safety or licensing requirements themselves; instead, they attach monetary obligations to existing substantive rules found in other sets of regulations (for example, regulations governing cell, tissue and gene therapy products, medical devices, therapeutic products, clinical research materials, cosmetic products under the ASEAN Cosmetic Directive, and active ingredients).
From a lawyer’s perspective, the key value of this instrument is that it provides a procedural cost map for clients: which fee applies to which regulatory step, and the payment timing rules that can affect application validity, processing, and compliance strategy. It also contains an important discretionary mechanism—waiver or refund—that may be relevant in disputes, hardship situations, or exceptional administrative circumstances.
What Are the Key Provisions?
Section 1 (Citation and commencement) confirms the legal identity of the Regulations and that they come into operation on 1 July 2022. This matters for determining which fee schedule applies to applications submitted before versus after commencement, and for assessing whether any later amendments affect ongoing applications or renewals.
Section 2 (Definitions) is primarily a cross-referencing provision. It defines terms by reference to other regulations under the Health Products Act ecosystem. For example, it defines “CTGT product” by reference to the First Schedule to the Act, and it defines multiple regulatory regimes by their own titles (e.g., “CRM Regulations”, “MD Regulations”, “TP Regulations”, “AI Regulations”, and others). This drafting technique is common in Singapore subsidiary legislation: it ensures that the fee instrument stays aligned with the evolving substantive regulatory framework.
Section 3 (Fees payable to Authority) is the core operative provision. It assigns fee obligations to HSA activities and ties them to the relevant Schedules. In summary, the Regulations provide that:
- First Schedule fees apply to manufacture, import, supply and registration of CTGT products under the CTGTP Regulations.
- Second Schedule fees apply to manufacture, import and supply of clinical research material under the CRM Regulations.
- Third Schedule fees apply to submission of a notification under regulation 4 of the CP-ACD Regulations (cosmetic products under the ASEAN Cosmetic Directive).
- Fourth Schedule fees apply to an application for a certificate under regulation 3 of the GMPC-CP Regulations (Good Manufacturing Practice Certificate for cosmetic products).
- Fifth Schedule fees apply to matters relating to retail pharmacies and the supply of certain health products under the LRP Regulations.
- Sixth Schedule fees apply to manufacture, import, supply and registration of medical devices under the MD Regulations.
- Seventh Schedule fees apply to manufacture, import, supply, registration and advertisement of oral dental gums under the ODG Regulations.
- Eighth Schedule fees apply to manufacture, import, supply and registration of therapeutic products under the TP Regulations.
- Ninth Schedule fees apply to manufacture, import and supply of active ingredients under the AI Regulations.
This mapping is crucial for practitioners. It means you cannot treat the Regulations as a single “one-size-fits-all” fee schedule. Instead, you must identify the regulatory regime and the product category first, then locate the corresponding Schedule and fee type.
Section 4 (Time for payment of fees) governs when payment must be made. The timing rules are often as important as the amounts because they can affect whether an application is considered properly submitted or processed. The extract provides four main timing rules:
- Application fees: An application fee mentioned in any Schedule must be paid when the application is submitted to HSA.
- Approval fees for advertisements: For advertisements (including variations or transfer of advertisement approval) specified in the Seventh Schedule, the approval fee must be paid when the advertisement application is submitted.
- Evaluation fees: For registration of a health product specified in the First, Sixth or Eighth Schedules, an evaluation fee is payable upon HSA’s acceptance of the product for evaluation after initial screening.
- Retention fees: For the purposes of section 31(a) of the Act, a “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 5 (Waiver or refund of fees) provides HSA with discretion to waive or refund the whole or any part of any fee payable or paid under any Schedule. This is a practical safety valve. For counsel, it supports arguments for relief in exceptional circumstances (for example, administrative errors, duplicative filings, or other situations where fairness and proportionality may be relevant). However, because the provision is discretionary (“may”), it does not create an automatic entitlement; it is best used as a negotiation or mitigation tool rather than a guaranteed remedy.
How Is This Legislation Structured?
The Regulations are structured in a straightforward hierarchy:
- Part/Section framework: Sections 1–5 set out citation/commencement, definitions, the fee categories (by reference to Schedules), payment timing, and waiver/refund discretion.
- Schedules (First to Ninth): The substantive fee amounts and fee types are contained in the Schedules. Each Schedule corresponds to a particular regulatory domain (CTGT products, clinical research material, cosmetic notifications/certificates, retail pharmacy-related matters, medical devices, oral dental gums, therapeutic products, and active ingredients).
- Cross-regulatory integration: The Regulations rely heavily on definitions and references to other regulations made under the Health Products Act 2007. This means the fee instrument is best read together with the substantive licensing/registration/approval regulations it references.
Who Does This Legislation Apply To?
The Regulations apply to persons or entities who engage in regulated activities that trigger HSA’s fee-charging processes under the various referenced regulations. In practice, this includes manufacturers, importers, suppliers, applicants for registration, and parties submitting notifications or applications for certificates and advertisements in the relevant product categories.
Because Section 3 ties fees to specific regulatory regimes, applicability is determined by what you are trying to do (e.g., register a therapeutic product, submit a cosmetic notification, apply for a GMPC certificate, obtain advertisement approval for oral dental gums, or pay retention fees for certain registered products). The Regulations do not generally apply to activities outside those regimes, and they do not replace substantive eligibility requirements under the Health Products Act and its product-specific regulations.
Why Is This Legislation Important?
For practitioners, the Health Products (Fees) Regulations 2022 is important because it directly affects cost planning, application management, and compliance timelines. Many regulatory projects fail not because the substantive requirements are unmet, but because procedural steps—such as payment timing—are missed or mishandled. Section 4’s “pay when submitted” rule for application and advertisement fees is particularly significant for internal workflows, procurement processes, and legal project management.
The Regulations also have strategic implications for registration lifecycle management. The inclusion of retention fees payable on or before each anniversary of registration date means that ongoing compliance is not only about maintaining regulatory status; it is also about meeting recurring financial obligations. Counsel advising on renewals, corporate restructuring, or product portfolio management should treat retention fees as a recurring compliance calendar item.
Finally, Section 5’s waiver/refund discretion provides a mechanism for relief. While not a right, it can be relevant in disputes or when clients face administrative burdens or errors. In practice, this provision supports a more nuanced approach: rather than treating fees as purely mechanical, counsel can consider whether a waiver/refund request is appropriate and how to frame it in a way that aligns with HSA’s administrative discretion.
Related Legislation
- Health Products Act 2007 (authorising Act; includes section 31(a) referenced in relation to 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.