Statute Details
- Title: Health Products (Fees) Regulations 2022
- Act Code: HPA2007-S450-2022
- Legislative Type: Subsidiary legislation (SL)
- Authorising Act: Health Products Act 2007
- Power to Make: Section 71 of the Health Products Act 2007 (with Minister for Health’s approval)
- Citation and Commencement: Commenced on 1 July 2022
- Status / Version: Current version as at 27 Mar 2026
- Key Provisions (from extract): Sections 1–5; First to Ninth Schedules
- Most Relevant Operational Themes: (i) fees payable to the Health Sciences Authority (HSA), (ii) timing of payment, (iii) waiver/refund discretion, and (iv) fee mapping across multiple regulatory regimes (CTGT, clinical research materials, GMPC-CP, retail pharmacies, medical devices, oral dental gums, therapeutic products, and active ingredients)
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 health product regulatory activities. In practical terms, it is the “pricing and payment mechanics” layer that sits alongside the substantive licensing, registration, and approval regimes under the Health Products Act 2007 and its related subsidiary regulations.
Rather than creating new substantive regulatory requirements (such as what must be licensed or how products must be evaluated), these Regulations focus on administrative cost recovery. They specify which fees apply to which categories of health products and regulatory processes, and they prescribe when those fees must be paid (e.g., at submission, at acceptance for evaluation, or on anniversary dates for retention fees).
The Regulations also provide a discretionary waiver/refund mechanism. This is important for practitioners because fee disputes, hardship, or procedural circumstances may arise during applications, evaluations, advertisements, or ongoing registration/retention. Section 5 gives HSA flexibility to adjust fees in appropriate cases.
What Are the Key Provisions?
1. Citation and commencement (Section 1)
Section 1 provides the formal name and commencement date: the Regulations are cited as the Health Products (Fees) Regulations 2022 and come into operation on 1 July 2022. For legal practitioners, this matters for determining which fee schedule applies to applications submitted before and after commencement, and for assessing whether any later amendments affect pending matters.
2. Definitions and cross-references (Section 2)
Section 2 is a definitional gateway that links the fee framework to multiple specialised regulatory regimes. It defines key terms such as CTGT product, clinical research material, and various categories of health products and regulatory instruments (for example, the CTGTP Regulations, CRM Regulations, GMPC-CP Regulations, MD Regulations, ODG Regulations, TP Regulations, LRP Regulations, and the AI Regulations).
Practically, this cross-referencing is crucial: the fee Regulations do not operate in isolation. They “attach” the correct fee schedule to the correct substantive process under each regime. For example, fees for medical devices are not described in detail in the fee Regulations themselves; instead, Section 3 points to the Sixth Schedule for the relevant medical device activities under the MD Regulations.
3. Fees payable to the Authority (Section 3 and Schedules)
Section 3 is the core mapping provision. It states that the fees specified in each Schedule are payable to HSA for particular activities. In the extract, the structure is clear:
- 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 framework).
- 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 (added by amendment effective 18 December 2023).
For practitioners, the legal significance is that Section 3 provides the statutory authority for HSA to charge the fees listed in each Schedule. When advising clients, counsel should identify (i) the product category, (ii) the relevant regulatory regime, and (iii) the specific activity (application, evaluation, advertisement, registration, retention, etc.) to determine which Schedule and fee type applies.
4. Time for payment of fees (Section 4)
Section 4 prescribes when fees must be paid. This is often where applications succeed or fail administratively, because late payment can lead to processing delays or non-acceptance.
- 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 transfer of approval) specified in the Seventh Schedule, the 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, the 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 Act, 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 create a practical compliance calendar. For example, retention fees require ongoing monitoring of registration anniversaries. Evaluation fees depend on HSA’s acceptance after initial screening, which may affect budgeting and cashflow planning.
5. Waiver or refund (Section 5)
Section 5 provides that HSA may, in any particular case or class of cases, waive or refund the whole or any part of any fee payable or paid under any Schedule. This is a discretionary power, not an entitlement.
From a legal advisory perspective, Section 5 is relevant in at least three scenarios: (i) where an application is withdrawn or becomes moot due to regulatory or commercial reasons, (ii) where procedural circumstances lead to partial work being performed, and (iii) where fairness considerations arise (for example, administrative errors or exceptional circumstances). Counsel should also note that because the power is discretionary, the strongest submissions will typically be those that align with HSA’s administrative practice and demonstrate proportionality.
How Is This Legislation Structured?
The Regulations are structured as follows:
- Part/Section framework: The extract shows an “Enacting Formula” and then a short set of operative sections.
- Sections 1–5:
- Section 1 (Citation and commencement)
- Section 2 (Definitions and cross-references)
- Section 3 (Fees payable to HSA, mapped to product categories and regulatory regimes via Schedules)
- Section 4 (Time for payment: when fees must be paid)
- Section 5 (Waiver or refund discretion)
- Schedules (First to Ninth): Each Schedule contains the actual fee amounts and fee categories for the relevant regulatory activities under the corresponding subsidiary regulations.
Although the extract does not reproduce the fee tables, the legal architecture is clear: the operative sections establish the legal basis for charging fees and the timing for payment, while the Schedules provide the quantum and specific fee types.
Who Does This Legislation Apply To?
The Regulations apply to persons and entities that engage in regulated activities under the Health Products regulatory framework administered by HSA—particularly those involved in manufacturing, importing, supplying, registering, notifying, certifying, advertising, and maintaining registrations for the relevant categories of health products.
In practice, this includes (depending on the Schedule and activity): manufacturers and importers of CTGT products, sponsors or parties dealing with clinical research materials, cosmetic industry participants making notifications under the ASEAN Cosmetic Directive regime, applicants for GMPC certificates for cosmetic products, retail pharmacy operators, medical device registrants, manufacturers and registrants of oral dental gums (including advertisement approvals), therapeutic product registrants, and active ingredient manufacturers/importers/suppliers (under the AI Regulations).
Why Is This Legislation Important?
Although the Health Products (Fees) Regulations 2022 is “only” about fees, it has real operational and legal consequences. In regulated industries, fee payment is not a mere administrative step—it is often a condition for processing. Section 4’s timing requirements mean that a failure to pay at the correct time can delay evaluation, affect acceptance for registration, or complicate subsequent steps.
For practitioners, the Regulations also provide a structured way to advise clients across multiple product categories. Section 3’s Schedule mapping reduces ambiguity: once the product is classified and the applicable regulatory regime is identified, the relevant Schedule and fee type can be determined. This is particularly useful in multi-product portfolios where different regulatory regimes apply simultaneously.
Finally, Section 5’s waiver/refund discretion is an important risk-management tool. Where a client faces financial exposure due to procedural developments, counsel can consider whether a waiver/refund request is appropriate and how to frame it. While not guaranteed, the existence of a statutory discretion supports engagement with HSA on fairness and proportionality.
Related Legislation
- Health Products Act 2007 (authorising Act; including section 71 (making power) and section 31(a) (retention fee context))
- 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.