Regulation 1
Citation and commencement
These Regulations are the Health Products (Fees) Regulations 2022 and come into operation on 1 July 2022.
/akn/sg/act/sub_leg/2007/HPA-S450-2022
Health Products (Fees) Regulations 2022
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- Type
- Subsidiary Legislation
- Status
- In force
- Enacted
- 2007
- Sections
- 5
Quick answer
About this subsidiary legislation
Health Products (Fees) Regulations 2022 is Singapore Subsidiary Legislation, cited as Subsidiary Legislation HPA-S450-2022 2007, currently marked in force and first recorded in 2007.
Regulation 2
Definitions
Amended byS 833/2023 wef 18/12/2023
In these Regulations, unless the context otherwise requires —“AI Regulations” means the Health Products (Active Ingredients) Regulations 2023 (G.N. No. S 831/2023);“clinical research material” has the meaning given by regulation 2(1) of the CRM Regulations;“CP-ACD Regulations” means the Health Products (Cosmetic Products — ASEAN Cosmetic Directive) Regulations 2007 (G.N. No. S 683/2007);“CRM Regulations” means the Health Products (Clinical Research Materials) Regulations 2016 (G.N. No. S 332/2016);“CTGT product” means a health product categorised as a cell, tissue or gene therapy product in the First Schedule to the Act;“CTGTP Regulations” means the Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021 (G.N. No. S 104/2021);“GMPC-CP Regulations” means the Health Products (Good Manufacturing Practice Certificate — Cosmetic Products) Regulations 2011 (G.N. No. S 543/2011);“LRP Regulations” means the Health Products (Licensing of Retail Pharmacies) Regulations 2016 (G.N. No. S 330/2016);“MD Regulations” means the Health Products (Medical Devices) Regulations 2010 (G.N. No. S 436/2010);“medical device” means a health product categorised as a medical device in the First Schedule to the Act;“ODG Regulations” means the Health Products (Oral Dental Gums) Regulations 2016 (G.N. No. S 539/2016);“oral dental gum” means a health product categorised as an oral dental gum in the First Schedule to the Act;“retail pharmacy” has the meaning given by regulation 2 of the LRP Regulations;“therapeutic product” means a health product categorised as a therapeutic product in the First Schedule to the Act;“TP Regulations” means the Health Products (Therapeutic Products) Regulations 2016 (G.N. No. S 329/2016).
Definition
“AI Regulations” means the Health Products (Active Ingredients) Regulations 2023 (G.N. No. S 831/2023);
Amended byS 833/2023 wef 18/12/2023
Definition
“clinical research material” has the meaning given by regulation 2(1) of the CRM Regulations;
Definition
“CP-ACD Regulations” means the Health Products (Cosmetic Products — ASEAN Cosmetic Directive) Regulations 2007 (G.N. No. S 683/2007);
Definition
“CRM Regulations” means the Health Products (Clinical Research Materials) Regulations 2016 (G.N. No. S 332/2016);
Definition
“CTGT product” means a health product categorised as a cell, tissue or gene therapy product in the First Schedule to the Act;
Definition
“CTGTP Regulations” means the Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021 (G.N. No. S 104/2021);
Definition
“GMPC-CP Regulations” means the Health Products (Good Manufacturing Practice Certificate — Cosmetic Products) Regulations 2011 (G.N. No. S 543/2011);
Definition
“LRP Regulations” means the Health Products (Licensing of Retail Pharmacies) Regulations 2016 (G.N. No. S 330/2016);
Definition
“MD Regulations” means the Health Products (Medical Devices) Regulations 2010 (G.N. No. S 436/2010);
Definition
“medical device” means a health product categorised as a medical device in the First Schedule to the Act;
Definition
“ODG Regulations” means the Health Products (Oral Dental Gums) Regulations 2016 (G.N. No. S 539/2016);
Definition
“oral dental gum” means a health product categorised as an oral dental gum in the First Schedule to the Act;
Definition
“retail pharmacy” has the meaning given by regulation 2 of the LRP Regulations;
Definition
“therapeutic product” means a health product categorised as a therapeutic product in the First Schedule to the Act;
Definition
“TP Regulations” means the Health Products (Therapeutic Products) Regulations 2016 (G.N. No. S 329/2016).
Regulation 3
Fees payable to Authority
Amended byS 833/2023 wef 18/12/2023
Subregulation 1
The fees specified in the First Schedule are payable to the Authority for the manufacture, import, supply and registration of CTGT products under the CTGTP Regulations.
Subregulation 2
The fees specified in the Second Schedule are payable to the Authority for the manufacture, import and supply of clinical research material under the CRM Regulations.
Subregulation 3
The fees specified in the Third Schedule are payable to the Authority for the submission of a notification under regulation 4 of the CP‑ACD Regulations.
Subregulation 4
The fees specified in the Fourth Schedule are payable to the Authority for an application for a certificate under regulation 3 of the GMPC‑CP Regulations.
Subregulation 5
The fees specified in the Fifth Schedule are payable to the Authority in relation to retail pharmacies and the supply of certain health products under the LRP Regulations.
Subregulation 6
The fees specified in the Sixth Schedule are payable to the Authority for the manufacture, import, supply and registration of medical devices under the MD Regulations.
Subregulation 7
The fees specified in the Seventh Schedule are payable to the Authority for the manufacture, import, supply, registration and advertisement of oral dental gums under the ODG Regulations.
Subregulation 8
The fees specified in the Eighth Schedule are payable to the Authority for the manufacture, import, supply and registration of therapeutic products under the TP Regulations.
Subregulation 9
Amended byS 833/2023 wef 18/12/2023
The fees specified in the Ninth Schedule are payable to the Authority for the manufacture, import and supply of active ingredients under the AI Regulations.
Regulation 4
Time for payment of fees
Subregulation 1
An application fee mentioned in any of the Schedules must be paid when the application is submitted to the Authority.
Subregulation 2
An approval fee in respect of any advertisement, including any variation of an approved advertisement or transfer of approval of an advertisement, specified in the Seventh Schedule must be paid when the application for the advertisement is submitted to the Authority.
Subregulation 3
An evaluation fee for the registration of a health product specified in the First, Sixth or Eighth Schedule is payable upon the Authority’s acceptance of the respective health product for evaluation after the Authority has conducted an initial screening.
Subregulation 4
For the 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 date of registration of the respective health product.
Regulation 5
Waiver or refund of fees
The Authority 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 of the Schedules.
Common questions
- What is Health Products (Fees) Regulations 2022?
- Health Products (Fees) Regulations 2022 is Singapore Subsidiary Legislation, cited as Subsidiary Legislation HPA-S450-2022 2007, currently marked in force and first recorded in 2007.
- Is Health Products (Fees) Regulations 2022 still in force?
- Yes — Health Products (Fees) Regulations 2022 is currently in force.
- When did Health Products (Fees) Regulations 2022 take effect?
- Health Products (Fees) Regulations 2022 was first recorded in 2007.
- How many regulations does Health Products (Fees) Regulations 2022 have?
- Health Products (Fees) Regulations 2022 contains 5 regulations.
- Where can I read the official version of Health Products (Fees) Regulations 2022?
- The official text of Health Products (Fees) Regulations 2022 is published at sso.agc.gov.sg.