Health Products (Fees) Regulations 2022

No. S 450

Health Products Act 2007

Health Products
(Fees) Regulations 2022

In exercise of the powers conferred by section 71 of the Health Products Act 2007, the Health Sciences Authority, with the approval of the Minister for Health, makes the following Regulations:

Citation and commencement

1.  These Regulations are the Health Products (Fees) Regulations 2022 and come into operation on 1 July 2022.

Definitions

2.  In these Regulations, unless the context otherwise requires —

“AI Regulations” means the Health Products (Active Ingredients) Regulations 2023 (G.N. No. S 831/2023);

[S 833/2023 wef 18/12/2023]

“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).

Fees payable to Authority

3.—(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.

(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.

(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.

(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.

(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.

(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.

(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.

(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.

(9)  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.

[S 833/2023 wef 18/12/2023]

Time for payment of fees

4.—(1)  An application fee mentioned in any of the Schedules must be paid when the application is submitted to the Authority.

(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.

(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.

(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.

Waiver or refund of fees

5.  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.

Made on 25 May 2022.

BENJAMIN ONG

Chairperson,
Health Sciences Authority,
Singapore.

[401:04/01-000; AG/LEGIS/SL/122D/2020/17 Vol. 1]