Health Products (Therapeutic Products) (Amendment No. 3) Regulations 2023

No. S 811

Health Products Act 2007

Health Products
(Therapeutic Products)
(Amendment No. 3) Regulations 2023

In exercise of the powers conferred by section 72 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 (Therapeutic Products) (Amendment No. 3) Regulations 2023 and come into operation on 18 December 2023.

Amendment of regulation 2

2. In the Health Products (Therapeutic Products) Regulations 2016 (G.N. No. S 329/2016) (called in these Regulations the principal Regulations), in regulation 2(1) —

(a)

replace the definition of “acute hospital service”, “ambulatory surgical centre service”, “assisted reproduction service”, “blood banking service”, “community hospital service”, “contingency care service”, “nuclear medicine service”, “outpatient dental service”, “outpatient medical service”, “outpatient renal dialysis service” and “radiological service” with —

“ “acute hospital service”, “ambulatory surgical centre service”, “assisted reproduction service”, “blood banking service”, “community hospital service”, “contingency care service”, “nuclear medicine service”, “nursing home service”, “outpatient dental service”, “outpatient medical service”, “outpatient renal dialysis service” and “radiological service” have the meanings given by paragraph 2 of the First Schedule to the Healthcare Services Act 2020;”;

(b)

delete the definitions of “nursing home” and “nursing home licensee”;

(c)

replace the definition of “personnel” with —

“ “personnel”, in relation to a healthcare service licensee providing a licensable healthcare service, means any individual employed or engaged by the healthcare service licensee to assist the licensee in providing a licensable healthcare service;”; and

(d)

in the definition of “specified healthcare service licensee”, after paragraph (g), insert —

“(ga)

a nursing home service;”.

Amendment of regulation 5

3. In the principal Regulations, in regulation 5(1)(b), replace sub‑paragraph (i) with —

“(i)	is imported on behalf of a specified healthcare service licensee pursuant to a valid prescription given by a qualified practitioner (who is a personnel of the specified healthcare service licensee) for the use of the qualified practitioner’s patient;”.

Amendment of regulation 11

4. In the principal Regulations, in regulation 11, replace paragraph (b) with —

“(b)	the supply is made by a healthcare service licensee to a patient of the healthcare service licensee, and is in accordance with the written instructions of a qualified practitioner or collaborative prescribing practitioner who is a personnel of the healthcare service licensee;”.

Amendment of regulation 13

5. In the principal Regulations, in regulation 13(1), replace sub‑paragraph (b) with —

“(b)	the supply is made by a healthcare service licensee to a patient of the healthcare service licensee, and is in accordance with the written instructions of a qualified practitioner or collaborative prescribing practitioner who is a personnel of the healthcare service licensee; or”.

Amendment of regulation 17

6. In the principal Regulations, in regulation 17(1)(b)(i), delete “nursing home or” wherever it appears.

Amendment of regulation 31

7. In the principal Regulations, in regulation 31(1), delete “a nursing home licensee or”.

Amendment of regulation 32

8. In the principal Regulations, in regulation 32(1)(b), replace “58(1)(a), (b),” with “58(1)(b),”.

Replacement of Division heading in Part 7

9. In the principal Regulations, in Part 7, in Division 1, replace the Division heading with —

“Division 1 — Specified healthcare service licensees”.

Amendment of regulation 46

10. In the principal Regulations, in regulation 46 —

(a)	in the regulation heading, delete “nursing homes, or”;
(b)	in paragraph (1), delete “nursing home licensee or a”;
(c)	in paragraph (1)(c), delete sub‑paragraph (i);
(d)	in paragraph (4), delete sub‑paragraph (a);
(e)	in paragraph (5), delete sub‑paragraph (a); and
(f)	in paragraphs (7) and (9), delete “a nursing home licensee or”.

Amendment of regulation 47

11. In the principal Regulations, in regulation 47 —

(a)	in the regulation heading, delete “nursing homes licensees and”;
(b)	delete paragraph (1);
(c)	in paragraph (2), delete sub‑paragraph (a);
(d)	in paragraph (3), delete sub‑paragraph (a);
(e)	in paragraph (4), delete “nursing home licensee or a”; and
(f)	in paragraph (4), delete “nursing home licensee or”.

Amendment of regulation 48

12. In the principal Regulations, in regulation 48(2)(b), delete “a nursing home licensee or”.

Amendment of regulation 49

13. In the principal Regulations, in regulation 49(a), delete “a nursing home licensee or”.

Amendment of regulation 51

14. In the principal Regulations, in regulation 51(1) —

(a)	delete “a nursing home licensee or”; and
(b)	in sub-paragraph (a), delete “nursing home licensee or”.

Amendment of regulation 58

15. In the principal Regulations, in regulation 58(1) —

(a)	delete sub-paragraph (a);
(b)	in sub-paragraph (b), delete sub‑paragraph (i);
(c)	in sub-paragraph (c), delete “a nursing home licensee or”;
(d)	in sub-paragraph (c), replace “any nursing home licensee or specified healthcare service licensee, as the case may be” with “any specified healthcare service licensee”;
(e)	in sub-paragraph (ca), delete sub‑paragraph (i);
(f)	in sub-paragraphs (f) and (g), delete “a nursing home licensee or”; and
(g)	in sub-paragraph (g), replace “the nursing home licensee or specified healthcare service licensee” with “the specified healthcare service licensee”.

Amendment of regulation 59

16. In the principal Regulations, in regulation 59 —

(a)	in paragraph (1)(a), delete sub-paragraph (i);
(b)	in paragraph (1), delete sub-paragraph (b);
(c)	in paragraph (2)(a), delete “the nursing home licensee mentioned in paragraph (1)(a)(i) or (b), or”;
(d)	in paragraph (2)(b), delete sub-paragraph (i); and
(e)	in paragraph (3), delete “a nursing home licensee mentioned in paragraph (1)(a)(i) or (b) or”.

[G.N. Nos. S 219/2017; S 119/2018; S 92/2019; S 969/2020; S 732/2021; S 1081/2021; S 458/2022; S 436/2023; S 681/2023]

Made on 24 November 2023.

BENJAMIN ONG

Chairperson,
Health Sciences Authority,
Singapore.

[78:44/1; 401:04/01-000; AG/LEGIS/SL/122D/2020/4 Vol. 2]

(To be presented to Parliament under section 72(5) of the Health Products Act 2007).

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