Health Products (Exemptions) (Amendment) Order 2023

Status:

Published in Subsidiary Legislation Supplement
on 23 Jun 2023

No. S 435

Health Products Act 2007

Health Products
(Exemptions) (Amendment)
Order 2023

In exercise of the powers conferred by section 70 of the Health Products Act 2007, the Health Sciences Authority makes the following Order:

Citation and commencement

1.—(1) This Order is the Health Products (Exemptions) (Amendment) Order 2023 and, except for paragraph 3, comes into operation on 26 June 2023.

(2) Paragraph 3 is deemed to have come into operation on 31 December 2021.

Amendment of Third Schedule

2. In the Health Products (Exemptions) Order 2016 (G.N. No. S 536/2016), in the Third Schedule, in paragraph 4 —

(a)

in sub‑paragraph (1), before the definition of “out‑of‑specifications CTGT product” or “OOS CTGT product”, insert —

“ “acute hospital service” has the meaning given by paragraph 2 of the First Schedule to the Healthcare Services Act 2020;

“acute hospital service licensee” means a healthcare service licensee who is authorised to provide an acute hospital service;

“approved conveyance”, “approved permanent premises” and “permanent premises” have the meanings given by section 2(1) of the Healthcare Services Act 2020;

“healthcare service licensee” means a person who holds a licence under the Healthcare Services Act 2020 to provide a licensable healthcare service;

“licensable healthcare service” has the meaning given by section 3(1) of the Healthcare Services Act 2020;

“nursing home” means a nursing home within the meaning of the Private Hospitals and Medical Clinics Act 1980 that is licensed under that Act;”;

(b)

in sub‑paragraph (1), in the definition of “requesting qualified practitioner”, replace the full‑stop at the end with a semi‑colon;

(c)

in sub‑paragraph (1), after the definition of “requesting qualified practitioner”, insert —

“ “temporary premises” means any premises other than permanent premises.”; and

(d)

in sub‑paragraph (6)(c), replace sub‑paragraph (iii) with —

“(iii)

where —

(A)

the requesting qualified practitioner is carrying out the treatment at a nursing home — obtains a consensus from a Clinical Ethics Committee appointed by an acute hospital service licensee, and a written endorsement from a relevant specialist who is not involved in the care or treatment of the patient, supporting the administration or application of that OOS CTGT product to that patient; or

(B)

the requesting qualified practitioner is carrying out the treatment at any approved permanent premises, approved conveyance or temporary premises of a healthcare service licensee — obtains a consensus from a Clinical Ethics Committee appointed by the healthcare service licensee or by another healthcare service licensee who is an acute hospital service licensee, and a written endorsement from a relevant specialist who is not involved in the care or treatment of the patient, supporting the administration or application of that OOS CTGT product to that patient;”.

Miscellaneous amendment

3. In the Health Products (Exemptions) Order 2016, in the Second Schedule, in paragraph 2(1)(a), replace “(Cap. 262)” with “2007”.

[G.N. Nos. S 321/2018; S 110/2021]

Made on 21 June 2023.

BENJAMIN ONG

Chairperson,
Health Sciences Authority,
Singapore.

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

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