Health Products (Cell, Tissue and Gene Therapy Products) (Amendment) Regulations 2022

No. S 451

Health Products Act 2007

Health Products
(Cell, Tissue and Gene Therapy Products)
(Amendment) Regulations 2022

In exercise of the powers conferred by sections 71 and 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 (Cell, Tissue and Gene Therapy Products) (Amendment) Regulations 2022 and come into operation on 1 July 2022.

Amendment of regulation 2

2. In regulation 2(1) of the Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021 (G.N. No. S 104/2021) (called in these Regulations the principal Regulations), after the definition of “qualified practitioner”, insert —

“ “relevant fee” means a fee specified in the First Schedule to the Health Products (Fees) Regulations 2022 (G.N. No. S 450/2022);”.

New regulation 29A

3. After regulation 29 of the principal Regulations, insert —

“Prescribed time for cancellation of registration of CTGT product for non‑payment of retention fee

29A. For the purposes of section 37(2) of the Act, the prescribed time is 60 days after the anniversary of the date of the registration of the CTGT product.”.

Deletion of regulation 59

4. Delete regulation 59 of the principal Regulations.

Deletion of Schedule

5. Delete the Schedule to the principal Regulations.

Miscellaneous amendments

6. In the following provisions of the principal Regulations, delete “specified in the Schedule”:

Regulation 4(2)(c)

Regulation 7(2)(c)

Regulation 10(2)(c)

Regulation 16(2)

Regulation 45(2)(d)

Regulation 48(2)(d)

Regulation 52(2)(b)

Regulation 53(3)(b)

Regulation 54(3)(b)

Regulation 55.

[G.N. No. S 1076/2021]

Made on 25 May 2022.

BENJAMIN ONG

Chairperson,
Health Sciences Authority,
Singapore.

[401:04/01-000; AG/LEGIS/SL/122D/2020/13 Vol. 1]

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

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