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No. S 109

Health Products Act

(CHAPTER 122D)

Health Products
(Advertisement of Therapeutic Products)
(Amendment) Regulations 2021

In exercise of the powers conferred by section 72(1) of the Health Products Act, 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 (Advertisement of Therapeutic Products) (Amendment) Regulations 2021 and come into operation on 1 March 2021.

Amendment of regulation 1

2. Regulation 1 of the Health Products (Advertisement of Therapeutic Products) Regulations 2016 (G.N. No. S 333/2016) (called in these Regulations the principal Regulations) is amended by deleting the words “Therapeutic Products” and substituting the words “Specified Health Products”.

Amendment of regulation 2

3. Regulation 2 of the principal Regulations is amended —

(a)

by inserting, immediately before the definition of “enrolled nurse”, the following definition:

“ “CTGT product” means a health product categorised as a cell, tissue or gene therapy product in the First Schedule to the Act;”; and

(b)

by inserting, immediately after the definition of “sales promotion”, the following definition:

“ “specified health product” means a health product specified in the Second Schedule;”.

Amendment of regulation 3

4. Regulation 3 of the principal Regulations is amended —

(a)

by deleting the words “therapeutic product” and substituting the words “specified health product”; and

(b)

by deleting paragraph (b) and substituting the following paragraph:

“(b)

be undertaken in accordance with the following regulations:

(i)	in the case of any specified health product — regulations 7, 9 and 10;
(ii)	in the case of a therapeutic product only — regulation 8.”.

Amendment of regulation 6

5. Regulation 6(2) of the principal Regulations is amended by deleting the words “Second Schedule” and substituting the words “Third Schedule”.

Amendment of regulation 13

6. Regulation 13(1) of the principal Regulations is amended by inserting, immediately after the words “the registrant” in sub‑paragraph (a), the words “, manufacturer, importer, supplier”.

New Second Schedule

7. The principal Regulations are amended by inserting, immediately after the First Schedule, the following Schedule:

“SECOND SCHEDULE

Regulation 2

SPECIFIED HEALTH PRODUCTS

1. Therapeutic products

2. CTGT products”.

Renaming of Second Schedule

8. The principal Regulations are amended by renaming the existing Second Schedule as the Third Schedule.

Miscellaneous amendments

9. The principal Regulations are amended —

(a)

by deleting the words “therapeutic product” wherever they appear in the following provisions and substituting in each case the words “specified health product”:

Regulation 2 (definitions of “licensee”, “prescription‑only medicine”, “publish” and “sales promotion”)

Regulation 4

Regulation 5

Regulation 6(1)

Regulation 7

Regulation 9(1), (2) and (3)(b)

Regulation 10(1), (2) and (3)

Regulation 11

Regulation 12(2) (definitions of “reference advertisement” and “trade advertisement”)

Regulation 13(1)

Regulation 14(1) and (2)

Regulation 15(1);

(b)

by deleting the words “therapeutic products” in the following regulation headings and substituting in each case the words “specified health products”:

Regulation 3

Regulation 4

Regulation 6

Regulation 9

Regulation 14; and

(c)

by deleting the words “, 7 and 8” in the following provisions and substituting in each case the words “and 7, and in the case of a therapeutic product only, regulation 8,”:

Regulation 11

Regulation 12(1)

Regulation 13(1).

Made on 15 February 2021.

KANDIAH SATKUNANANTHAM

Chairman,
Health Sciences Authority,
Singapore.

[401:04/01-000; AG/LEGIS/SL/122D/2015/7 Vol. 1]

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