Singapore legislation

Regulation 24

of Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021

Regulation 24

Trade descriptions

Subregulation 1

For the purposes of section 18(1) of the Act, the presentation of a CTGT product must comply with all the following requirements:

(a)

a trade description which is false or misleading must not be applied to the CTGT product;

(b)

a trade description which explicitly or implicitly suggests that the supply or use of the CTGT product is promoted or endorsed by the Authority, the Ministry of Health or the Health Promotion Board must not be applied to the CTGT product.

Subregulation 2

For the purposes of paragraph (1)(a), a trade description is false or misleading if —

(a)

it contains any false statement or information concerning the CTGT product; or

(b)

it is likely to create an erroneous impression regarding the formulation, specifications, quality, safety, efficacy or uses of the CTGT product.

Subregulation 3

For the purposes of paragraph (1), a person applies a trade description to a CTGT product if the person —

(a)

affixes or annexes the trade description to, or in any manner marks it on or incorporates it in —

(i)

the CTGT product; or

(ii)

any thing in or on the CTGT product or with which the CTGT product is supplied;

(b)

places the CTGT product in, on or with any thing which the trade description has been affixed or annexed to, marked on or incorporated in; or

(c)

makes any oral or written statement of the trade description, or uses the trade description in any other manner, which is likely to be understood as referring to the CTGT product.

Subregulation 4

A person supplying a CTGT product is taken to have applied a trade description to the CTGT product if —

(a)

the CTGT product is supplied pursuant to a request in which the trade description is used; and

(b)

it is reasonable in the circumstances to infer that any CTGT product so supplied will correspond to that trade description.