Singapore legislation

Regulation 19

of Health Products (Therapeutic Products) Regulations 2016

Regulation 19

Trade descriptions

Subregulation 1

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

(a)

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

(b)

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

(b)

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

Subregulation 3

For the purposes of paragraph (1), a person applies a trade description to a therapeutic 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 therapeutic product; or

(ii)

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

(b)

places the therapeutic 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 therapeutic product.

Subregulation 4

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

(a)

the therapeutic 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 therapeutic product so supplied will correspond to that trade description.