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Singapore legislation

Regulation 9

of Medicines (Labelling of Chinese Proprietary Medicines) Regulations

Regulation 9

Additional information to be shown on container, etc., of Chinese proprietary medicine

Amended byS 315/2005 wef 27/05/2005

Subregulation 1

Amended byS 315/2005 wef 27/05/2005

No person shall sell or supply any Chinese proprietary medicine unless it is labelled in accordance with this regulation —

(a)

with the following statement in English:“Allowed for sale as a Chinese Proprietary Medicine based on information submitted to the Authority. Consumer discretion is advised.”; and

(b)

with the following statement in Chinese:“根据向当局提呈的资料允许作为中成药销售,谨慎选用.”.

Subregulation 2

The statements specified in paragraph (1) shall be appended in the following manner:

(a)

where the Chinese proprietary medicine is or is intended to be sold or supplied by way of retail in a container without being enclosed in any other package, on that container;

(b)

where the Chinese proprietary medicine is or is intended to be sold or supplied by way of retail in a container which is immediately enclosed in a package, on that package; or

(c)

where the Chinese proprietary medicine is or is intended to be sold or supplied by way of retail packaged together with any other Chinese proprietary medicine (whether or not of the same type) so as to form a single unit, on the outermost package of that unit.

Subregulation 3

Subject to paragraph (4), the statements specified in paragraph (1) —

(a)

shall be printed —

(i)

in the case of the statement in English, in a font size not less than 1.5 millimetres in height; and

(ii)

in the case of the statement in Chinese, in a font size not less than 2 millimetres in height;

(b)

shall be clearly legible; (c)shall be printed in an indelible manner;

(d)

shall appear conspicuously in a prominent position on the relevant container or package so as to be easily read by an intending purchaser or user of the Chinese proprietary medicine under normal conditions of purchase or use;

(e)

may appear together or separately; and

(f)

shall, wherever appearing, be in a boxed area which does not contain any other information or particulars.

Subregulation 4

Notwithstanding paragraph (3)(a), the statements specified in paragraph (1) may be printed in a reduced font size where the relevant container or package is so small as to prevent the use of the relevant font size specified in paragraph (3)(a).

Subregulation 5

For the purposes of paragraph (2) —

(a)

where a container is in the form of a bubble, blister or other sealed unit and is part of a continuous series comprising a sheet or strip of like containers, each sheet or strip of such containers by which the Chinese proprietary medicine is sold or supplied shall be treated as the container specified in paragraph (2)(a); and

(b)

where the package immediately enclosing a container referred to in sub-paragraph (a) is itself in the form of a bubble, blister or other sealed unit and is part of a continuous series comprising a sheet or strip of like packages, each sheet or strip of such packages by which the Chinese proprietary medicine is sold or supplied shall be treated as the package specified in paragraph (2)(b).