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Medicines Act

(CHAPTER 176, Section 30)

Medicines (Prohibition of Sale and Supply) Order

O 4

G.N. No. S 256/1986

REVISED EDITION 2000

(31st January 2000)

[31st March 1987]

Citation

1. This Order may be cited as the Medicines (Prohibition of Sale and Supply) Order.

Definitions

2. In this Order —

“Chinese proprietary medicine” has the same meaning as in the Medicines (Traditional Medicines, Homoeopathic Medicines and other Substances) (Exemption) Order (O 6);

“expiry date” means the date after which, or the month and year after the end of which, a medicinal product should not be used, or the date before which, or the month and year before the beginning of which, a medicinal product should be used.

Restriction on sale and supply of medicinal products

3.—(1) No person shall sell or supply to any person any medicinal product —

(a)	after the expiry date stated in the label on the container or package immediately enclosing the container of the medicinal product;
(b)	which is harmful or unsafe or not in conformity as regards strength, quality or purity with the specification of the medicinal product registered with the licensing authority or, in the case of a medicinal product not registered with the licensing authority, with the specification of the manufacturer; or
(c)	which contains any of the substances in excess of the respective quantities specified in the Schedule.

(2) Sub-paragraph (1)(c) shall not apply to any medicinal product in respect of which a product licence has been granted and remains in force.

Restriction on importation, sale and supply of Chinese proprietary medicine

4.—(1) No person shall import, or sell or supply to any person, any Chinese proprietary medicine for oral consumption which contains —

(a)	total aerobic microbial count of more than 10⁵ per gram or millilitre;
(b)	total yeast and mould count of more than 5 x 10² per gram or millilitre;
(c)	any Escherichia coli in 1 gram or 1 millilitre;
(d)	any Salmonella in 1 gram or 1 millilitre; or
(e)	any Staphylococcus aureus in 1 gram or 1 millilitre,

of the Chinese proprietary medicine.

(2) No person shall import, or sell or supply to any person, any Chinese proprietary medicine for external application which contains —

(a)	total aerobic microbial count of more than 10⁴ per gram or millilitre;
(b)	total yeast and mould count of more than 5 x 10² per gram or millilitre;
(c)	any Pseudomonas aeruginosa in 1 gram or 1 millilitre; or
(d)	any Staphylococcus aureus in 1 gram or 1 millilitre,

of the Chinese proprietary medicine.

(3) Sub-paragraphs (1)(a) and (b) and (2)(a) and (b) shall not apply to any Chinese proprietary medicine which contains any active substance which is derived from plants, animals or a combination thereof and which has been produced by fermentation processes.