Medicines (Traditional Medicines, Homoeopathic Medicines and other Substances) (Exemption) Order

Medicines Act

(CHAPTER 176, Section 9)

O 6

G.N. No. S 173/1987

REVISED EDITION 2005

(31st March 2005)

[30th June 1987]

Citation

1. This Order may be cited as the Medicines (Traditional Medicines, Homoeopathic Medicines and other Substances) (Exemption) Order.

Definitions

2. In this Order, unless the context otherwise requires —

“Chinese proprietary medicine” means any medicinal product —

(a)	in tablet or capsule form for oral consumption from 1st September 1999;
(b)	in tablet or capsule form for oral consumption, or in liquid form for oral consumption or external application, from 1st September 2000; and
(c)	in any dosage form from 1st September 2001,

used in the system of therapeutics according to the traditional Chinese method, that is to say, any medicinal product which has been manufactured into a finished product and contains one or more active substances, all of which are derived wholly from plants, animals or minerals or a combination of any one or more of them, and the medicinal product or all of its active substances are described in the current edition of “A Dictionary of Chinese Pharmacy” «中药大辞典», “The Chinese Herbal Medicine Materia Medica” «本草纲目» or such other publication as may be approved by the Minister, but shall not include —

(i)	any medicinal product to be injected into the human body;
(ii)	any item specified in the Poisons List in the Schedule to the Poisons Act (Cap. 234); or
(iii)	any medicinal product which contains as an active substance any chemically defined isolated constituent of plants, animals or minerals or a combination of any one or more of them;

“current edition”, in relation to any publication, means an edition which is current at the time the Chinese proprietary medicine in question is sold or supplied, and includes any amendment, addition or deletion made to it up to that time;

“homoeopathic medicine” means any substance used in the system of therapeutics in which diseases are treated by the use of minute amounts of such substance which are capable of producing in healthy persons symptoms similar to those of the disease being treated;

“medicated oil and balm” means any external medicated embrocation, medicated cream, ointment or inhalant used mainly for soothing purposes, and contains essentially the following active ingredients:

(a)	essential oils;
(b)	fixed oils derived from plants;
(c)	methyl salicylate;
(d)	menthol;
(e)	camphor; and
(f)	peppermint;

“quasi-medicinal product” means any of the following products:

(a)	anti-dandruff preparations;
(b)	medicated cosmetics for the treatment of pimples and acne, except preparations containing etretinate or 13-cis-retinoic acid;
(c)	medicated soap;
(d)	sweets for relieving cough and throat irritations;
(e)	medicated plasters;
(f)	sunscreen and suntan preparations;
(g)	medicated beverages;
(h)	vitamins and nutritional preparations from natural sources; or
(i)	medicated toothpaste;

“traditional medicine” means any medicinal product consisting of one or more substances derived from natural sources, that is to say, plants, animals or minerals or a combination of any one or more of them, but shall not include —

(a)	any medicinal product to be injected into the human body;
(b)	any vaccine to be used by human beings;
(c)	any product derived from human blood;
(d)	any item specified in the Poisons List in the Schedule to the Poisons Act (Cap. 234); and
(e)	any Chinese proprietary medicine.

Exemption from sections 5 and 6 of Act

3. Sections 5 and 6 of the Act shall not have effect in relation to any person in respect of his selling, offering for sale, supplying, importing, manufacturing, assembling, or in respect of his selling or offering for sale by way of wholesale dealing any of the following products:

(a)	traditional medicines;
(b)	homoeopathic medicines;
(c)	quasi-medicinal products;
(d)	raw materials which are used as ingredients in the preparation or manufacture of any medicinal product; or
(e)	medicated oil and balm.

Importation of medicinal product without licence

4. The licensing authority may permit the importation of any medicinal product —

(a)	by any person for the purpose of administering the medicinal product to himself or to any member of his family;
(b)	by any doctor or dentist for the purpose of administering the medicinal product to any patient of such doctor or dentist; or
(c)	by any pharmacist pursuant to any prescription given by a doctor or dentist,

without a product licence or import licence, as the case may be, if the quantity of the medicinal product imported by any of the persons mentioned in sub-paragraph (a), (b) or (c) does not exceed 3 months supply based on the dosage recommended by the manufacturer or supplier of the product.

Importation solely for re-exportation

5. The licensing authority may permit the importation of medicinal products solely for re-exportation out of Singapore without a product licence or import licence, as the case may be, subject to such terms and conditions as may be imposed by the licensing authority.

Exportation of medicinal products manufactured solely for exportation

6. The licensing authority may permit the exportation without a product licence of medicinal products manufactured solely for exportation out of Singapore, subject to such terms and conditions as may be imposed by the licensing authority.

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