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 used in the system of therapeutics according to the traditional Chinese method, that is to say, any medicinal product —

(a)	which has been manufactured into a finished product;
(b)	which contains one or more active substances derived wholly from any plant, animal or mineral, or any combination thereof; and
(c)	which is, or all of the active substances of which are, described in the current edition of “A Dictionary of Chinese Pharmacy” <<中药大辞典>> or “The Chinese Herbal Medicine Materia Medica” <<本草纲目>>,

but does not include —

(i)	any medicinal product to be administered by injection into a human body; or
(ii)	any medicinal product which contains as an active substance any chemically-defined isolated constituent of any plant, animal or mineral, or any combination thereof;

“current edition”, in relation to any publication which describes a Chinese proprietary medicine, 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 that edition of the publication up to that time;

“homoeopathic medicine” means any substance used in the system of therapeutics in which a disease is treated by the use of minute amounts of one or more substances which, in their undiluted forms, are capable of producing in a healthy human being symptoms similar to those of the disease being treated;

“medicated oil and balm” means any external medicated embrocation, medicated cream, ointment or inhalant —

(a)

which is used mainly for soothing purposes; and

(b)

which contains one or more of the following substances as an active ingredient or as active ingredients:

(i)	any essential oil;
(ii)	any fixed oil derived from a plant;
(iii)	methyl salicylate;
(iv)	menthol;
(v)	camphor;
(vi)	peppermint;

“quasi-medicinal product” means —

(a)	any anti-dandruff preparation;
(b)	any medicated cosmetic product for the treatment of pimples or acne, except any preparation containing etretinate or 13-cis-retinoic acid;
(c)	any medicated soap;
(d)	any sweet for relieving coughs or throat irritations;
(e)	any medicated plaster;
(f)	any sunscreen or suntan preparation;
(g)	any medicated beverage;
(h)	any vitamin or nutritional preparation from any plant, animal or mineral, or any combination thereof; or
(i)	any medicated toothpaste;

“traditional medicine” means any medicinal product consisting of one or more substances derived from any plant, animal or mineral, or any combination thereof, but does not include the following:

(a)	any medicinal product to be administered by injection into a human body;
(b)	any vaccine to be administered to a human being;
(c)	any product derived from human blood;
(d)	any item specified in the Poisons List in the Schedule to the Poisons Act (Cap. 234);
(e)	any Chinese proprietary medicine. [S 712/2012 wef 01/01/2013]

Exemption from certain provisions of sections 5 and 6 of Act for Chinese proprietary medicines

2A.—(1) Section 5(1) of the Act shall not have effect in relation to any person who —

(a)	sells, supplies or exports;
(b)	procures the sale, supply or export of; or
(c)	procures for sale, supply or export, the manufacture or assembly of,

any Chinese proprietary medicine.

(2) Section 6(4) of the Act shall not have effect in relation to any person who manufactures or assembles any Chinese proprietary medicine for sale or supply to any other person, or for export.

[S 712/2012 wef 01/01/2013]

Exemption from sections 5 and 6 of Act for other substances

3.—(1) 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.

[S 658/2019 wef 01/01/2020]

(2) Sections 5 and 6 of the Act do not apply to a person in respect of that person selling, offering for sale, supplying, exporting, importing, manufacturing, assembling, or selling or offering for sale by way of wholesale dealing any topical antiseptic that does not contain mercury or any compound of mercury.

[S 658/2019 wef 01/01/2020]

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.

Import of medicinal products solely for re-export

5.—(1) Subject to sub-paragraph (2), the licensing authority may permit a person, subject to such terms and conditions as the licensing authority thinks fit, to import a medicinal product solely for re‑export without holding a product licence or an import licence.

(2) Sub-paragraph (1) does not apply to the import of a topical antiseptic that contains mercury or any compound of mercury.

[S 658/2019 wef 01/01/2020]

Export of medicinal products manufactured solely for export

6.—(1) Subject to sub-paragraph (2), the licensing authority may permit a person, subject to such terms and conditions as the licensing authority thinks fit, to export a medicinal product manufactured solely for export without holding a product licence.

(2) Sub-paragraph (1) does not apply to the export of a topical antiseptic that contains mercury or any compound of mercury.

[S 658/2019 wef 01/01/2020]

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