Guidelines for Traditional Medicinal Materials
These guidelines provide information for the trade in the dealing of traditional medicinal materials in Singapore. The information provided in these guidelines serves to supplement understanding and application of the Laws and Regulations and is not at any time meant to supersede or replace any of the legislation.
The term "traditional medicinal materials" shall cover medicinal materials from plants, animals or minerals in their natural states, or in processed forms that have undergone simple processing, such as cutting or drying (see examples).
Traditional medicinal materials includes materials used in traditional Chinese medicine, traditional Indian medicine, traditional Malay medicine (Jamu) and also herbal medicines from other countries. Herbal materials that are used for food purposes or presented as a food product (e.g. pre-packed raw herbs and flavoured Asian drinks with herbs) do not come under the purview of the Health Sciences Authority.
Traditional medicinal materials basically fall under two broad categories, mainly those sold in loose or bulk form, and those that are pre-packed for sales (stating information such as product name, brand name, ingredients, dosages and/or instructions for use on the packaging materials).
Presently, traditional medicinal materials that are not of finished dosage forms (e.g. capsules, tablets, granules) are not subject to pre-market approval and licensing for their import and sale in Singapore.
However, it is the responsibility of the dealer to ensure that:
(a) The traditional medicinal materials do not contain any substances controlled under the Poisons Act and other prohibited substances such as Pangamic acid including its salts, Danthron, Suprofen including its salts and Rhodamine B.
(b) The heavy metal contents of the traditional medicinal materials do not exceed the following limits: Arsenic (5 ppm), Copper (150 ppm), Lead (20 ppm) and Mercury (0.5 ppm).
From 1 September 2019, the following revised limits of heavy metal contents will be: Arsenic (5 ppm), Cadmium (0.3 ppm), Lead (10 ppm) and Mercury (0.5 ppm). For existing batches imported before 1 September 2019, dealers will have one year grace period to ensure compliance to the revised limits. With effect from 1 September 2020, all traditional medicinal materials selling in Singapore should not exceed the revised limits.
(c) The labels and packaging materials of the traditional medicinal materials (if any) do not stipulate any of the 19 diseases/conditions specified in the Schedule of the Medicines (Advertisement and Sale) Act, namely, blindness, cancer, cataract, drug addiction, deafness, diabetes, epilepsy or fits, hypertension, insanity, kidney diseases, leprosy, menstrual disorders, paralysis, tuberculosis, sexual function, infertility, impotency, frigidity, conception and pregnancy.
For requirements on the advertisement and sales promotion of traditional medicinal materials, please refer to the Guidance on Advertisements of Traditional Medicinal Materials.
If the traditional medicinal materials are controlled under the Endangered Species (Import & Export) Act, dealers should contact the Wildlife Management Group of the NParks at 50 Dairy Farm Road, Singapore 679059, Tel: 1-800-471-7300 (for plants); 1-800-476-1600 (for animals) to obtain the Convention on the International Trade in Endangered Species of Wild Fauna and Flora (CITES) import permits, before they are marketed in Singapore.
Please be reminded that the onus of responsibility to ensure the safety and quality of the traditional medicinal materials rests on you as the importer/seller.