The legislation governing the control of Traditional Medicines (TM) are as follows:
(i) Medicines Act 1975 and its Regulations
(ii) Medicines (Advertisement & Sales) Act
(iii) Sales of Drugs Act and its Regulations
(iv) Poisons Act and its Rules
Please click here for details of legislation.
TM in the local context, refer to Malay and Indian traditional medicinal products. In general, for TM, the ingredients and labelled uses have to be documented by relevant TM references. Currently, TM are not subject to pre-marketing approval and licensing for their import, manufacture and sale in Singapore. Dealers (including importers, manufacturers, wholesale dealers and sellers) are responsible for the safety and quality of the traditional medicines with which they are dealing. They must ensure that their products shall:
- NOT contain any other substances except those stated on the labels;
- NOT contain substances listed in the Schedule of the Poisons Act;
- NOT contain prohibited substances including amygdalin, pangamic acid, danthron, suprofen and rhodamine B;
- NOT exceed the toxic heavy metals limits as specified in Table 1;
- 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 on the labels and packaging materials.
TM are subject to medical advertisement control. Find out more about medical advertisements and sales promotion.
Dealers should contact the Wildlife Section, Agri-Food & Veterinary Authority, 52 Jurong Gateway Road, #14-01, Singapore 608550, Tel: (65) 6805 2992, if the products contain substances listed under the Endangered Species (Import & Export) Act.
Table 1: Toxic Heavy Metals Limits
Additional Requirements for TM Containing Animal Parts
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