The legislation governing the control of homoeopathic medicines 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.
Currently, homoeopathic medicines 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 homoeopathic 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 contain any Western medicines;
- 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.
Dealers must ensure that all health claims and information associated with the products are sufficiently supported and be submitted to HSA as and when required. Otherwise, all unsubstantiated health claims and information will be considered misleading and must be removed from the product materials.
Homoeopathic medicines are subject to medical advertisement control. Find out more about medical advertisements and sales promotion.
If the Homoeopathic medicines contain substances listed 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 necessary Convention on the International Trade in Endangered Species of Wild Fauna and Flora (CITES) import/export permits.
Table 1: Toxic Heavy Metal Limits
|Substance||Permissible limits||Revised limits
from 1 Sep 2019#
|Arsenic||5 ppm||5 ppm|
|Lead||20 ppm||10 ppm|
|Mercury||0.5 ppm||0.5 ppm|
# For existing products imported/locally manufactured 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 homoeopathic medicines selling in Singapore should not exceed the revised limits.
Additional Requirements for Homoeopathic Medicines Containing Animal Parts (updated February 2018)
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