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 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.
In the event that a homoeopathic product contains any poisons or is labelled to contain any poisons listed in the Poisons Act, any person unless exempted under the Poisons Act, would require a Form A poisons licence, please refer to: http://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/Manufacturing_Importation_Distribution/Overview/Audit_and_Licensing_Of_Importers_Wholesale_Dealers_and_Exporters/Poisons_Form_A_Poisons_licence.html
Any person dealing with poisons should comply with the requirements of the Poisons Act and its Rules, and should ensure that the sale of the poison is effected in a registered retail pharmacy and by or under the supervision of a registered pharmacist.
In addition, the sale of any poison included in the Third Schedule will require a prescription given by a registered medical practictioner, dentist or veterinary surgeon or upon a prescription dispensed by a qualified pharmacist on a licensed premise.
Homoeopathic medicines 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 Homoeopathic Medicines Containing Animal Parts
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