Traditional Medicines, Medicated Oils and Balms
The legislation governing the control of Traditional Medicines (TM) and Medicated Oils and Balms (MOB) 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. The ingredients and labelled uses have to be supported by the relevant TM references.
MOB refers to any external medicated embrocation, medicated cream, ointment or inhalant which is used mainly for soothing purposes and 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;
Currently, TM and MOB 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 TM and MOB 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 contain any ingredients listed in ASEAN Guiding Principles for Inclusion into or Exclusion from the Negative List of Substances for Traditional 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.
- Have the compositions and quantities of all ingredients of the products printed in English Language on the product labels and cartons.
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.
TM and MOB are subject to medical advertisement control. Find out more about medical advertisements and sales promotion.
If the TM or MOB contains 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 TM and MOB selling in Singapore should not exceed the revised limits.
Additional Requirements for TM and MOB Containing Animal Parts (updated February 2018)
File Size: (176 Kb)