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Homoeopathic medicines

Understand the requirements to import, manufacture or sell homoeopathic medicines in Singapore.

What is a homoeopathic medicine

Homoeopathic medicine (HM) refers to a medicine that is formulated for use on the principle of "like cures like". It means any substance used in the system of therapeutics in which a disease is treated by the use of minute amounts of one or more substances which, in their undiluted forms, are capable of producing in a healthy human being symptoms similar to those of the disease being treated. It is prepared to a homoeopathic manufacturing procedure described by a Homoeopathic pharmacopoeia.

Food and supplements of food nature come under the purview of the Singapore Food Agency (SFA). View the interactive Food-Health Product Classification Tree1517 KB for more information.

Is my product a complementary health product (CHP)?

Answer a few questions in our self-help tool to find out if your product is considered a complementary health product (e.g.  Chinese Proprietary Medicine, Health Supplement, Traditional Medicine) in Singapore.

 

You can also get a print-out of your product classification outcome from the tool.Let's go

Want to know more about CHP product classification? Click here for our FAQ.

Regulatory requirements of HM

HM are not subject to approvals and licensing by HSA for their importation, manufacture and sales. HSA prohibits the addition of medicinal ingredients such as steroids in HM. HSA also sets strict limits on toxic heavy metals in these products. Dealers (importers, manufacturers, wholesale dealers and sellers) have the obligation to ensure that their products are not harmful or unsafe, and that they conform with the following guidelines before supplying HM into Singapore.

Toxic heavy metal limits

Toxic heavy metal limits

Your product must not exceed the following heavy metal limits:

Heavy metal Permissible limits
Arsenic 5 parts per million (ppm)
Cadmium 0.3ppm
Lead 10ppm
Mercury 0.5ppm

Microbial limits

Microbial limits

Your product must not exceed the following microbial limits:

Oral products 

Microbe  Microbial limits 

Total aerobic microbial count

Not more than 105 CFU per g or ml 

Yeast and mould count

Not more than 5 x 102 CFU per g or ml

Escherichia coli, Salmonellae and Staphylococcus aureus

Absent in 1g or ml

Topical products 

Microbe Microbial limits 
Total aerobic microbial count Not more than 104 CFU per g or ml
Yeast and mould count Not more than 5 x 102 CFU per g or ml
Pseudomonas aeruginosa and Staphyloccocus aureus Absent in 1g or ml

 

Notwithstanding the limits stated above, it is the obligation of the dealers and sellers to ensure that the microbial content and heavy metals of the product is appropriate and safe when used according to the recommended conditions of use and target users.

Labelling requirements

Labelling requirements

Your product label should include the ingredients and their strengths in English. You are also not allowed to claim or indirectly suggest that the product will prevent, alleviate or cure any of the following conditions:

  1. Blindness
  2. Cancer
  3. Cataract
  4. Drug addiction
  5. Deafness
  6. Diabetes
  7. Epilepsy or fits
  8. Hypertension
  9. Insanity
  10. Kidney diseases
  11. Leprosy
  12. Menstrual disorder
  13. Paralysis
  14. Tuberculosis
  15. Sexual function
  16. Infertility
  17. Impotency
  18. Frigidity
  19. Conception and pregnancy

Dealers must ensure that all health claims and information associated with the products are sufficiently supported and 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. 

Prohibited ingredients

Prohibited ingredients

HM manufactured or imported and sold here cannot contain these ingredients or substances:

  • Amygdalin, pangamic acid or its salts, danthron, suprofen or its salts and rhodamine B.
  • Synthetic drugs.

Transmissible Spongiform Encephalopathy (TSE)

Animal derived ingredients

Transmissible spongiform encephalopathy (TSE) refers to a group of progressive diseases including scrapie in sheep and goats, chronic wasting disease in mule, deer and elk, bovine spongiform encephalopathy (BSE) in cattle, as well as Kuru and Creutzfeldt-Jakob Disease (CJD) in humans.

The infectious agents causing these diseases replicate and cause neurological disorders and eventual death in the infected individuals. There are currently no early diagnostic tests or known therapies for these diseases.

If your product contains animal derived ingredients, you must comply with our TSE guidelines107 KB to minimise the risk of TSE transmission.

Substances from endangered species

Substances from endangered species

If your product contains substances from endangered species listed under the Endangered Species (Import & Export) Act, you should contact the Wildlife Management Group of NParks to obtain the necessary Convention on the International Trade in Endangered Species of Wild Fauna and Flora (CITES) import and export permits.

Advertisements and promotions

Advertisements and promotions

You will require a valid permit from us before publishing any medical advertisement or conducting any sales promotion activity directed at the general public.

Refer to our advertisements and promotions guidelines for more information on what is required before you run any advertisement or promotion for your products.

To complement the traditional medicines, homoeopathic medicines and medicated oils and balms Guidelines, a list of questions and answers on the controls, safety and quality, claims and labelling can be found here88 KB
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