Product Registration

Food & Drink

ProductRegistration1

Food – as defined under the Food Act 1983 and Food Regulations 1985, includes every article manufactured, sold or represented for use as food or drink for human consumption or which enters into or is used in the composition, preparation, preservation, of any food or drink and includes confectionery, chewing substances and any ingredient of such food, drink, confectionery or chewing substances.

This includes food for special dietary use for persons with a specific disease, disorder or medical condition, and food which contain quantities of added nutrients allowable under the Food Act and Regulations.

Product contains 80% or more of food ingredients, singly or in combination, and with equal to or less than 20% of biologically active ingredients of natural products with pharmacological and/or therapeutic properties, the product has to be classified as food and regulated by BKMM.

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Cosmetic / Skin Care

CosmeticS

Please refer to Annex 1, part 2 – Illustrative list by category of cosmetic product.Definition of Cosmetic Product based on the ASEAN Cosmetic Directives.

A cosmetic product shall mean “any substance or preparation intended to be placed in contact with various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with teeth and the mucous membranes of the oval cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and / or correcting body odours and / or protecting them or keeping them in good condition”.

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OTC Health Supplements

ProductRegistrationOver-the-counter (OTC) drugs are medicines that may be sold without a prescription, in contrast to prescription drugs.
Includes:
♦ Anti-dandruff shampoo
♦ Anti-pigmentation preparation
♦ Oral healthcare products with therapeutic claims (eg. Anti-plague) Tooth whiteners containing hydrogen peroxide/ carbamyl peroxide
♦ Medicated plaster
♦ Antiseptics/ Disinfectants for use on the human body
♦ Diagnostic agents for human use (in vivo)
♦ Dietary supplements eg. Probiotics, Chitosan

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Traditional Herbs

A Traditional Medicine means any product employed in the practice of indigenous medicine, whereby the drugs used consist of one or more naturally occurring substances of plant, animal or mineral or part thereof, or in extracted form or non-extracted form, and any homeopathic medicine. (Indigenous Medicine – means a system of treatment and prevention of diseases involving the traditional use of naturally occurring substances.
Includes:
♦ Homeopathic medicines
♦ Ayurvedic medicines
♦ Medicated plaster
♦ Herbal teas
♦ Dietary supplements eg. Spirulina, Chlorella, Royal Jelly, Bee Pollen, Aloe Vera juice, Noni juice, Extract of chicken with
herbs.

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