Submission to the Ministry of Health for classification.

Classifications are based on the submitted packaging and ingredient list.

It is the first step before more in-depth details are required. It is a great way to figure out which registration a manufactured or imported product needs to take.

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.

* For information on Food refer to – Drug Intephase products, please refer to subtitle ‘Regulatory Information’ > ‘Other guidelines’ > ‘Classification decision tree’ for further details.

Cosmetics are products which do not have any indications for health benefit use on packaging as well as advertising materials. These products are usually solely for external use only.

The company or person responsible for placing a cosmetic product in the local market must notify the Director of Pharmaceutical Services (DPS) through the National Pharmaceutical Control Bureau (NPCB) prior to market, manufacture or import a cosmetic product. This notification process will allow the NPCB to gather adequate information on the cosmetic products that are placed in the local market.

It is an offence for anyone to manufacture or import a cosmetic product without prior notification to the DPS. (NPRA 2020)

Supplements are products which are intended to “supplement” the diet taken in forms such as pills, capsules, tablets, liquids or powders and not represented as a conventional food or as a sole item of a meal or the diet.

As the number of active ingredients increases so does the cost due to the increased complexity of evaluation.

Uniquely Malaysia supplement registration framework is more vigorous than other markets requiring prior registration before sale. Compared to USA where it is self regulated and at time almost similar to a food. Another key difference is the accompanying advertising act which disallows any reference to organs and diseases. Such as CoEnzyme Q 10 in Australia may show a heart in Malaysia it is not allowed.

1. Pharmaceutical products containing scheduled poisons.
2. Pharmaceutical products containing non-scheduled poisons (OTC)
   Includes:
   + Medicated plaster with medicines
   + Antiseptic/ Disinfectants for use on the human body
   + Diagnostic agents for human use (in vivo)
   + Dietary supplement e.g. Probiotics, Chitosan
3. Traditional products
   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
4. Veterinary products
   Includes:
   + Oral solution, oral suspension & emulsions
   + Granules
   + Paste
   + Water soluble powder
   + Injectable
   + Powder for injection
   + Oral powders
   + Capsule, tablet
   + Topical ophtalmic and otic products