2. Product Categories

Ingredients Regulation Overview for Ingredient Manufacturers
Malaysia

This section provides the regulatory definition of the ingredients' categories in scope.

2.1 Pharmaceutical Product

Under the Control of Drugs and Cosmetics Regulations 1984, Regulation 2, “Product” means:  

1. a drug in a dosage unit or otherwise, for use wholly or mainly by being administered to one or more human beings or animals for a medicinal purpose; or 
2. a drug to be used as an ingredient of a preparation for a medicinal purpose.

Under the Sales of Drug Act 1952, Section 2:  

“Drug” includes any substance, product, or article intended to be used or capable, or purported or claimed to be capable, of being used on humans or any animal, whether internally or externally, for a medicinal purpose. 

“Medicinal purpose” means any of the following purposes:  

1. alleviating, treating, curing, or preventing a disease or a pathological condition or symptoms of a disease; 
2. diagnosing a disease or ascertaining the existence, degree, or extent of a physiological or pathological condition;  
3. contraception;  
4. inducing anesthesia;  
5. maintaining, modifying, preventing, restoring, or interfering with, the normal operation of a physiological function;  
6. controlling body weight; and
7. general maintenance or promotion of health or wellbeing.

2.2 Health Supplement

A Health Supplement (HS) refers to any product used to supplement a diet and to maintain, enhance, and improve the health function of the human body. It is presented in small unit dosage forms (to be administered) such as capsules, tablets, powder, and liquids and shall not include any sterile preparations (i.e. injectables, eyedrops). It may contain one or more, or the following combinations: 

1. Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, and other bioactive substances;
2. Substances derived from natural sources, including animal, mineral, and botanical materials in the forms of extracts, isolates, concentrates, and metabolite;
3. Synthetic sources of ingredients mentioned in (1) and (2) may only be used where the safety of these has been proven.

2.3 Veterinary Drugs

The implementation of the regulations on veterinary products applies to all products containing a Schedule poison(s) or not, which are intended to be administered to animals for medicinal purposes as listed in Section 2.1 above.

Dietary/Health Supplements: If the dietary/health supplement has a therapeutic claim or indication, they are considered a non-poison OTC product requiring registration with the Drug Control Agency of the NPRA. Scientific evidence and efficacy data are required for the registration of any new therapeutic claims. If the supplement does not make a therapeutic claim, it is not regulated as a drug and comes under the control of the DVS.

Veterinary premixes: Mixtures of one or more active ingredients, usually in suitable bases, which contain scheduled poisons (substances listed in the First Schedule of the Poison Act 1952) or non-poisonous substances, that are used exclusively in the preparation of animal feed for medicinal purposes. Premixes occur in granulated, powdered, semi-solid, or liquid form and may also occur in pelleted form. Premixes for medicinal purposes are registrable with the NPRA and must not be supplied directly to the end-user (e.g., in farm, home, or self-mixers of animal feed).

2.4 References

1. Drug Registration Guidance Document (DRGD) Third Edition, Seventh Revision, January 2024

https://npra.gov.my/easyarticles/images/users/1153/DRGD%20January%202024/MAIN-BODY-Drug-Registration-Guidance-Document-DRGD-3rd-Edition-7th-Revision-January-2024.pdf

2. Registration Guideline of Veterinary Products (REGOVP) Third Edition, Revised January 2024

https://www.npra.gov.my/easyarticles/images/users/1056/REGOVP_JULY2014_190124-18.pdf