Malaysia

I. HEALTH SUPPLEMENTS

Health supplements are defined in the Drug Registration Guidance Document (DRGD) as “any product that is used to supplement a diet and to maintain, enhance and improve the health function of human body. It is presented in small unit dosage forms (to be administered) such as capsules, tablets, powder, liquids and shall not include any sterile preparations (i.e. injectables, eyedrops).” Supplements may contain vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, other bioactive substances, and substances derived from natural sources (including animal, mineral and botanical materials in the forms of extracts, isolates, concentrates, metabolite). Synthetic sources of ingredients may only be used where the safety of these has been proven.

Health supplements containing plant substances not commonly consumed as food or used as food ingredients will be regarded as traditional products instead. This applies for example to food supplements containing spirulina, chlorella, royal jelly, bee pollen, aloe vera juice, noni juice and extract of chicken with herbs. Because of the strict separation between health supplements and traditional preparation, certain plants, animal parts or mineral substances of natural origin combined with vitamins and amino acids may not be available for registration.

In the event the manufacturer is uncertain about classification of the concerned product, an application for classification can be submitted with the National Pharmaceutical Control Bureau (Subdivision of the National Pharmaceutical Regulatory Agency).

Health Supplements cannot include:
- Any product as a sole item of a meal;
- Any injectable and sterile preparation;
- Any cells, tissues, organs or any substance derived from the human body;
- Any substance listed in the Schedule of the Poison Act;
- Any other route of administration other than the oral route.

II. REGISTRATION OF HEALTH SUPPLEMENTS IN MALAYSIA

(i) Type of registration

Health supplements and traditional products require registration as pharmaceutical products/registered drugs with the National Pharmaceutical Regulatory Agency (NPRA).

(ii) Applicant

The applicant, or Product Registration Holder (PRH), needs to be a locally incorporated company registered with Companies Commission of Malaysia and having a business scope related to health/pharmaceutical products. The local agent will be the holder of the registration certificate and is responsible for all matters in relation to the registered product.

(iii) Procedure

Submissions needs to be done online via Quest on the National Pharmaceutical Regulatory Agency website. All data and information including supporting documents for product registration such as certificates, letters and product labels shall be in English or Bahasa Malaysia.

The registration procedure exists of either a ‘full evaluation’ or an ‘abridged evaluation’ depending on the claims made for the health supplement.

The following timeframes apply for the evaluation of health supplements and natural products. To be calculated from the date of final submission of the application.

(iv) Payment

Fees apply for the registration of a product, but also for the membership to Quest (online registration), for distribution licenses (manufacturer, import, wholesale), modifications to the registration, the issuing of certificates and the request of a product classification.

(v) Outcome

If the evaluation is positive a registration number will be awarded (MAL number). The registration remains valid for a period of 5 years. Applicants needs to comply with the conditions imposed upon approval and are responsible for the maintenance of the product in terms of quality, safety and efficacy throughout the validity period of registration. The applicant needs to submit re-registration within the six months prior to expiry through the submission of the Re-registration Application Form and the payment of a processing fee. Failing to do so will result in the need for a new registration satisfying all the procedural requirements.

In case of rejection, an appeal can be brought with the Ministry of Health within 14 days from the date of the notification of the Authority. Re-submission of a rejected application shall not be allowed for 2 years after the rejection. However, if the product is registered in the reference countries, submission of application can be made earlier.

(vi) Modifications

Extensive guidance exists on the modification of certain particulars in the registration of a health supplement/natural product (e.g. changes to the label). All changes require approval from the NPRA. Changes to the active substance may require a new application.

The NPRA has specific dossier requirements. Information such as product name, dosage form, recommended daily dose, active ingredients, product formula, packing details, manufacturer etc. is required.

III. CONTENT AND COMPOSITION HEALTH SUPPLEMENTS IN MALAYSIA

A list of active ingredients including nutrients, plants and other substances can be consulted on the NPRA website. Maximum levels for vitamins and minerals and a list of prohibited/restricted excipients are provided in Appendix 6 of the DRGD.

IV. MANDATORY LABELLING REQUIREMENTS OF HEALTH SUPPLEMENTS IN MALAYSIA

The general labelling requirements, consumer medication information and substance specific labelling requirements are set under Appendix 19 of the DRGD.
Appendix 20 of the DRGD sets out specific labelling requirements for specific substances such as alfalfa, arginine, bee pollen, chitosan, Boswellia serrata.

Some mandatory labelling requirements include:
The product name
Dosage form
Name and strength of the active ingrediens
Registration information
Batch number
Manufacturing and expiry date
Storage condition
Warnings
Manufacturer information
Pack sizes (unit/ volume) 

Recommended daily allowance (RDA) for vitamins/  multivitamins/ mineral preparations. Labels should contain the mandatory information in Bahasa Malaysia or English. Other languages may be present as well.

Some mandatory labelling requirements include:

• the product name
• dosage form
• name and strength of the active ingrediens.
• Registration information
• Batch number
• Manufacturing and expiry date
• Storage condition
• Warnings
• Manufacturer information
• Pack sizes
• Recommended daily allowance for vitamins/multivitamins/mineral preparations

V. CLAIMS USED IN HEALTH SUPPLEMENTS

Pursuant to Appendix 4 of the DRGD, a health supplement claim refers to the beneficial effects of consuming health supplements to promote good health and well-being (physical and mental) by providing nutrition, enhancing body structure/ function, relieving physiological discomfort and/or reducing the risk of health related conditions or diseases.

Three types of claims are distinguished;

(i) General or Nutritional Claims, e.g. ‘Supports healthy growth and  development’, ‘Nourishes the body’, ‘Relieves general tiredness, weakness’, ‘Helps to maintain good health’, ‘For energy and vitality’, ‘For strengthening the body’;

(ii) Functional Claims, e.g. ‘Vitamin A helps to maintain growth, vision and tissue development’, ‘Vitamin D helps in normal development and maintenance of bones and teeth.’;

(iii) Disease Risk Reduction Claims, e.g. ‘Helps to reduce risk of osteoporosis by strengthening bone’, ‘Helps to reduce the risk of dyslipidaemia’.

All claims made for health supplements shall:
i) be consistent with the definition of HS;
ii) enable consumers to make an informed choice regarding products;
iii) not be misleading or false;
iv) support the safe, beneficial and appropriate use of the product;
v) maintain the level of scientific evidence proportional to the type of claims;
vi) be for health maintenance and promotion purpose only
vii) not be medicinal or therapeutic in nature, such as implied for treatment, cure or
prevention of disease.

The definition, wording, criteria for use and required evidence for General or Nutritional Claims, Functional Claims (medium) and Disease risk reduction (high) are listed in Appendix 6 of the DRGD.

A list of authorized claims for specific substances is provided in Appendix 6 of the DRGD. The inclusion, however, does not relief the applicant from the obligation to provide evidence. Neither is the list exhaustive, meaning that other claims will be examined.

In order to make a general or functional claim, the health supplement must contain at least 15% of the Codex Nutrient Reference Values per daily dose for of the vitamin(s) and/or mineral(s). In case of lower amounts, the claim can be used if there is evidence supporting the claim.

The amounts necessary for the use of disease risk claims depends on the substantiating evidence.