Medicine / Traditional Medicine Advertising Permit KKLIU (Malaysia)

In Malaysia, whether a medicine "can be sold" and whether it "can be advertised" are two separate things. Whether it is a prescription drug, an over-the-counter (OTC) medicine, or a traditional medicine, as long as it is promoted to the general public, you must first apply to the Medicine Advertisements Board (MAB; in Malay, Lembaga Iklan Ubat, LIU) under the Ministry of Health and obtain a KKLIU advertising permit before it can be published. A product that is already registered with the Drug Control Authority (DCA) and carries a MAL number is only legally allowed to be marketed; advertising is a separate, independent review. Promoting a product without a KKLIU is illegal even if the product itself is legal.

What KKLIU is and where the law comes from

KKLIU stands for Kelulusan Kementerian Kesihatan Malaysia Untuk Iklan Ubat (Ministry of Health approval for medicine advertising). The legal basis is the Medicines (Advertisement and Sale) Act 1956 (Act 290, revised 1983) and its subsidiary regulations, enforced by the MAB under the Ministry of Health's Pharmaceutical Services Programme. This Act regulates advertisements that make "medical / health efficacy claims" to the public, covering medicines, appliances, treatments and related services.

Which advertisements need a KKLIU (scope)

Any content that promotes a product to the public and encourages its use generally counts as an "advertisement." The scope includes:

• DCA-registered prescription drugs and OTC medicines
• Traditional medicines / natural products (MAL numbers ending in T, such as medicated balms, plasters, herbal teas, etc.)
• Health supplements (ending in N)
• Nicotine replacement products (smoking-cessation lozenges, patches), etc.

The channel does not matter: websites, e-commerce pages, newspapers, television, radio, social media posts, livestreams and KOL sponsored content are all covered. The core idea — registration does not equal permission to advertise.

Special points for traditional-medicine advertising

The most common trap for traditional medicines is turning a "traditional use" into a "disease-curing efficacy." A product registered as a traditional medicine must keep its claims aligned with the traditional use approved at registration and cannot extend into the treatment of diseases in modern medicine. Common mistakes:

• Dressing up ancestral formulas or ancient-method wording as "cures" or "instant relief."
• Citing user testimonials as proof of efficacy.
• Claiming to replace a doctor's prescription or conventional treatment.

Even with a traditional pedigree, once such claims are made to the public they must first pass the MAB; and anything touching the prohibited diseases in the next section will never be approved, no matter what.

The absolute red line: statutory prohibited disease claims

Section 3 of the Medicines (Advertisement and Sale) Act 1956 lists, in a schedule, a set of diseases that no product may claim to the public to prevent, treat, diagnose or improve, and the MAB will not approve such advertisements. The list covers about 20 categories; common ones include:

• Kidney disease, heart disease, diabetes, hypertension
• Cancer, tuberculosis, leprosy, epilepsy, paralysis
• Deafness, asthma, hernia, sexual dysfunction, infertility, venereal disease
• Mental / neurological disorders, drug dependence, etc.

A traditional-medicine or OTC advertisement that hints at "lowering blood sugar," "anti-cancer," "treating hypertension" or "boosting virility" crosses the line directly.

The KKLIU number: must be displayed after approval

Once an advertisement passes review, the MAB issues a KKLIU number (in the format KKLIU + serial number + year, e.g. KKLIU 0213/2013). In practice:

• Every approved advertisement, on every page, must clearly display the KKLIU number.
• The advertisement must also state the name, telephone number and address of the advertiser / promoter.
• Members of the public who see a medical advertisement missing the number can report it to the Ministry of Health.

The validity period of an approval, the submission format and the required documents should follow the MAB's current notices and latest guidance; revising the creative or switching platforms usually requires re-confirming the scope of the approval — do not apply an old number to new content.

Penalties for violations

Under the Medicines (Advertisement and Sale) Act 1956, unlawfully publishing a medical advertisement, upon conviction, carries:

In addition, if the advertisement involves an unregistered product, it may also trigger the heavier sale-related penalties under the Control of Drugs and Cosmetics Regulations 1984, among others.

Frequently asked questions (FAQ)

Q: A traditional medicine already has MAL (T) registration — do I still need a separate advertising approval? Yes. Registration is handled by the DCA for quality and safety; advertising is handled by the MAB; the two are separate. To promote to the public you must first obtain a KKLIU.

Q: What counts as an "advertisement"? Do social posts, livestreams and sponsored content count too? Any content that promotes a product to the public and encourages its use is generally an advertisement — including websites, e-commerce pages, social media, livestreams and KOL sponsored content. To be safe, submit everything for review first.

Q: Where do traditional-medicine ads most easily break the law? By exaggerating a traditional use into disease treatment, or touching the Section 3 prohibited diseases (cancer, diabetes, hypertension, virility, etc.). Claims must stay aligned with the traditional use approved at registration.

Q: Must the KKLIU number always appear on the advertisement? Yes. Every approved advertisement must clearly display the KKLIU number and state the advertiser's name, telephone number and address; a missing number can be reported.

Q: What happens if I advertise without applying? You can be held liable under the Medicines (Advertisement and Sale) Act 1956: a first offence carries a fine up to RM3,000 or 1 year's imprisonment, a repeat offence up to RM5,000 or 2 years; if an unregistered product is involved the penalties are heavier.

Q: Can an advertisement already approved overseas be run directly in Malaysia? No. Overseas approval is not covered by Malaysia's KKLIU; local publication still requires a fresh submission to the MAB.

Self-check checklist

• [ ] The product has completed NPRA / DCA registration (has a MAL number)
• [ ] The ad copy does not touch the Section 3 prohibited disease claims
• [ ] Traditional-medicine claims stay aligned with the approved traditional use and are not exaggerated into efficacy
• [ ] Applied to the MAB and obtained a KKLIU number
• [ ] Every advertisement displays the KKLIU number + advertiser name / telephone / address
• [ ] New creative / new platforms have been confirmed to be within the approved scope

Summary

To advertise medicines and traditional medicines in Malaysia, first pass the MAB to obtain a KKLIU, then publish, and display the number on every advertisement; claims must avoid the disease list in Section 3 of the Medicines (Advertisement and Sale) Act 1956, and traditional medicines must additionally stay within the boundary of "traditional use." Planning "registration" and "advertising approval" separately helps you avoid the most common — and most damaging — penalties.

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Further reading: Malaysia Traditional Medicine MAL Registration Guide, Health Supplement Advertising and the KKLIU Permit, Drug Classification Map: How Western Medicine / Traditional Medicine / Supplements Are Distinguished.

This article is compiled from official sources and is for reference only; actual compliance is subject to the competent authority's latest text and review.