Malaysia NPRA Clarifies Regulatory Requirements for Hand Sanitizers

Hand sanitizer for hygiene purpose is classified as cosmetics, which should contain at least 60% alcohol. For alcohol-free sanitizers, sufficient documentation and scientific evidence is required to support the claims marked on the label Antibacterial claims are allowed for hand sanitizer classified as cosmetics

On April 3, 2020, Malaysian National Pharmaceutical Regulatory Agency (NPRA) released a collection of answers to the frequently asked questions about hand sanitizers ^[1]. The collection specifies the categories, regulatory requirements, active ingredients, permitted and prohibited claims, etc. of hand sanitizers.

Category and Regulatory Requirements

Hand sanitizers are divided into cosmetic and generic products depending on their usage and function. The following are the regulatory requirements that must be met before importing, manufacturing, or marketing hand sanitizers.

Category	Usage/Function	Regulatory requirements
Cosmetic Product	Hand sanitizers for general hand hygiene	The product has been notified with NPRA (procedures, dossiers) Comply with the requirements stated in the Guidelines for Control of Cosmetic Products in Malaysia The product must be manufactured in accordance with the Guidelines on Good Manufacturing Practice for Cosmetic or its equivalent
Generic Product (Non-scheduled Poison/OTC)	Hand sanitizers/hand disinfectants/hand surgical scrubs used in health facilities that are to be used by health practitioners before or after performing treatment procedures	The product is registered with NPRA (with MAL registration number) Comply with the registration requirements stated in the Drug Registration Guidance Document (DRGD) The indication sought based on the evidence documented in references such as standard pharmacopeia/standard pharmaceuticals reference, etc. The product must be manufactured in accordance with the Guidelines on Good Manufacturing Practice for Pharmaceutical Products
Non-scheduled Poison/OTC: (Known as Non-Poison or "Over-the-Counter", OTC) Products containing active ingredients which are not listed in the First Schedule under Poisons Act 1952*; and is excluding active ingredients which are categorized under health supplements or natural products or cosmetics ^[2]

Active Ingredients

Hand sanitizer classified as cosmetics should contain at least 60% alcohol (ethanol or ethyl alcohol). Malaysian Minister of Religious Affairs has given the green light for Muslim consumers to use alcohol-based hand sanitizers ^[3].

For alcohol-free sanitizers, sufficient documentation and scientific evidence is required to support the claims marked on the label. The failure of the enterprise to submit supporting documents within the stipulated period will result in the rejection or cancellation of the notification.

Claims

Hand sanitizer classified as cosmetics shall comply with Cosmetic Claims Guideline. Antibacterial claims are allowed for hand sanitizers as secondary claims.

Misleading, improper, not factual, religious, or GMP certification related claims are prohibited. Some examples of prohibited claims commonly observed for hand sanitizer classified as cosmetics are given below.

Prohibited claims for hand sanitizer classified as cosmetics

Disinfectant
Antiseptic
Antimicrobial
Antiviral
Antifungal
Virucidal
Reference to specific bacteria or germicidal causes

*This is not an exhaustive list and subject to review when necessary

Find the English Version of the full Q&A collection here.