After the outbreak of the COVID-19, the National Pharmaceutical Regulatory Division (NPRA), Ministry of Health Malaysia (MOH) regularly receives inquiries regarding hand sanitizer/hand rub. The following is a list of frequently asked questions and explanations of hand sanitizer.
Q1: What is the category of hand sanitizer product, is it classified as a cosmetic or generic product (Non-Scheduled Poison / OTC; Over-The-Counter)?
A1: Hand sanitizer can be divided into two categories depending on the following conditions:
- a) Cosmetic Products
hand sanitizer for the purpose of hand hygiene ( for general hand hygiene ) is classified as cosmetics. Here are the regulatory requirements that must be met before importing, manufacturing, or marketing cosmetics products:
- i) the product has been notified with NPRA.
- ii) compliance with the requirements stated in the guidelines for Control of Cosmetic Products in Malaysia.
iii) manufactured products that meet the requirements of Good Manufacturing Practices (APBs) for cosmetic or equivalent products.
- b) Generic Products (Non-Scheduled Poisons / OTCs)
Hand sanitizer/hand disinfectant/hand surgical scrub used in health facilities for use by health practitioners before or after performing treatment procedures is classified as a generic product (Non-Scheduled Poison / OTC). The following are the regulatory requirements that must be met before importing, manufacturing, or marketing OTC products:
- i) the product is registered with NPRA (with MAL registration number).
- ii) compliance with the registration requirements stated in the drug Registration Guidance Document (DRGD).
iii) the indication sought based on the evidence documented in references such as standard pharmacopeia / standard pharmaceuticals reference and so on.
- iv) products manufactured on-premises that comply with the Good Manufacturing Practices (APB) requirements for pharmaceutical products (subject to approved dosage forms).
Q2: If my product is categorized as cosmetics, what should I do before importing, manufacturing, or marketing the product?
A2: The company must first notify the National Pharmaceutical Regulatory Division (NPRA), Ministry of Health (MOH). These notifications can only be done online using the QUEST3 + system.
The notification procedure can be found on the Guidelines for Control of Cosmetic Products in Malaysia (available for download from NPRA’s official portal, www.npra.gov.my).
In general, the notice period for cosmetic products is 1 day. However, the notification holder company is reminded to ensure that all documents especially regarding safety, quality and product effectiveness are available for further NPRA verification, if necessary. Failure to comply with this may result in the rejection or cancellation of the notification. For revoked notifications, the product is no longer allowed to be in the market.
Q3: What does a cosmetic product notification mean? Does this mean that my product has been approved by MOH?
A3: Notification means the declaration of compliance by the holding company to the rules, requirements, and guidelines set for cosmetic products. As such, the company takes the responsibility to ensure that the product is evaluated and made safe, quality, and effective before it is marketed. Therefore, it is not a form of approval by MOH. Informed Products will be monitored from time to time and regulatory actions will be taken against products that do not comply with the rules.
Q4: What active ingredients should be in hand sanitizer formulations that are classified as cosmetic products?
A4: Hand sanitizer for certified cosmetics should contain at least 60% alcohol (ethanol or ethyl alcohol). For non-alcohol based sanitizers, sufficient documentation and scientific evidence is required to support the claims made on the label. The failure of the company to submit supporting documents within the stipulated period will result in the refusal or cancellation of the notice. For revoked notifications, the product must be withdrawn from the market.
Q5: What are the permitted claims for hand sanitizer classified as cosmetic products?
A5: Hand sanitizer classified as cosmetics is for hygiene purposes. However, antibacterial claims are also allowed for cosmetic products as additional claims. However, claims such as disinfectant, antiseptic, antimicrobial, antivirus, antifungal, virucidal, reference to specific bacteria, or germicidal causes are not allowed for cosmetic products.
Q6: How to check if a product has been certified or registered with NPRA?
A6: Product notification/registration status checks can be made on the NPRA official portal www.npra.gov.my or through the NPRA Product Search application.
Q7: Are disinfectants used in tools or surfaces / workplaces also classified as cosmetic products?
A7: No. Products disinfectant used to disinfect the poultry or disinfecting medical devices are classified as medical device products. The product must obtain approval from the Medical Devices Authority (PBPP) before being allowed to go on the market. Products disinfectant used to disinfect all types of surfaces ( surfaces ) or the workspace is also classified as a general-purpose product ( general consumer product ).
Q8: What is the recommended use of hand sanitizer for users?
A8: Hand sanitizer is advised to use only when there is no soap and water. Handwashing with the right soap and technique for 20 seconds is very effective in maintaining hygiene while also helping to prevent the spread of diseases such as COVID-19.
Q9: If I have adverse effects or unwanted effects of using hand sanitizer, where can I report?
A9: Complaints of adverse effects or unwanted effects may be forwarded to [email protected] .
Source: Q & A Hand Sanitizer
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