Do you have a product or medication that you would like to manufacture or distribute in Malaysia? If so, then you must complete the Malaysian Drug Registration process. This blog post will outline what this process entails and include helpful tips on how to get started with your application.
Malaysian drug registration is an important step for any company looking to distribute their product within Malaysia. It is important because it allows companies who are interested in distributing their products within Malaysia are required to be registered. The only exceptions are food products. Even cosmetics need to be registered for notification (NOT)
1. What is Malaysia MAL Registration
Malaysia MAL Registration is used for regulated products used on the skin or eaten. This includes Drugs, Over the Counter Products / Drugs, Traditional Medicines, Veterinary Products and Supplements (Refer to point 5)
2. How to Register for Malaysia MAL
Registration for Malaysia MAL is done through the Quest system. You need to register a USB Token that will be linked to your company. Then you will be able to submit the documents for MAL Registration
3. Benefits of Having a Malaysia MAL Number
MAL Number essential validates your claims on the product. The intended claims need to be highly supported with scientific evidence that your product/drug is able to do as it claims
4. Who Needs a Malaysia MAL Number
Products that have claims generally will fall under MAL or products which use herbal extracts. Other products such as capsules, soft gels and tablets will usually require a MAL number
5. How Long to Get Approval.
Depending on the product minimum of 6 – 9 months based on our experience.
6 . Reading MAL Number
How to identify medicines that are registered with MOH
All medicinal products in Malaysia, including imported medicines, must be registered with the Ministry of Health Malaysia (MOH) before they can be sold or marketed to consumers.
Registered products are guaranteed in terms of Safety, Quality and Efficacy. Registered medicines must carry both registration numbers (ie MAL20125467T) and Meditag Hologram labels on its label or packaging.
A valid registration number begins with “MAL”, followed by 8-digit numbers and ends with an alphabet to indicate their registration category. The categories of registered products are as follows:
A – Controlled medicines
X – Over the counter medicines (OTC)
T – Natural Products/ Traditional Medicines
N – Health Supplements
H – Veterinary Products
In addition, there may be administrative codes used by the National Pharmaceutical Regulatory Agency after the product category. The administrative code is:
C – Contract Manufactured (the product is manufactured by a GMP certified contract manufacturer)
E – For Export Only (FEO) (the product is to be sold for export only and not for sale in the local market)
R – Packed and/or repacked (the product is packed and/or repacked by an approved GMP certified packer and/or repacker)
S – Second source (the product is from a second source/ approved second manufacturer)
Y – Orphan products
Z – Products gazetted as zero-rated under the Goods and Services Tax Act 2014, Goods and Services Tax (Zero-Rated Supplies) Order 2014.
Users can check the registration status of a product through the https://www.npra.gov.my / OR by contacting the National Pharmaceutical Regulatory Agency at 03-78835400.
Furley Bioextracts is a listed Health Supplement and Traditional product manufacture and is an experienced product registrations firm with decades of knowledge under their belts. With over 30+ years in business, they know the ins and outs of Product registration with experience in all sorts of products from food, supplement, cosmetics, traditional medicine and even medical devices.
Contact us today to help you with your products, of course, we take preference to customers who manufacture with us and have preferential pricing as well.
Furley Bioextracts Sdn. Bhd. is a 100% Malaysia grown & owned manufacturing company with ISO22000, ISO13485, HACCP and GMP certification. Our staff has 50 years combined experience, Furleybio can make your ideas a reality. From idea to prototype to finished product, ready-made or customised formula and packaging sourcing, we will assist you every step of the way.
For more information, contact Furleybio via email, [email protected]