Introduction to Malaysia MAL:

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, 质量 and Efficacy. Registered medicines must carry both registration numbers (ie  MAL20125467T) and  Meditag 全息图标签 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 - 受管制药品

X - 非处方药（OTC）

T - 天然产品/传统药物

N - 健康补充剂

H - 兽医产品

In addition, there may be administrative codes used by the National Pharmaceutical Regulatory Agency after the product category. The administrative code is:

C  - 合同制造（产品由获得 GMP 认证的合同制造商制造）

E - 仅供出口 (FEO)（产品仅供出口，不在本地市场销售）

R – Packed and/or repacked (the product is packed and/or repacked by an approved GMP certified packer and/or repacker)

S - 第二来源（产品来自第二来源/经批准的第二制造商）

Y – Orphan products

Z - 根据《2014 年商品和服务税法》、《2014 年商品和服务税（零税率供应品）法令》在公报上公布为零税率的产品。

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.

Ref (Pharmacy Malaysia Government Website)

Conclusion:

富利生物提取物 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.

富利生物提取物 已经营 15 年以上，拥有 50 年以上的生产经验，创造了 10,000 多种配方。获得的认证包括 ISO22000、ISO13485、cGMP、HACCP 和 Halal。

我们与小型微型企业和大型跨国公司合作开发产品。

我们是一家合同制造商、 OEM我们是一家专门从事食品、化妆品、传统产品、胶囊、医疗器械和保健品生产的公司，是业务合作伙伴和指导者。我们为世界各地的客户提供服务，包括亚太地区、欧洲、中东/非洲和北美地区。

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