Industry Guide to Set Up a Pharmaceutical Business in Malaysia

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Starting a Pharmaceutical Business in Malaysia

Pharmaceutical business are on the rise like the rest of any businesses we see in Malaysia. The demand on the pharmaceutical industry are getting higher along with international investor keeping their close eye towards the pharmaceutical business in Malaysia.
Before starting a pharmaceutical business in general, you need to know there are many rules and regulations which needed to followed closely in order to successfully run your own pharmaceutical business.

In this article we look at the information on the pharmaceutical business and what you need to get started.

What is a Pharmaceutical Business

Pharmaceutical business is a company that has the license to develop, research, market, or distribute drugs within the healthcare factors. These businesses can either deal in overall medication or any specific brand-medication. Businesses like this are subjected to several laws and regulations when it comes to testing, patenting, and marketing these drugs, especially when it comes to drugs prescriptions to the public.
There are five categories of pharmaceutical products in Malaysia. These are:
• Prescription medicine
• Traditional medicine
• Health supplements
• Herbal supplements
• OTC medication

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The Business Registration Process

Before you begin, every pharmaceutical businesses in Malaysia must either be a manufacturer or seller of pharmaceutical products. Although Malaysia’s business registration process is pretty straightforward but still will cause confusion if you’re not familiar with the rules and regulations.
There are some rules and regulations apply differently depending the nature of your role:

Local Investor
– Obtain approval from the Drug Control Authority for the products you intend to provide to the consumers.
Contact BossBoleh to help you work through the process and help you with anything you’re unclear about setting up a pharmaceutical business.

Foreign Investor
– Register your business with the SSM (Suruhanjaya Syarikat Malaysia)
– Gather all necessary documents needed and submit an application to the Companies Commission of Malaysia
whom is the regulating authority for all business in Malaysia. This is the important steps to avoid operating your business illegally in Malaysia.
– Having registered business address which is not just a PO Box address.
– Having minimum of two Malaysian residents director who are over the age of 18. (these individuals must have NO history of bankruptcy in the past)
– You may require a company secretary depending on your business structure.

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Obtain relevant Licenses and Permits

As a pharmaceutical business owner, you’ll need to follow all law and regulations by the Control of Drugs and Cosmetics Regulations 1984.
The act defines that every drug needs to be registered in Malaysia.
The National Pharmaceutical Control Bureau will process these applications and issue the following licenses:
• Wholesaler’s License
• Importer’s License
• Manufacturer’s License

The regulations, however, do not apply to the following products:
• Non-medicated medical and contraceptive devices.
• Non-medicated bandages, surgical dressings, plaster and dental fillings.
• Diagnostic agents and test kits for laboratory use.

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