Beginner’s Guide on Starting a Pharmaceutical Business in Malaysia
Home to many booming and thriving businesses, you’ll find industries of all sorts have made a home and a name for themselves here in Malaysia. From food to travel, retail, manufacturing, telecommunications, and more, Malaysia is the place to be in Asia if you want to launch a successful company. There is a market for just about anything in Malaysia. Some industries are seasonal while some are always in demand and here to stay.
One example of an industry always in demand is the pharmaceutical business. In Malaysia, pharmaceutical companies fall into the category of small and medium-sized companies. Larger multinational corporations such as Pfizer, Schering Plough, Novartis and more are licensed importers. In the past couple of years, the pharmaceutical industry in Malaysia has seen a boom as more and more investors, especially on an international level, have shown a keen interest in the business in this country.
If you have been thinking of starting a pharmaceutical business, then this guide to company registration in Malaysia is what you need.
What Is a Pharmaceutical Business?
Pharmaceutical business is a company that has the license to develop, research, market, or distribute drugs within the healthcare context. These businesses can either deal in generic medications or brand-specific products. Such companies will be subject to several laws and regulations when it comes to testing, patenting, and marketing these drugs, especially prescription drugs, to the public. There are five categories of Pharmaceutical products in Malaysia. These are:
- Prescription medicine
- Traditional medicine
- Health supplements
- Herbal supplements
- Over the counter medication
In Malaysia, the National Pharmaceutical Control Bureau regulates the pharmaceutical industry. It is the main authority responsible for overseeing and ensuring the efficacy and safety of all products sold and manufactured within the local Malaysian market. The pharmaceutical industry also falls under the regulation of the Control of Drugs and Cosmetics Regulations 1984. Under regulation 7(1) of the Control of Drugs and Cosmetics Regulations 1984, a product that is sold, supplied, manufactured or imported must be a registered product. These regulations also stipulate that a product as a drug in a dosage unit or otherwise which is intended to be used wholly or mainly by being administered to one or more humans or animals for medicinal purposes.
One of the benefits of starting a pharmaceutical business in Malaysia is how the industry is part of the National Pharmaceutical Control Bureau. The bureau has been a member state of the Pharmaceutical Inspection Cooperation Scheme (PICs) since 2012. Since becoming a member, Malaysia has seen a boost in investments within the pharmaceutical field. This is mainly because the PICs are represented by well-known international pharmaceutical authorities.
The Business Registration Process
You’ll be pleased to know that the business registration process in Malaysia is fairly straightforward. Before you commence, every pharmaceutical company in Malaysia must either be a manufacturer or seller of medical products.
While straightforward, the business registration process can still cause confusion if you are unfamiliar with the local laws and regulations. This is especially more so when it comes to certain businesses like pharmaceutical businesses. Investors who wish to incorporate and set up a pharmaceutical company in Malaysia will need to obtain approval for the products they intend to provide to Malaysian consumers. The Drug Control Authority issues this approval. As your corporate service provider, 3E Accounting can offer guidance to help you work through this part of the process and clarify anything that is unclear.
Foreign investors benefit greatly from the help of Malaysia company registration specialists like 3E Accounting. With years of industry experience and knowledge, we’ll be able to walk you through the entire registration process in no time. Also, we know how eager you are to start your business. Once we have helped you gather your documents, we will submit an application to the Companies Commission of Malaysia.
The Suruhanjaya Syarikat Malaysia is the regulating authority for all businesses in Malaysia. You should register with the SSM or your business will be at risk of operating illegally in the country.
You will also need to have a registered business address that is not just a PO Box address. Your company also needs a minimum of two resident directors who must be at least 18 years old. These individuals must not have been bankrupt in the past. Depending on your business structure, you may also require a company secretary for your business. 3E Accounting will be able to assist with this one too.
Licenses and Permits You Need to Acquire
Once again, when starting a pharmaceutical business here in Malaysia, you need to abide 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.
If you need further assistance on starting your pharmaceutical business, contact 3E Accounting. Our dedicated team of specialists will be here to assist you from start to finish so starting your business will never have to be a major cause for headache on your part. Let us help you handle the paperwork so you can focus on where it matters the most: Launching your business.