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Guide to Set Up a Pharmaceutical Company in Malaysia

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, has shown a keen interest in the business in this country.

To set up a pharmaceutical company in Malaysia, it is necessary to be familiarized with all the regulations which have been put in place by various agencies, and acquiring the necessary business permits is essential and compulsory before the business can operate legally in this country.

In Malaysia, pharmaceutical companies fall into the category of mainly small and medium-sized companies, while larger multinational corporations such as Pfizer, Schering Plough, Novartis and more are mainly licensed importers.

 

The Pharmaceutical Industry

The pharmaceutical industry in Malaysia is regulated by the National Pharmaceutical Control Bureau, the main authority which is responsible for overseeing and ensuring the efficacy and safety of all products which are sold and manufactured within the local Malaysian market.

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, namely because the PICs are represented by well-known international pharmaceutical authorities.

All companies who are registered in Malaysia as pharmaceutical companies must either be manufacturers of the medical products, or if they are not manufacturers, then be sellers of the products.

Investors who wish to incorporate and set up a pharmaceutical company in Malaysia will be required to obtain approval for the products they intend to provide to the Malaysian consumers. This approval is issued by the Drug Control Authority, which was established since 1986.

 

What Falls Under the Category of Pharmaceutical Products?

Based on the Malaysian legislation, pharmaceutical products are divided into 5 categories:

  • Prescription medicine
  • Traditional medicine
  • Health supplements
  • Herbal supplements
  • Over the counter medication

 

Licenses for Registered Products

All drugs which are sold by pharmaceutical companies in Malaysia must be registered, and the National Pharmaceutical Control Bureau will process these applications and issue the following licenses:

  • Wholesaler’s License
  • Importer’s License
  • Manufacturer’s License

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. The 1984 act defines 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.

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 which are intended for laboratory use

Are you interested in setting up a company in Malaysia? Contact 3E Accounting’s team of expert consultants who are happy to assist and offer their knowledge and expertise when it comes to business registration in Malaysia. Visit our website or contact us for more information.