Many of us today take a lot of pride in using imported cosmetic product and also consuming imported medications. But have any one of us wondered how these products enter Malaysia? It is not as straight forward as some of us may think. This article is written with the hope to increase the public’s awareness regarding importation of drug and also cosmetic product.
In general, importation of drug into Malaysia is controlled by the Poisons Act 1952 and Control of Drugs and Cosmetics Regulations 1984 to ensure ‘Controlled Medicines” are imported by licensed pharmacists and to ensure medicines imported are safe, efficacious and of quality.
Before any drug can be considered to be imported into Malaysia, it must first be registered with the Drug Control Authority. Public can check whether a product is registered or not by contacting the National Pharmaceutical Control Bureau at 03-78835400 or search the website http://www.bpfk.gov.my/ . After the product is registered, the importer has to apply for an import licence to import the registered product.
Under the Poisons Act 1952, poisons means any substance listed in the first column of the Poisons List. You need an appropriate licence to import poisons. Type A license is for a licensed pharmacist to import all poisons . A type B license can be issued to any person deemed proper or fit by a licensing officer to import industrial chemicals controlled as poisons and a Type E licence to import sodium hydroxide. Application of any of the above license can be done through the Pharmacy Enforcement Division (Cawangan Penguatkuasa Farmasi). Any person found guilty of committing offences under this Act, is liable to a fine not exceeding RM 5000 or imprisonment not exceeding 2 years or both.
Starting this year (2008) under the Control of Drugs and Cosmetics Regulation 1984 importer must notify the DCA the cosmetics they intend to put in the market. Prior to this cosmetics also need to be registered with DCA, This is in-line with the harmonization requirement amongst ASEAN countries. For any query, don’t hesitate to call the local Pharmacy Enforcement Division near you.
© Sabah State Pharmacy Enforcement Branch
In general, importation of drug into Malaysia is controlled by the Poisons Act 1952 and Control of Drugs and Cosmetics Regulations 1984 to ensure ‘Controlled Medicines” are imported by licensed pharmacists and to ensure medicines imported are safe, efficacious and of quality.
Before any drug can be considered to be imported into Malaysia, it must first be registered with the Drug Control Authority. Public can check whether a product is registered or not by contacting the National Pharmaceutical Control Bureau at 03-78835400 or search the website http://www.bpfk.gov.my/ . After the product is registered, the importer has to apply for an import licence to import the registered product.
Under the Poisons Act 1952, poisons means any substance listed in the first column of the Poisons List. You need an appropriate licence to import poisons. Type A license is for a licensed pharmacist to import all poisons . A type B license can be issued to any person deemed proper or fit by a licensing officer to import industrial chemicals controlled as poisons and a Type E licence to import sodium hydroxide. Application of any of the above license can be done through the Pharmacy Enforcement Division (Cawangan Penguatkuasa Farmasi). Any person found guilty of committing offences under this Act, is liable to a fine not exceeding RM 5000 or imprisonment not exceeding 2 years or both.
Starting this year (2008) under the Control of Drugs and Cosmetics Regulation 1984 importer must notify the DCA the cosmetics they intend to put in the market. Prior to this cosmetics also need to be registered with DCA, This is in-line with the harmonization requirement amongst ASEAN countries. For any query, don’t hesitate to call the local Pharmacy Enforcement Division near you.
© Sabah State Pharmacy Enforcement Branch
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