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  Licensing (Manufacturer, Importer and Wholesaler)

According to the Controls of Drugs and Cosmetics Regulations 1984, any company that want to manufacture, import or wholesale any registered products need to have Manufacturer’s Licence, Import Licence or Wholesale Licnese. Licencing unit, Centre for Compliance and Licensing (CCL) involves in the activity of issuance of Licence.

 

Type of Licenses

Type of Licenses Activity
Manufacturer’s Licence Licensed Premises is allowed to:
Manufacture registered products and to sell by wholesale or supply their products.
Import Licence Licensed Premises is allowed to:
Import and sell by wholesale or supply registered products.
Wholesaler’s Licence Licensed Premises is allowed to:
Sell by wholesale or supply registered products.


Application Forms

  • Borang BPFK-413:  Application for Licence for Registered Products (Manufacturer’s Licence, Import Licence, and Wholesaler’s Licence)

For any further enquiries, please refer to FAQ : Manufacturer’s, Import & Wholesaler’s Licence Application


Additional List of Licence for Registered Products

 

Additional list of Licence are issued based on the application submitted when the products are newly registered, changing of manufacturer or importer or any registered left out products from the products list of Manufacturer’s License and Import Licence.
 
When submitting the application form for Additional List of Licence for Registered Products the documents that should be attached together are a copy of Manufacturer’s Licence/Import Licence, a copy of DCA Approval Letter/DCA Meeting Result.
 
If company want to apply to add in the new registered products/ left out registered products into the Manufacturer’s Licence/ Import Licence, company can download borang Senarai Keluaran (tambahan) Lesen Keluaran Berdaftar.

 




 
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