Product Licence

All medicinal products imported or sold in Singapore are required to be licensed by the Health Products Regulation Group, Health Sciences Authority. A medicinal product is defined in the Medicines Act as "any substance which is to be used for administration to human beings and animals for the diagnosis, prevention or treatment of ailments including preparations intended for the promotion of health, for anaesthesia or for contraception". The onus of applying for a product licence rests with the licence holder, ie a locally registered company that is responsible for the safety, quality and efficacy of the product.

For list of fees for product licence applications, click here.

Import Licence

• Importers who do not hold product licences may apply for import licences to import registered medicinal products. Pharmacy Only and Prescription Only Medicines should be imported and sold under the direct supervision of a registered pharmacist holding a valid Poisons Licence.
  
  
• Import Licence (On Consignment Basis)
  This licence is issued to importers who are not product licence holders or authorised agents. The licence allows the import of a registered medicinal product on a per consignment basis after the importer has satisfied the licensing authority that the product to be imported is in all respects the same as the medicinal product registered in Singapore. For list of fees, please click here.
  
  
• For any other Import Licence and Authorization to import/export controlled substances, please click here.
  

Special Approval To Import an Unregistered Medicinal Product On Named-Patient Basis

Special approval must be obtained from the Health Products Regulation Group, Health Sciences Authority, for the import of unregistered medicinal products on a named-patient basis. The application must include details of the product to be imported for use and particulars of the importer, the physician responsible as well as the patient to be treated, and submitted to the Therapeutic Products Division (TPD). The consignment of the medicinal product must be imported into Singapore within 6 months from the approval date, unless otherwise stated. Currently, no fee is charged for approval. Both the importer and the physician responsible must maintain proper records on the supply and use of the medicinal product.

Approval To Import Medicinal Products For Re-Export

An approval from the Health Products Regulation Group, Health Sciences Authority, is required for the import of medicinal products with the intention of exporting these products to other countries. Approval is given for each consignment to be imported within 6 months of approval, Currently, no fees is charged for the approval. The consignment must be exported from Singapore within 2 years from the date of import.