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Regulatory Guidelines on Importation of Medicinal Products into Singapore
24 August 2012
All medicinal products imported or sold in Singapore are required to be licensed by the Health Products Regulation Group of the Singapore Health Sciences Authority (HSA). Under the Medicines Act, a medicinal product is defined 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 anesthesia or for contraception.” To commence activities in Singapore, a product license must be obtained in advance by a locally-registered company that is responsible for the safety, quality and efficacy of the product.
Import License for Medicinal Product (for Authorized Agent)
An authorized local importer of medicinal products which does not hold the relevant product license(s) may apply to the HSA for an Import License.
The importers must be able to demonstrate their compliance with HSA’s Good Distribution Practice (GDP) standard. The GDP standard is a quality assurance system which ensures that medicinal products quality is maintained during storage and distribution as required by the marketing authorization or product specification. Importers and wholesale dealers of medicinal products are subjected to audit by the regulatory inspectors of the HSA. The products authorized for importation will be listed in the license.
Importers who are not product license holders or authorized agents can also obtain import licenses on consignment basis.
The license allows the import of a registered medicinal product on a per consignment basis after the importer has satisfied the HSA that the product to be imported is equivalent to the medicinal product registered in Singapore. However, pharmacy and prescription medicines can only be imported and sold under the direct supervision of a registered pharmacist holding a valid Poisons License. If the products imported are for resale, the applicant will need a Wholesale Dealer’s License for Medicinal Products.
Wholesale Dealer’s License for Medicinal Products
Wholesale dealing is defined under the Medicines Act as selling a product to a person who buys it for the purpose of reselling it in the course of a business carried on by that person where sale is not by the licensed manufacturer. A Wholesale Dealer’s License for Medicinal Products is required by the wholesale dealer and a further license is required for the wholesale dealing of controlled drugs.
Compliance with HSA’s GDP standard is necessary before the license can be granted.
Importation of an Unregistered Medicinal Product on Named-Patient Basis
Section 66(2)(i) of the Patents Act provides that it is not an infringement of a patent in Singapore to import, dispose of, offer to dispose of, or use a patented pharmaceutical product by or on a specific patient in Singapore where special approval has been granted by the HSA specifically for the import of that product for use by or on that patient and the product was produced by or with the consent of the patent proprietor (conditional or otherwise) or any person licensed by him whether in Singapore or outside of Singapore.
Special approval can be obtained from the HSA Health Products Regulation Group for the importation 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 six 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.
Importation of Medicinal Products for Re-Export
HSA’s approval is required for the importation of medicinal products into Singapore where the intention is to export these products to other countries.
Each consignment must be imported within six months of the approval date. Currently, no fee is charged for obtaining approval. However, the consignment must be exported from Singapore within two years from the date of import.
In addition to the above-mentioned licences, license holders are also required to obtain the following licences when dealing with restricted or controlled substances i.e.: ‘Form A’ Poisons License; authorization to import restricted/psychotropic substances; license to export psychotropic substances; license to import/export controlled drugs; and license to sell controlled drugs by way of wholesale; to ensure compliance with all the relevant legislative and regulatory requirements.
patrick mirandah co. (s) pte ltd
1 Coleman Street
#07-08 The Adelphi
Singapore 179903
T: +65 6336 9696
F: +65 6338 3739
E: singapore@mirandah.com
W: www.mirandah.com
