Regulatory Guidelines and Standards
Import Licence for Chinese Proprietary Medicines
This licence is issued under the Medicines Act to allow companies to import Chinese Proprietary Medicines (CPM). The CPM must be listed and approved for sale in Singapore prior to importation. Companies applying for the Import Licence for CPM would need to demonstrate their compliance with HSA's GDP standard.
If the products are imported for the purpose of selling to others for re-selling, the company would need a Wholesale Dealer's Licence for Chinese Proprietary Medicines.
Wholesale Dealer's Licence for Chinese Proprietary Medicines
Wholesale dealing is defined under the Medicines Act as selling (a product) to a person who buys it for the purpose of selling or supplying it in the course of a business carried on by that person except that it does not include any such sale by the person who manufactured it. Therefore, any person (except for licensed manufacturers) who intend to sell approved Chinese Proprietary Medicines (CPM) to others for the purpose of resale will have to apply for a Wholesale Dealer's Licence for CPM. Licensed CPM wholesale dealers can only deal in CPMs which have been approved for product listing and are not allowed to deal in CPMs of which the product listings are no longer valid.
Good Distribution Practice Standard
Good Distribution Practice is a quality system which ensures that medicinal products are stored and handled consistently under appropriate conditions as required by the marketing authorization or product specification so that the quality of the products will be maintained during storage and distribution.
Importers and Wholesale Dealers of Medicinal Products are required to comply with the HSA GDP standard. The Regulatory Inspectors of HSA will audit the company in accordance with the HSA Guidance Notes On Good Distribution Practice.
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