Regulatory Guidelines and Standards
Import Licence (for Authorized Agent) for Medicinal Products
Under the Medicines Act, importers of medicinal products who do not hold the relevant product licences may apply for an import licence to import registered medicinal products. The Import Licence (for Authorized Agent) for Medicinal Products will only be issued to local importers who have been authorized by the product licence holders to import licensed products on their behalf. The importers must demonstrate their compliance with HSA's GDP standard before the granting of the Import Licence would be considered. The products authorized for importation would be listed in the licence.
If the products imported are for the purpose of selling to others for re-selling, the company would need a Wholesale Dealer's Licence for Medicinal Products.
Wholesale Dealer's Licence 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 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 intends to sell registered medicinal products to others for purpose of resale will have to apply for a Wholesale Dealer's Licence for Medicinal Products. Additional licence is required for the wholesale dealing of controlled drugs. For details on the Wholesale Dealer's Licence of Controlled Drugs, please click here.
The granting of the Wholesale Dealer's Licence would be considered when the company has been audited and found to comply with HSA's GDP standard. Licensed wholesale dealers can only deal in registered medicinal products and are not allowed to deal in medicinal products of which the product licences are no longer valid.
Good Distribution Practice Standard
Good Distribution Practice (GDP) 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, transportation and distribution.
Importers and wholesale dealers of medicinal products are required to comply with the HSA's GDP standard. The HSA's auditors will audit the company in accordance with the HSA Guidance Notes On Good Distribution Practice.
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