Chinese Proprietary Medicines
Import Licence and Wholesale Dealer’s Licence for Chinese Proprietary Medicines (CPM)
Regulatory Guidelines and Standards
Import Licence for Chinese Proprietary Medicines (CPM)
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.
In streamlining the application process, with effect from April 2017, companies that intend to import CPM can now apply for CPM product listing first before proceeding with the application for Import Licence for CPM.
Companies applying for the Import Licence for CPM would need to demonstrate their compliance with HSA's GDP standard. Issuance of Import Licence for CPM is subject to the approval of CPM product listing and the satisfactory close-out of GDP audit.
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 (CPM)
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 CPM to others for the purpose of resale will have to apply for a Wholesale Dealer's Licence for CPM.
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 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CPMs which have been approved for product listing and are not allowed to deal in CPMs of which the product listings are no longer valid.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 (GDP) is a quality system which ensures that 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 CPM are required to comply with HSA's GDP requirements to ensure that CPMs are handled, stored and distributed in a proper manner to assure their quality and integrity throughout the supply chain. The HSA's auditors will audit the company in accordance with the HSA Guidance Notes On Good Distribution Practice.
REVISION OF GUIDANCE NOTES ON GOOD DISTRIBUTION PRACTICE
The Health Sciences Authority (HSA) reviews and revises the Guidance Notes on Good Distribution Practice as needed to provide clarity to the existing requirements.
For easy reference, the latest version of Guidance Notes with track changes is available at the following hyperlink:
If further clarification(s) is/are required on the revised Guidance Notes on Good Distribution Practice, please write to us here or contact us at Tel: 6866 1111.