Overview of importer, wholesaler and manufacturer's licences

Understand the licensing requirements before you import, wholesale and manufacture Chinese Proprietary Medicines in Singapore.

Importers and wholesalers

Overview

Your company needs to hold the relevant dealer’s licences to import and wholesale Chinese Proprietary Medicines (CPM) in Singapore.

Import or wholesale of CPM for clinical use

An import licence and a wholesale dealer’s licence are required to import and wholesale CPM products respectively. Your company must comply with the Good Distribution Practice (GDP) standard before these licences are granted to you.

Companies that intend to import CPM for local clinical use in Singapore are required to obtain at least an in-principle approval for CPM product listing application before applying for import licence for CPM. Issuance of the import licence for CPM is subject to the approval of CPM product listing and the satisfactory close-out of GDP audit.

If you have outsourced the import and wholesale activities including the invoicing to another company, you do not need to hold these licences yourself. The above licensing requirements and GDP compliance apply to the company that you have outsourced the activities to.

Import of CPM solely for export or re-export to another country

Companies which are importing CPM solely to export/re-export to another country do not need to apply for an import licence for CPM. However, you will need to apply for an import for re-export of CPM permit.

Import or wholesale of unlisted CPM for use as clinical research materials in clinical trials only

You do not need to apply for an import licence and a wholesaler dealer’s licence for CPM.

However, you will need to submit a Clinical Research Material (CRM) Notification to our Innovation Office & Clinical Trials Branch prior to the import and supply of an unlisted CPM for use as CRM in a clinical trial.

Import and wholesale by licensed CPM manufacturers

If you hold a valid manufacturer's licence for CPM, you do not need:

  • An import licence for CPM to import the CPM, required for carrying out the manufacturing activities in accordance with your manufacturer’s licence for CPM. This includes CPM required for further manufacturing or assembly in Singapore, such as repackaging activities.
  • A wholesale dealer’s licence to wholesale the CPM that you have manufactured in accordance with your manufacturer’s licence for CPM.

Manufacturers

Overview

All local facilities engaged in the manufacture or assembly of CPM must have a valid manufacturer’s licence for CPM. Your company must comply with Good Manufacturing Practice standard before the licence is granted to you.

If you hold a valid manufacturer's licence for CPM, you do not need:

  • An import licence for CPM to import the CPM required for carrying out the manufacture in accordance with your manufacturer’s licence for CPM. This includes CPM required for further manufacturing or assembly in Singapore, such as repackaging activities.
  • A wholesale dealer’s licence to wholesale the CPM that you have manufactured in accordance with your manufacturer’s licence for CPM.
Share