Import or wholesale of therapeutic products for clinical use
An importer’s licence for therapeutic products (TPIL) and a wholesaler’s licence for therapeutic products (TPWL) are required to import and wholesale therapeutic products respectively. Your company must comply with the Good Distribution Practice (GDP) standard before these licences are granted to you.
If you are the product registrant and 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.
If your company is involved in both import and wholesale of therapeutic products, you may bundle the applications for both the importer's licence (TPIL) and wholesaler's licence (TPWL), so that a lower bundled application fee can be applied. This is not applicable if your company’s importer’s licence is for restricted activity only.
Import and wholesale of unregistered therapeutic product for patient's use
For the import and wholesale of an unregistered therapeutic product for patient’s use, apart from the TPIL and TPWL, a consignment approval from our Therapeutic Products Branch will also be required prior to the import.