Import or wholesale of CTGTP for clinical use
An importer’s licence for CTGTP (CTGTPIL) and a wholesaler’s licence for CTGTP (CTGTPWL) are required for the import and wholesale of CTGTP, 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. However, 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 CTGTP, you may bundle the applications for both the importer's licence (CTGTPIL) and wholesaler's licence (CTGTPWL). The fee of a bundled application is lower than the application fees of separate licences. However, you cannot apply the bundling of licences if your company’s importer’s licence is for restricted activity only.
Import and wholesale of unregistered CTGTP for patient's use
Companies who import unregistered CTGTP for named patient(s) will require an approval via the Special Access Route (SAR) from our Advanced Therapy Products Branch prior to each import. In addition, a CTGTPWL is also required if the company is importing the unregistered CTGTP on behalf of the healthcare institution where the patient is being treated.