Title f-27 LAWS reference
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CANADA • Title f-27 Laws • Part 21.92
Part 21.92 — Advanced therapeutic product licence
This section details the conditions and process for obtaining or amending an advanced therapeutic product licence. The Minister may issue or amend a licence if the applicant demonstrates that the product's benefits outweigh its risks and that associated risks will be adequately managed. Applications must follow specified procedures and provide required information. The Minister also has the authority to impose or amend terms and conditions on these licences.
What this part covers
- An applicant for an advanced therapeutic product licence must provide sufficient evidence that the benefits associated with the product outweigh the risks.
- An applicant must demonstrate that the risks associated with the advanced therapeutic product and the activity will be adequately managed and controlled.
- Applications for an advanced therapeutic product licence or its amendment must be filed with the Minister in the form and manner specified by the Minister.
- Applications must set out the information required by the Minister as well as any prescribed information.
- The Minister may impose or amend terms and conditions on an advanced therapeutic product licence.
Sections in Part 21.92
Regulatory Context
This document sits within CANADA Laws and is most useful when linked to operational submission, quality, and inspection workflows.
CANADALaws