Title f-27 LAWS reference
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CANADA • Title f-27 Laws • Part 21.93
Part 21.93 — Suspension and revocation
This section grants the Minister the authority to suspend or revoke an advanced therapeutic product licence, in whole or in part, under specific conditions. These conditions include situations where the product's risks outweigh its benefits, risks are not adequately managed, or prescribed circumstances for suspension or revocation exist. The Minister can also immediately suspend a licence without prior notice if it is deemed necessary to prevent injury to health.
What this part covers
- The Minister may suspend or revoke an advanced therapeutic product licence if the risks associated with the product outweigh the benefits.
- The Minister may suspend or revoke an advanced therapeutic product licence if the risks associated with the product or any authorized activity are not being adequately managed or controlled.
- The Minister may suspend an advanced therapeutic product licence if any prescribed circumstance for suspension exists.
- The Minister may revoke an advanced therapeutic product licence if any prescribed circumstance for revocation exists.
- The Minister may suspend an advanced therapeutic product licence immediately, without prior notice, if it is necessary to prevent injury to health.
Sections in Part 21.93
Regulatory Context
This document sits within CANADA Laws and is most useful when linked to operational submission, quality, and inspection workflows.
CANADALaws