Title f-27 LAWS reference
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CANADA • Title f-27 Laws • Part 21.9
Part 21.9 — Prohibited activities
This section outlines prohibited activities related to advanced therapeutic products, specifying that no person shall import, sell, advertise, manufacture, prepare, preserve, package, label, store, or test such products unless they hold a valid licence, are authorized by an order, or conduct the activity in accordance with regulations. The prohibition applies irrespective of whether the activity is for the purpose of sale or use.
What this part covers
- A person must not import an advanced therapeutic product unless they hold a licence under subsection 21.92(1) authorizing the activity, are authorized by an order under subsection 21.95(1), or conduct the activity in accordance with regulations.
- A person must not sell an advanced therapeutic product unless they hold a licence under subsection 21.92(1) authorizing the activity, are authorized by an order under subsection 21.95(1), or conduct the activity in accordance with regulations.
- A person must not advertise an advanced therapeutic product unless they hold a licence under subsection 21.92(1) authorizing the activity, are authorized by an order under subsection 21.95(1), or conduct the activity in accordance with regulations.
- A person must not manufacture an advanced therapeutic product unless they hold a licence under subsection 21.92(1) authorizing the activity, are authorized by an order under subsection 21.95(1), or conduct the activity in accordance with regulations.
- A person must not prepare an advanced therapeutic product unless they hold a licence under subsection 21.92(1) authorizing the activity, are authorized by an order under subsection 21.95(1), or conduct the activity in accordance with regulations.
- A person must not preserve an advanced therapeutic product unless they hold a licence under subsection 21.92(1) authorizing the activity, are authorized by an order under subsection 21.95(1), or conduct the activity in accordance with regulations.
- A person must not package an advanced therapeutic product unless they hold a licence under subsection 21.92(1) authorizing the activity, are authorized by an order under subsection 21.95(1), or conduct the activity in accordance with regulations.
- A person must not label an advanced therapeutic product unless they hold a licence under subsection 21.92(1) authorizing the activity, are authorized by an order under subsection 21.95(1), or conduct the activity in accordance with regulations.
Sections in Part 21.9
Regulatory Context
This document sits within CANADA Laws and is most useful when linked to operational submission, quality, and inspection workflows.
CANADALaws