Title f-27 LAWS reference
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CANADA • Title f-27 Laws • Part 21.91
Part 21.91 — Additions to Schedule G
This section grants the Minister the authority to add or delete descriptions of therapeutic products or classes of therapeutic products to or from Schedule G. The primary purpose for adding products is to prevent injury to health or deception, particularly for emerging or innovative products. Before adding, the Minister must consider specific factors related to risks, benefits, differences from existing products, and the adequacy of current legal frameworks.
What this part covers
- The Minister shall consider the degree of uncertainty respecting the risks and benefits associated with the therapeutic product or products and the measures that are available to adequately manage and control those risks before adding a description to Schedule G.
- The Minister shall consider the extent to which the therapeutic product or products are different from therapeutic products for which therapeutic product authorizations have been issued under the regulations before adding a description to Schedule G.
- The Minister shall consider the extent to which existing legal frameworks are adequate to prevent injury to health or to prevent persons from being deceived or misled before adding a description to Schedule G.
- The Minister shall consider any prescribed factors before adding a description to Schedule G.
Sections in Part 21.91
Regulatory Context
This document sits within CANADA Laws and is most useful when linked to operational submission, quality, and inspection workflows.
CANADALaws