Return to table 1 footnote 3 referrer Table 1 footnote X Regulatory Section applies to the API activity Return to the first table 1 footnote X referrer Table 1 footnote Where applicable depending on the nature of the activities. Amples C.02.025 X C.02.026 X Stability C.02.027.02.028 he point at which production of the API begins and from which compliance to GMPs should be implemented should be based on the application filed with Health Canada, where applicable, and/or other criteria including the below Table 2. This guide does not apply to the following: Although BPI are defined as active ingredients in subsection C.01A.001(1) of Division 1A in the Food and Drug Regulations, the present guide does not apply to BPIs.
Agents and brokers of APIs will be considered to be wholesalers if they sell APIs as per the definition of "sell" in the Food and Drugs Act. Whether an agent or a broker is acting as a wholesaler within the meaning of the regulatory scheme may require further review/examination.
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