Guide to the precision regulating authorities under the Food and Drugs Act: Definitions and interpretations
The following terms used in this guide are defined from the Food and Drugs Act (FDA) or an interpretation is provided.
Activity: An activity may include importing, selling, advertising, manufacturing, preparing, preserving, packaging, labelling, storing or testing a product.
Confidential business information: Section 2 of the FDA sets out 3 conditions that must be met for information to be considered confidential business information:
- "in respect of a person to whose business or affairs the information relates, means (subject to the regulations) business information:
- (a) that is not publicly available
- (b) in respect of which the person has taken measures that are reasonable in the circumstances to ensure that it remains not publicly available and
- (c) that has actual or potential economic value to the person or their competitors because it is not publicly available and its disclosure would result in a material financial loss to the person or a material financial gain to their competitors."
Food: Section 2 of the FDA defines food as "includes any article manufactured, sold or represented for use as food or drink for human beings, chewing gum, and any ingredient that may be mixed with food for any purpose whatever."
Minister: In this guide, Minister refers to the Minister of Health.
Ministerial order: A ministerial order lays out decisions or rules made by the Minister that are authorized by the legislation. To support transparency, orders made by the Minister should clearly communicate the decision or rules and any conditions related to that decision.
Person: Section 2 of the FDA defines a person as "an individual or an organization as defined in section 2 of the Criminal Code." For example, this could include a single person, an individual company, a research institution, a corporation or an authorization holder.
Therapeutic product: Section 2 of the FDA defines a therapeutic product as "a drug or device, or any combination of drugs and devices." Therapeutic products include, for example:
- biocides
- vaccines
- medical devices
- gene and cell therapies
- natural health products
- cells, tissues and organs
- blood and blood components
- prescription and non-prescription human and veterinary drugs
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