Incorporation by reference

The Food and Drugs Act (the Act) provides the legal authority for making regulations necessary for administering the Act, as well as the ability to incorporate documents into those regulations using a drafting technique known as incorporation by reference. Several other Acts administered by Health Canada also provide for some form of incorporation by reference, including the:

Incorporation by reference is used to make the content or text of the incorporated document a part of the regulation, regardless of its source and without the need to reproduce the document in the regulation itself. The legal effect of incorporation by reference is to list the incorporated document into the regulations, which are then considered part of the regulations. Documents incorporated by reference therefore have the same force of law as the regulations under which they are incorporated.

Static vs. Ambulatory Incorporation by Reference:

Static Incorporation by Reference:

A static (or closed) reference refers to the incorporation of a document, as it exists at the time it is made part of the regulation. If the document is revised or amended after it is incorporated, the revision or amendment is not incorporated into the regulation and, therefore, the regulation continues to apply in reference to the original document. To incorporate the latest version of the document, the regulation would need to be amended to reference that version of the document through the regular regulatory process.

Ambulatory Incorporation by Reference:

An ambulatory (or open or rolling) reference refers to the incorporation of a document in such a way as to include any future changes to that document without a need to remake the regulation. In the case of this type of incorporation by reference, the regulation incorporating the document would refer to a document "as amended from time to time".

Principles for Modifying Documents Incorporated by Reference:

Modifying Third Party Documents:

The authors of the document manage changes to third party documents that have been incorporated by reference. As such, it is imperative that the process behind the maintenance of third party documents receive close scrutiny prior to the incorporation of these documents.

A number of principles and factors will be taken into careful consideration when determining whether to incorporate by reference a third party document. These include, but are not limited to: the scientific rigour with which the third party document was developed; the relevance of the third party document to the Canadian context; how often the document may be revised; the process by which the document is revised; and the extent of Health Canada's participation and involvement in revisions to the document.

Modifying Health Canada Documents:

Changes to documents incorporated by reference may become necessary, according to new evidence or information received by Health Canada that is relevant to the health and safety of Canadians.

When changes to documents incorporated by reference are considered, a transparent and consultative approach will be used as appropriate, in accordance with best practices for fair, consistent, and transparent regulations. Health Canada will publish a Notice of Proposal for any changes, and aim to provide Canadians with a minimum 60-day consultation period. Before undertaking any changes to the documents incorporated by reference, Health Canada will consider all feedback received during any consultation period.

Documents Incorporated by Reference:

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