Natural and Non-prescription Health Products: Documents Incorporated by Reference into Regulations

Health Canada's incorporation by reference policy

Incorporation by reference is a term used to describe a mechanism which allows a document or list that is not in the text of the regulations to be made a part of the regulations. Health Canada uses incorporation by reference to achieve policy and regulatory objectives.

The Health Canada incorporation by reference policy sets out Health Canada's framework for the identification, development and management of documents incorporated by reference into the regulations that Health Canada administers. Its aim is to ensure the responsible, transparent, and consistent use of incorporation by reference by Health Canada programs, including the Natural and Non-prescription Health Products Directorate (NNHPD).

Incorporation by reference of documents into Regulations

Chapter 4 of the Health Canada incorporation by reference policy describes the legislative authorities that enable the government to incorporate by reference documents into federal regulations. 

With respect to natural health products and non-prescription drugs, sections 30.5 and 30.6 of the Food and Drugs Act provide the explicit authority to the Governor in Council or Minister of Health to incorporate by reference any document into the Natural Health Products Regulations (NHPR) and the Food and Drug Regulations (FDR).

This may include documents generated and managed by Health Canada, other government agencies and departments, or third parties. The incorporation may be 'static', meaning incorporating by reference a specific version of a document as it exists on a particular date, or it may be 'ambulatory', meaning incorporating by reference a document that will be amended from time to time.

How documents incorporated by reference are modified

Documents incorporated by reference into the Regulations may need to be revised from time to time to address new science, an emerging health risk, technical or administrative updates, or feedback from stakeholders, including international partners.

Chapter 8 of the Health Canada incorporation by reference policy establishes the principles and practices that must be followed when modifying documents that have been incorporated by reference into Regulations. The processes and procedures detailed in the sections below align with that policy. 

Modifying Health Canada documents

Ambulatory documents

Modifications to a Health Canada document that has been incorporated by reference into the Regulations on an ambulatory basis (such as the List D: List of Certain Non-prescription Drugs for Distribution as Samples) are managed administratively by the Natural and Non-prescription Health Products Directorate. No regulatory amendments are required as it is understood that ambulatory documents change from time to time.

Notification of proposed changes are provided via a Notice of Proposal and a parallel World Trade Organization (WTO) notification. Final changes are announced via a Notice of Modification accompanied by a WTO notification.

Notices of Proposal

Notices of Proposal are the means by which Health Canada notifies the Canadian public of its intent to amend a departmental document that is incorporated by reference.

Each Notice of Proposal provides a summary and rationale for the proposal and is published online for public consideration. Each notice will specify a comment period during which interested parties may provide their input on the proposal. Comments are to be sent to the contact identified in the Notice of Proposal.

Notices of Modification

Notices of Modification are the means by which Health Canada notifies the Canadian public that it has amended a departmental document that is incorporated by reference.

Once consultations are concluded and it has been determined that the best course of action is to proceed with a change to the document, Health Canada updates the document in both official languages and notifies stakeholders of the changes and where to find the updated document.

Static documents

In the case of a document incorporated by reference on a 'static' basis, (such as the List A: List of Certain Natural Health Products for Distribution as Samples) a regulatory amendment is always required to change the reference found in the regulations. In such cases, Health Canada follows the regulatory amendment process to incorporate the "new" reference.

Documents currently incorporated by reference into Regulations

Below is a list of Health Canada documents that have been incorporated by reference into regulations since 2020 and that are maintained by the Natural and Non-prescription Health Products Directorate.

A complete inventory of all documents incorporated by reference into regulations administered by Health Canada, including those listed above, is available in the Health Canada incorporation by reference inventory. Archived documents are also listed in the Inventory.

List of Notices of Proposal

None at this time

List of Notices of Modifications