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Policy on inspector orders for health products (POL-0139)

  • Date issued: 17 March 2021
  • Date implemented: 17 March 2021
  • Replaces: N/a

Disclaimer

This document does not constitute part of the Food and Drugs Act (the Act) or its regulations and in the event of any inconsistency or conflict between the Act or regulations and this document, the Act or the regulations take precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the regulations and the applicable administrative policies.

Table of contents

Policy on inspector orders for health products POL-0139

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Organization: Health Canada

1. Purpose

The purpose of this policy is to inform stakeholders of the legislative provisions for inspector orders as provided for under the Food and Drugs Act (Act).

This policy explains:

2. Background

This policy is an administrative document. It is intended to help stakeholders comply with the Food and Drugs Act and its regulations, as well as applicable administrative policies. If there is inconsistency or conflict between the Act or regulations and this policy, the Act or regulations take precedence.

The Act and regulations establish a regulatory framework to help protect the health and safety of people who use regulated health products. The regulatory framework also helps to prevent deception in relation to these products.

Under Health Canada's Regulatory Operations and Enforcement Branch (ROEB), two directorates are responsible for the compliance and enforcement of health products:

HPCD and MDCCD staff monitor or verify that health products comply with the Act and its regulations.

The Minister of Health designates inspectors to administer and enforce the Act. They have the authority to enter certain places as described in the Act, as well as the power to issue orders with a view to verify or prevent non-compliance. These orders do not require judicial authorization. The authority to issue an order is provided for regulatory purposes related to reducing health risks associated with health products or activities pertaining to regulated health products.

An order for documents or information gives inspectors a lawful authority to obtain information that may be governed under other statues. These include privacy legislation such as the Privacy Act or the Personal Information Protection and Electronic Documents Act.

3. Responsibilities

Inspectors designated under subsection 22(1) of the Act:

Parties regulated under the Act must:

Under subsection 24(1), a regulated party may not obstruct, hinder or knowingly make false or misleading statements, either orally or in writing, to an inspector.

Parties who are not regulated under the Act may have information concerning a regulated health product or related activity. An inspector may order them to provide information. They will have a duty to comply with the order.

Under these provisions, a person must provide an inspector with any information that an inspector may reasonably require.

Failure to comply with these provisions is an offence.

4. Scope

This policy applies to inspector orders as provided for in the Act. Inspectors designated under ss.22(1) of the Act may issue orders to verify compliance or prevent non-compliance with the Act and its regulations for a range of health products. These include:

5. Policy Statement

Any person whose activities are subject to the Act and its regulations must comply with the legislation. An inspector order is a statutory tool issued by an inspector. It is used to compel the person ordered to take one of the following actions, as laid out in subsections of the Act:

An order to provide information or documents is not limited to information or documents prepared and maintained as a requirement under the Act. Any person can be compelled to produce documents, information, or samples specified and used by the inspector to verify compliance or prevent non-compliance with the Act or its regulations.

The authority for inspectors to issue orders is essential to the effective administration of the Act. It also helps to protect consumers by mitigating risk to their health and safety. Failure to provide all reasonable assistance to an inspector and any individual(s) accompanying them is a serious offence. Health Canada may take action, using measures outlined in the Compliance and enforcement policy for health products (POL-0001).

All records collected through inspector orders are handled in accordance with Health Canada's Policy on collection and retention of records related to health products compliance and enforcement (POL-0140).

6. Inspector Orders

Under the Act, the inspector has certain powers to verify compliance with the Act and regulations, as well as to prevent non-compliance.

6.1 Authority for inspectors to issue orders

An inspector may issue an order in accordance with one of five separate subsections of the Act: 22.1(1), 23(5), 25(b), 25(c) or 27.2(1). An order issued in accordance with subsection 22.1(1) must be for the purpose of verifying compliance or preventing non-compliance with the Act. Each subsection authorizing an inspector order has one or more specific requirements that must be met to issue an order.

Provision of documents, information or samples (subsection 22.1(1))

An inspector may, for a purpose related to verifying compliance or preventing non-compliance with the provisions of this Act or the regulations, order a person to provide any documents, information or samples specified by the inspector. This information may be provided on or before the date and time, and at the place and in the manner specified by the inspector.

Stopping or moving conveyance (subsection 23(5))

For the purpose of entering a conveyance, an inspector may order the owner or person having possession, care or control of the conveyance to stop it or move it.

Storing, moving or disposing of seized articles (subsection 25)

An inspector may order its owner or the person having possession, care or control of a seized article to store it or move it at the expense of the person being ordered. Alternatively, with notice to its owner or the person having possession, care or control of it at the time of its seizure, an inspector may dispose of it at the expense of the person to whom the notice is given, if:

Removal or destruction of non-compliant imported health products (subsection 27.2(1))

A non-compliant imported health product is an imported drug, cosmetic or device that does not meet the requirements of the regulations or was imported in contravention of the Act or the regulations. If an inspector has reasonable grounds to believe a product is non-compliant, the inspector may:

6.2 Issuance of an inspector order

An order is made in accordance with the Compliance and enforcement policy for health products (POL-0001). An order may be used when a specific action is required from the person ordered, as well as a response within a specified timeframe. The inspector will usually sign and issue the order in writing. If an order is issued verbally, in most cases it will be followed by a written order no later than the next business day. Orders under subsection 27.2 will always be in writing.

The following information will be included in the order:

6.3 After the order is issued

The person ordered must comply with the order. An order is valid until the inspector is satisfied it has been fulfilled or has been cancelled. Once satisfied, the inspector will inform the person that it has been fulfilled.

If the order is to provide a sample, the inspector will provide the person with a sample receipt.

Under subsection 27.2, if an order deadline for the removal of an import from Canada, or its destruction if removal is not possible, has passed, the articles are forfeited to Her Majesty in right of Canada. They may be disposed of as the Minister may direct. A request for deadline extension under subsection 27.2(1) can be made by communicating directly with the inspector in writing.

6.4 Amending or cancelling the order

If, after issuing an order, the inspector determines the order is no longer necessary, the inspector may cancel the order. The inspector will notify the recipient in writing that the order is no longer in effect.

If after issuing an order, the inspector determines an amendment is necessary, the inspector will cancel the original order and issue a new order.

6.5 Failure to comply with the order

Failure to comply with an order is a serious offence. It may result in the use of other enforcement tools, outlined in Health Canada's Compliance and enforcement policy for health products (POL-0001).

6.6 Obstructing, providing false information or failing to provide assistance

Obstruction, hindering, knowingly lying, or failing to provide all reasonable assistance to an inspector who is carrying out their duties or functions are offences under the Act and will not be tolerated. Further compliance and enforcement actions that may be taken are outlined in the Compliance and enforcement policy for health products (POL-0001).

The inspection provisions in the Act are designed to protect consumers who are vulnerable to risks posed by health products and their advertising. It is a violation of subsection 24(1) to prevent an inspector from inspecting or to make false or misleading statements, orally or in writing.

Depending on the classification of the health product involved and the election of the prosecutor to proceed summarily or on indictment, a violation may result in prosecution. If convicted, a person could be fined or be imprisoned.

Subsection 23(13) puts a duty on the owner or person in charge and any person found in a place entered by an inspector to provide:

Appendix A – Glossary

Acronyms

HPCD
Health Products Compliance Directorate
MDCCD
Medical Devices and Clinical Compliance Directorate
ROEB
Regulatory Operations and Enforcement Branch

Terms

Appendix B – References

Laws and regulations

Policies

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