Policy on accessing the premises of a regulated party remotely to verify compliance

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.

Date issued: March 1, 2021
Date implemented: March 1, 2021

Table of Contents

Policy on accessing the premises of a regulated party remotely to verify compliance POL-0138

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1.0 Purpose

The purpose of this policy is to inform stakeholders of the legislative provisions for accessing a regulated party's place remotely. Entering a place remotely (using telecommunication) is known as "remote entry."

This policy explains:

2.0 Background

This policy is an administrative document. It is intended to help stakeholders comply with the Food and Drugs Act (the 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 consumers using health products regulated under the Act. It also helps to prevent deception in relation to these products.

Health Canada's Regulatory Operations and Enforcement Branch (ROEB) has two directorates that are responsible for compliance and enforcement activities related to health products. These are the Health Product Compliance Directorate (HPCD) and the Medical Devices and Clinical Compliance Directorate (MDCCD). HPCD and MDCCD staff monitor or verify that health products are in compliance with the Act and its regulations.

Inspectors are designated by the Minister of Health to administer and enforce the Act. They have the authority to enter certain places. This includes the power to access a premise remotely to verify compliance or prevent non-compliance. Not every telecommunication contact by an inspector is considered an entry under subsection 23(3) of the Act. Inspectors and other departmental staff may contact a person without conducting a remote entry. However, when an inspector, for the purpose of subsection 23(1), remotely accesses a place that is not accessible to the public, they will ensure the owner or person in charge has been informed. This follows subsection 23(4).

Examples of telecommunication contact that are not a remote entry are when an inspector:

3.0 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.

Failure to comply with these provisions is an offence.

4.0 Scope

This policy applies to inspections, including activities undertaken to verify compliance, such as accessing a place remotely. Remote entries using telecommunication are authorized by subsection 23(3) of the Act.

Designated inspectors have the authority to verify compliance or prevent non-compliance with the Act and its regulations for a range of health products, including:

Remote entries may only be conducted with the knowledge of the owner or person in charge of the place. Other types of telecommunication contact by inspectors or other staff at Health Canada are not considered an entry under this authority.

5.0 Policy statement

Any person whose activities are subject to the Act and its regulations must comply with the legislation. Inspectors assess compliance using several methods, such as entering a place remotely using telecommunication where appropriate. Telecommunication systems may include telephone, video calling or other web-based systems that fall within the definition of telecommunications as defined in the Interpretation Act.

Once the inspector has informed the owner or person in charge of the remote entry, all inspector authorities provided for in subsection 23(2) of the Act are available to the inspector.

The authority to enter certain places using telecommunications is essential for the protection of consumers. It is used to help reduce the risk to their health and safety. Failure to provide all reasonable assistance to an inspector conducting a remote entry is a serious offence. Health Canada may take action, using measures outlined in the Compliance and enforcement policy for health products (POL-0001).

6.0 Remote entry

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

Power to enter a place (subsection 23(1))

An inspector may enter any place, including a conveyance, in which they have reasonable grounds to believe that:

Inspectors may enter places that meet the criteria described in subsection 23(1) of the Act at any reasonable time. While the facts may dictate what is reasonable, in most cases, the normal working hours of the place being entered is considered reasonable. Consent to enter is not required for entry into a place located in Canada, unless the place being entered is a dwelling-house.

Power to conduct a remote entry (subsection 23(3))

An inspector is considered to have entered a place when they access it remotely by a means of telecommunication.

For example, inspectors may verify that seized or quarantined products are in place by viewing the products through a video link. They may examine:

Requirement for knowledge and limit duration (subsection 23(4))

There are restrictions to an inspector's power to access a place remotely that is not open to the public.

Inspectors may only do so:

Consent to enter a dwelling-house (subsection 23(9))

When a regulated party conducts business in their home, an inspector may enter the dwelling-house only if the occupant consents or there is a warrant (subsection 23(10)).

The inspector must have reasonable grounds to believe that one of the paragraphs in subsection 23(1) applies.

The inspector will use a form to obtain consent from the occupant in advance of the inspection. This form includes details of the inspector's authorities once the inspector enters the dwelling-house.

This consent is separate from the knowledge requirement that is required by subsection 23(4) of the Act.

Other powers (subsection 23(2))

Inspectors may exercise other powers to verify compliance or prevent non-compliance once they have entered a place physically or remotely. Under the authority of the Act, they may:

Decision to conduct a remote entry

The decision to conduct a remote entry follows our Compliance and enforcement policy for health products (POL-0001).

In making the decision to conduct a remote entry, the inspector will consider a number of factors, including:

Inspectors will use their discretion to determine whether an inspection will include both a remote entry and an on-site visit.

Knowledge of a remote entry

An inspector will ensure that the owner or person in charge of the place knows that a remote entry is taking place.

When using conferencing applications, such as web, video or teleconferencing, an inspector will provide written notice in advance. This notice will include:

When inspectors conduct a remote entry by telephone, the owner or person in charge may be informed verbally. In some cases, they may find out at the beginning of the phone call.

Once entered

When the inspector enters a place, they will:

Duration of the remote entry

The duration of the remote entry will be only as long as necessary for the inspector to prevent non-compliance or to verify compliance. The duration will depend on a variety of factors, including how many regulated activities are being inspected and how many health products are impacted. Regulated parties that cooperate can help to shorten the length of time for the remote entry review.

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 (even remotely) 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

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