Policy on collection and retention of records related to health product compliance and enforcement (POL-0140)
- Date issued: 17 March, 2021
- Date implemented: March 17, 2021
- Replaces: N/A
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
- 1. Purpose
- 2. Background
- 3. Responsibilities
- 4. Scope
- 5. Policy statement
- 6. Procedure
- 6.1 Entering a place for inspection
- 6.2 Records – general principles
- 6.3 Examination, collection and retention of records
- 6.4 Use of computer systems or telecommunication systems (subsection 23(2)(e))
- 6.5 Record transmission
- 6.6 Taking photographs, making recordings and sketches (subsection 23(2)(j))
- 6.7 Certified copies (subsection 36(3) of the Act)
- 6.8 Security and proper handling of sensitive information
- 6.9 Retention of records
- 6.10 Obstructing, providing false information, or failing to provide assistance
- Appendix A – Glossary
- Appendix B – References
The purpose of this policy is to inform stakeholders of the legislative provisions related to records accessed and obtained by inspectors during compliance and enforcement (C&E) activities, as provided for in the Food and Drugs Act (the Act), as well as the Government of Canada's policies in respect of the collection, electronic transfer, retention and disposal of records.
This policy explains:
- the authority of inspectors to acquire, access, copy, reproduce, download, save, transfer/transmit, and retain records acquired or created during C&E activities
- the rights and responsibilities of parties
- the consequences for parties that obstruct, hinder or provide false information, or fail to provide reasonable assistance to an inspector
This policy is an administrative document. 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 the compliance and enforcement of 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 comply 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, and to acquire, access, copy, reproduce, download, save, transfer/transmit, and retain records related to the administration of the Act or its associated regulations.
When an inspector believes, on reasonable grounds, that records include information relevant to the Act or associated regulations, under the authority of the Act, they may:
- take photographs and make recordings or sketches
- examine any article
- test any article
- open and examine any container, receptacle or package
- examine, copy, make copies of or reproduce books, documents, reports, test data, shipping bills, bills of lading, labels, advertising and promotional material, or other records, including electronic data
- print, copy or extract data from any computer system
Over the course of an inspection or compliance verification, inspectors may come across records containing personal information, such as patient prescriptions, adverse event reports, medical records, complaint records, or sales records. Although this information may be found in records that are subject to an inspector's authority to examine or make copies, inspector activities with respect to the collection and use of personal information are subject to the Privacy Act, which governs the collection, use, disclosure and retention of personal information.
Inspectors designated under subsection 22(1) of the Act:
- collect, possess, retain, and archive records of business value, and follow Health Canada's information management policies and applicable legislation
- protect the records in their possession from unauthorized access, disclosure, alterations, and from deterioration and loss
- ensure that records, e-mail and mobile messages that contain information of business value are transferred to an official Health Canada repository as soon as possible
- report to their supervisor or manager if the regulated party obstructs, hinders, provides false or misleading statements or refuses to provide all reasonable assistance
- comply with the Privacy Act, Access to Information Act, and Personal Information Protection and Electronic Documents Act
Parties regulated under the Act must:
- understand their legal obligations
- comply with applicable legislative provisions
- be prepared to be inspected at any reasonable time
- provide all reasonable assistance to the inspector
- includes providing information that establishes their identity to the inspector's satisfaction
- includes providing records, or access to records, which an inspector requires to verify compliance with the Act or associated regulations
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.
These provisions require a person to provide an inspector with any information that an inspector may reasonably require.
Failure to comply with these provisions is an offence.
This policy applies to records created and acquired during inspections, including activities undertaken to verify compliance, either in person, as authorized by subsection 23(1), or remotely, by means of telecommunication as authorized by subsection 23(3) the Act.
Under subsection 22(1), inspectors have the authority to verify compliance or prevent non-compliance with the Act and its regulations for a range of health products, including:
- medical devices
- human drugs (pharmaceuticals, biologicals, radiopharmaceuticals)
- natural health products
- blood and blood components for transfusion or for the use in the manufacture of a drug for human use
- cell, tissues and organs for transplantation
- veterinary drugs and veterinary health products
5. Policy statement
Inspectors acquire records during the course of their C&E duties to verify compliance with regulatory requirements. Compliance actions include activities such as inspections, surveillance, sampling, testing, or responding to complaints; enforcement actions include activities such as seizure, recall, amendment or revocation (suspension or cancellation) of an authorization or a license.
Records created and acquired during C&E activities are the property of the Government of Canada. Records include paper records, electronic records (emails, databases, internet, data), and publications (reports, books, magazines and all other forms including films, sound recordings, photographs, documentary art, graphics and maps). Records fall under two categories: information resources of business value and transitory information resources.
Transitory records are information received by an inspector for information purposes, and are of use for a limited time. Transitory records are disposed of once the information is no longer of use. Information resources of business value must be saved in the official repository. Inspectors are responsible for the custodianship and retention of all records of business value from the point of collection until the documents are saved in the official repository.
The authority for inspectors to examine and copy documents, use computer systems, or take photographs or make sketches is essential to the effective administration of the Act, and therefore the protection of consumers by mitigating risk to the health and safety of the public. This authority is used to help reduce the risk to consumers' health and safety. Failure to provide all reasonable assistance to an inspector is a serious offence. Health Canada may take action, using measures outlined in the Compliance and enforcement policy for health products (POL-0001).
6.1 Entering a place for inspection
Under the Act, the inspector has certain powers to verify compliance with the Act and regulations, as well as to prevent non-compliance.
Power to enter a place (subsection 23(1))
An inspector, and any individual(s) accompanying them under the authority of subsection 23(7) of the Act, may enter any place, including a conveyance, in which they have reasonable grounds to believe that:
- an activity that may be regulated under this Act is being conducted
- any article to which this Act or the regulations apply is located, or
- an activity could be conducted under an authorization, including a licence, for which an application is under consideration by the Minister
Inspectors may enter places that meet the criteria described in subsection 23(1) of the Act at any reasonable time. While the facts will establish 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, unless the place being entered is a dwelling-house.
Power to conduct a remote entry (subsection 23(3))
An inspector can also enter a place as described in Accessing the Premises of a Regulated Party Remotely to Verify Compliance (POL-0138) by means of telecommunication.
Power to enter private property (subsection 23(8))
An inspector and any individual accompanying them under the authority of subsection 23(7) of the Act, may enter and pass through private property, other than a dwelling-house on that property, in order to enter the place to be inspected.
Consent to enter a dwelling-house (subsection 23(9))
When a regulated party conducts business in their home, an inspector and any individual accompanying them under the authority of subsection 23(7) of the Act, may enter the dwelling-house only if the occupant consents or if 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.
6.2 Records – general principles
Integrity of records
Records provide reliable, objective evidence to confirm that the regulated activities were conducted in compliance with the requirements of the Act and regulations. Records can be created manually or can be generated electronically. Irrespective of the method used, data integrity of the records is fundamental in ensuring that the records created are attributable, legible, contemporaneous, original, accurate and complete (ALCOAC).
The use of an electronic record as objective evidence requires proof of the authenticity of the record. Authenticity can be demonstrated by the integrity of the electronic record management system in which the record was made, received, or stored, as well as proof that the record was made in the usual and ordinary course of business. For more details on the proof of the integrity of an organization's record system, refer to the Canadian General Standards Board's guideline, CAN/CGSB-72.34-2017 Electronic Records as Documentary Evidence.
Regulated parties using electronic records as their principal method of data capture should establish a process that includes record protection measures (restricted entry/security, audit trail, backup) and record quality assurance. The record management process should ensure that:
- audit trails of record system changes and alterations are maintained
- electronic records are created, received or stored within a reasonable time after the events to which they relate, or stored within a reasonable time after they are received
- data entry procedures are part of the usual and ordinary course of business of the organization
- data is traceable to its origin
- the use of the data in the organization's electronic records complies with the relevant Canadian privacy statutes governing the collection, use or disclosure of personal information, confidential commercial information, and other sensitive information
- the regulated party complies with applicable electronic records management standards
- the regulated party's software reliably operates the electronic records system and processes its data
- security procedures are in place to protect against unauthorized access, and disaster recovery plans exist to provide a fail-safe for the electronic records system
6.3 Examination, collection and retention of records
Examine and make copies (subsection 23(2)(c))
After an inspector has entered a place under subsection 23(1) of the Act, whether they have entered physically or via remote entry, an inspector may access, review, print, reproduce, and take screenshots, copy and/or export copies of the data to confirm compliance to the Act. Subsection 23(2) of the Act gives an inspector the authority to access, examine, and make copies of any records that are found at the place, and that the inspector believes, on reasonable grounds, include information relevant to the administration of this Act or the regulations. This also includes records generated and maintained in computerized systems, including, but not limited to, electronic communications, e-mails, spreadsheets, and security camera footage that relate to regulated activities. In addition, regulated parties may also voluntarily provide information to inspectors, or these records may be provided through other means, such as orders, or complaints received from the public.
Reproduce electronic data (subsection 23(2)(d))
Any reproduced electronic record shall be generated in a readable/viewable format as requested by the inspector. Whenever paper or electronic copies of electronic records need to be produced, they can be authenticated as certified true copies by the inspector. Where the paper copy differs in structure, form or content from the electronic record, the nature of the difference, and the reason for the differences, will be documented in the paper copy. Whenever possible, regulated parties should supply copies of electronic records in common readable formats, such as, but not limited to, Portable Document Format (PDF), Microsoft Excel (XLS), Microsoft Word (DOC), or Digital Image (JPEG). Copies of the original documents must preserve the content and meaning of the record.
The regulated party must provide all reasonable assistance to the inspector during compliance and enforcement activities. Records requested by an inspector must be made available to the inspector within a reasonable amount of time and should be presented in a manner that permit their full assessment; this also includes retrieval by the regulated party of electronic records from another location or site. These records or copies are subject to photocopying or other means of reproduction as part of the inspection. The regulated party may retain records as either original records or as true copies, such as photocopies, microfilm, microfiche, or other accurate reproduction of the original records. Where a reducing technique such as microfilming is used, suitable reading and photocopying equipment must be readily available for the inspector's use. Electronic copies are considered true copies of paper or electronic records, provided the copies preserve the content and meaning of the original record, which includes metadata.
6.4 Use of computer systems or telecommunication systems (subsection 23(2)(e))
After entry into a place under subsection 23(1) or 23(3) of the Act, an inspector may access a computer system or a telecommunication system available at the facility to confirm compliance or prevent non-compliance with the Act and regulations. Examples of systems/applications that an inspector may require access to include:
- a laboratory information management system (LIMS)
- audit trails to analytical instrumentation, such as High Performance Liquid Chromatography (HPLC) or Liquid Chromatography-mass spectrometry (LC-MS/MS) systems
- electronic case report forms
- electronic databases
- building automation systems (BAS)
- systems such as document management, complaint management or training management
- manufacturing equipment Human Machine Interfaces (HMIs)
Depending on system complexity, an inspector may access the computer on their own, or may ask a person from the regulated party to be present and to assist with the navigation of the system. To facilitate the inspection, the regulated party should consider establishing a formal process for granting and modifying system access to inspectors for the duration of the inspection. The regulated party may establish a role-based access control for their computerized system such that the inspector can have "read only" access to the records required to verify compliance to the Act and regulations. If a role-based access control cannot be established, then the inspector will request that company personnel be present when they access the system.
6.5 Record transmission
Interoperability among technologies used between ROEB and a regulated party is important for transmitting data between both parties during an inspection. Any protected or classified electronic data sent by an inspector to a regulated party should be securely transmitted using Health Canada approved electronic transmission applications, or Health Canada approved portable data storage devices (for example, USB devices, tablets, laptops, smart devices, portable media). The inspector will protect the records in accordance with applicable legislation and follow Health Canada's information management policies and procedures. Electronic records obtained from the regulated party will be transferred to Health Canada's official repository within a reasonable timeframe.
Inspectors will follow the Government of Canada’s information technology policy on the Secure Use of Portable Data Storage Devices within the Government of Canada to minimize risk to protected, classified and confidential information. Inspectors are only permitted to use authorized devices on Health Canada’s network. The use of unauthorized portable data storage devices (for example, non-government issued USB devices, or portable media) presents risks to the Government of Canada’s information technology (IT) network security. Risks include the introduction of malicious software onto Health Canada IT network, unauthorized access or use of the information stored on the device, or loss or theft of the device itself.
6.6 Taking photographs, making recordings and sketches (subsection 23(2)(j))
Inspectors are authorized to take photographs and make recordings (audio and/or visual) and sketches per subsection 23(2)(j) of the Act to verify compliance or to prevent non-compliance with the provisions of this Act or the regulations. Photographs are an integral part of an inspection, and they can present an objective and contemporaneous representation of regulated activities, products and/or facilities. Consent of the company representative is not required for taking a photograph or recording of objective evidence related to enforcement of the Act. Any refusal on the part of the representative of the regulated party could be considered an obstruction to inspection activities. Photographs and recordings are taken using government-issued devices. Inspectors take digital recordings in order to achieve the following:
- accurately depict documents, labels, records, facilities, processes or procedures reviewed during the course of an inspection
- accurately document suspected non-compliance
- support objective evidence for inspection observations
- accurately represent a situation/condition that can more effectively be illustrated by a digital recording than through inspector notes
While taking photographs and recordings, the inspector will avoid capturing any personal and/or private information irrelevant to the administration/enforcement of the Act. All digitized images will be transferred to an official repository within a reasonable time. Inspectors may include sketches of the facility to add to the completeness and comprehension of the inspector notes.
6.7 Certified copies (subsection 36(3) of the Act)
A copy of or extract from a document, including electronic data, can be certified to be a true copy by the inspector who collected the records under subsection 23(2)(c),(d)or (f).
For records submitted by a regulated party as part of a C&E action such as an inspector order, an inspector can request the party to submit a certified true copy, copies certified by affidavits, or originals. Inspectors shall only request originals when necessary to verify compliance or prevent non-compliance.
6.8 Security and proper handling of sensitive information
Records of business value stored in an inspector's portable device(s) are transferred to Health Canada's official repository as soon as possible. Inspectors will secure portable storage devices at all times, as appropriate to the highest level of security classification of the data on the device. Inspectors follow Health Canada Information Management's security requirements when transporting sensitive information between sites or during travel using a secure portable electronic data storage system.
6.9 Retention of records
Records of business value created or collected by inspectors during C&E activities are the property of the Government of Canada. These information resources are subject to various legislative, regulatory and policy requirements governing their retention and disposition. Records are managed in Health Canada's official repository, which facilitates the creation, acquisition, management, use, storage, disclosure, accessibility, confidentiality and destruction of records. Inspection records are saved in individual inspection files that follow standardized classification taxonomy within the corporate repository, ensuring easy access when needed to support program and service delivery. The length of time the C&E records of business value are retained depends on several factors, including, but not limited to the following:
- the type of information resources
- how long the information will be useful to the program area
- how long any regulation, legislation or standard requires the information to be kept and maintained
- the likelihood that the information will be needed in the future for litigation, an access to information request, or a privacy request
Inspection records remain usable, accessible and retrievable for the entire period of their retention times. The contextual and structural integrity of Information Resources of Business Value (IRBV) are also maintained.
Disposal of records
Destruction of C&E records follows the Records Retention and Disposal Schedule (RRDS) established by Library and Archives Canada (LAC). RRDS prescribes requirements for the length of time a government record must be retained and the means of disposal at the end of its lifecycle.
Confidential information and privacy concerns
Items or things (including, but not limited to, premises, records, and equipment) related to the administration of the Act or its associated regulations are subject to inspection. When an inspector believes, on reasonable grounds, that records include relevant information, the inspector, and by extension individuals accompanying them, in accordance with their identified role(s) in the inspection, are authorized to view or examine those things to verify compliance or prevent non-compliance.
Regulated businesses have a reduced expectation of privacy than individuals. When a person undertakes business activities regulated under legislation, those businesses are subject to inspection for compliance with all applicable legislation. However, the inspector and any individual(s) accompanying them will make every reasonable effort to minimize risk to protected, classified and confidential information. Inspectors will communicate the importance of proper handling of sensitive information and ensure that individuals accompanying them on inspection understand this.
6.10 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 can 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:
- reasonable assistance
- required information
Appendix A – Glossary
- Compliance and Enforcement
- Health Products Compliance Directorate
- Information Resources of Business Value
- Medical Devices and Clinical Compliance Directorate
- Regulatory Operations and Enforcement Branch
- Certified copy: A copy (irrespective of the type of media used) of the original record that has been verified (by a dated signature or by generation through a validated process) to have the same information, including data that describe the context, content, and structure, as the original.
- Compliance: The state of conformity of a regulated party (including a corporation, institution, individual or other legal entity) or a product with a legislative or regulatory requirement.
- Compliance verification: Actions taken to verify compliance in response to information regarding known or suspected non-compliance with the applicable requirements of the Act and its regulations. This includes actions such as information gathering via either off-site or on-site visits.
- Consent: Consent given by an individual that is the result of free choice. The statement is obtained without compulsion, solicitation or coercion.
- Corporate repository: Information resources of business value are captured, preserved and managed through the lifecycles. It contains both specified physical or digital storage space and the associated information management infrastructure required for its maintenance.
- Dwelling-house: Defined in the Criminal Code as the whole or any part of a building or structure that is kept or occupied as a permanent or temporary residence. Includes:
- a building within the curtilage of a dwelling-house and that is connected to it by a doorway or a covered and enclosed passageway, and
- a unit that is designed to be mobile and to be used as a permanent or temporary residence and that is being used as such a residence
- Electronic record: An analogue or digital record that is carried by an electrical conductor and requires the use of electronic equipment to be intelligible by a person (Ref: CAN/CGSB72.34-2017).
- Enforcement: Actions that may be taken to compel or induce compliance in order to mitigate the risk identified by non-compliance with the Act and its associated regulations.
- Government record: A record that is under the control of government institution (Library and Archives Canada Act, LACA). This covers a wide array of government documents including e-mails.
- Health product: Includes any product regulated under the Act and falling within the mandate of the MDCCD and HPCD, such as:
- pharmaceutical, biological and radiopharmaceutical drugs for human use
- veterinary drugs
- medical devices
- natural health products
- blood and blood components for transfusion or for use in the manufacture of a drug for human use
- cells, tissues and organs for transplantation
- Information resources of business value: Captures day-to-day business activities and decision-making processes. Information resources include textual records (memos, reports, invoices, contracts, etc.), electronic records (e-mails, databases, web pages, data, etc.), communication media (telephone conversations, instant messages, wikis, blogs, podcasts, etc.), publications (reports, books, magazines), films, sound recordings, photographs, documentary art, graphics, maps, and artefacts.
- Inspection: Monitoring and assessment against the applicable requirements of the Act and its associated regulations. Inspections are routinely conducted based on risk to assess compliance.
- Inspector: Any person designated as an inspector under section 22 of the Act.
- Metadata: Data that describe the attributes of other data, and provide context or meaning. Typically, these are data that describe the structure, data elements, inter-relationships and other characteristics of data. It also permits data to be attributable to an individual.
- Notes: The recording of all information as it relates to a specific compliance or enforcement activity.
- Objective evidence: information that can be proved true, based on facts obtained through observation, measurement, testing or other means.
- Person: Defined in section 2 of the Act to mean an individual or an organization as defined in section 2 of the Criminal Code.
- Reasonable grounds to believe: Beliefs based on compelling and credible information such as knowledge, experience, expert advice or other information from a reliable source. Vague suspicion, subjective opinion or speculations are not sufficient to meet the requirement of having reasonable grounds of belief.
- Record: A type of document that permanently captures information demonstrating that an action was taken. It can be in either hard copy (printed) or electronic (digital) format. The information can take various forms such as text, figures, graphics, data pictures and videos
- Regulated party: Any party regulated under the Food and Drugs Act and its associated regulations because they engage in any regulated activity
- Remote entry: The entry of a place by an inspector by means of telecommunication.
- Telecommunications: Defined in the Interpretation Act as the emission, transmission or reception of signs, signals, writing, images, sounds or intelligence of any nature by any wire, cable, radio, optical or other electromagnetic system, or by any similar technical system.
- Transitory records: Transitory records are not of business value. They may include records that serve solely as convenience copies or records held in government institution repository, but do not include any records that are required to control, support, or document the delivery of programs, to carry out operations, to make decisions, or to provide evidence to account for the activities of the government at any time.
- True copy: A copy (irrespective of the type of media used) of the original record that has been verified (i.e. by a dated signature or
- by generation through a validated process) to have the same information, including data that describe the context, content, and structure, as the original ((MHRA GMP Data Integrity Definitions and Guidance for Industry March 2018).
Appendix B – References
Laws and Regulations
- Access to Information Act
- Canada Evidence Act
- Criminal Code of Canada
- Food and Drugs Act
- Interpretation Act
- Library and Archives of Canada Act
- Personal Information Protection and Electronic Documents Act
- Privacy Act
Other related documents
- Compliance and enforcement policy for health products (POL-0001)
- Assessing the premises of a regulated party remotely to verify compliance (POL-0138)
- Electronic records as documentary evidence
- Secure use of portable data storage devices within the Government of Canada
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