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Guidance: Drug, natural health product and biocide recall guide (GUI-0039)

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Roles and responsibilities

Establishments in the distribution chain

Recall actions require collaboration, as they could potentially involve all parties in the distribution chain. This chain begins with the manufacturer and proceeds sequentially through importers, distributors, wholesalers, retailers and consumers. The effectiveness of the recall process depends, in part, on the extent to which each party:

Everyone in the distribution chain is responsible for:

Quality agreements with other parties in the supply chain, including wholesalers, distributors or storage sites, should clearly define the responsibilities for each party in the recall strategy.

Maintaining systems that support recall effectiveness

As well, anyone conducting activities for drugs, natural health products or biocides must have in place a system of control that permits the complete and rapid recall of any lot or batch of a product. These activities are outlined in this section.

You should be able to initiate your recall procedures at any time, during or outside normal working hours.

For drugs, this requirement is stated in section C.02.012 of the Food and Drug Regulations (FDR). It applies to:

For natural health products, this requirement is stated in section 50 of the Natural Health Products Regulations (NHPR). It applies to:

For biocides, this requirement is stated in section 48 of the Biocides Regulations (BR). It applies to any person that has sold a biocide.

To learn more about maintaining systems of control that support effective recalls, and to read the exact regulatory text for these requirements, consult:

The responsible party

The responsible party takes the lead on initiating and overseeing a recall. Their responsibilities during a recall include:

The responsible party for a drug recall could be the product’s:

The responsible party for a natural health product recall could be the product’s:

The responsible party for a biocide recall could be the product’s:

The responsible party for a drug, natural health product or biocide may use a third party to carry out the requirements related to a product’s recall. The responsible party must confirm the role of the third party to Health Canada in writing at the time of the recall notification. The responsible party remains accountable for the recall and is still the point of contact with Health Canada.

Distributors and storage sites for natural health products must follow good manufacturing practices, as defined in the NHPR. However, they are not required to hold a site licence. Under the regulations, distributors are responsible for ensuring an effective recall system at the retail level.

If you are the responsible party during a recall, you may be subject to compliance and enforcement actions if you fail to:

Compliance and enforcement actions that may apply are in accordance with the act, the regulations and the Compliance and enforcement policy for health products (POL-0001).

Notifying Health Canada about the recall action

Responsible parties are expected to notify Health Canada at the time a risk to health, that may lead to the recall of a distributed health product, is identified. This is a requirement as outlined in section C.01A.013 of the FDR and stated in the Recall policy for health products (POL-0016).

Responsible parties must notify Health Canada after deciding to recall a drug, natural health product or biocide. This is stated in section C.01.051 of the FDR, section 25 of the NHPR and section 49 of the BR, respectively.

Use the following form to submit this notification, along with the required information:

For more specific guidance on how to notify us about a recall, refer to the Recall notification section in this guide.

Consignees

Consignees who receive a recall notice should:

Health Canada

Health Canada verifies that recalls initiated by the responsible party are conducted effectively and reported according to the regulations.

Recalling drugs, natural health products and biocides

This section tells you how to complete all stages of a drug, natural health product or biocide recall. Unless stated otherwise, the guidance that follows is for the responsible party initiating the recall.

When a product has a potential health risk or contravenes the legislation, you may need to initiate a recall for the product.

Health risk assessment

Before deciding to conduct a recall:

Use the results of your health risk assessment to assign a health risk classification (Type I, II or III) for the recall, as follows:

Recall notification to Health Canada

You must notify us:

Use the following form to submit all required information:

The form includes the:

For drug and biocide recalls, follow up your initial recall notification with a report on your recall strategy. Include the measures you intend to take to prevent a recurrence of the issue that led to the recall within 72 hours of the decision to recall.

If you are in the process of obtaining further information, forward it to us as soon as it becomes available.

For a list of all information you are required to submit related to reporting requirements for a recall, refer to the following sections on this page:

Health Canada also requests that you provide, where applicable:

You should identify any vulnerable populations that may be impacted by the recall (such as infants, children, pregnant people, patients who have just had surgery, patients whose immune systems are compromised). Indicate the recall’s impact on available treatment for the indicated medical condition.

You should advise us of any potential disruption to product supply. Where applicable (refer to the following box), you must take appropriate steps to advise people in Canada of drug shortages by reporting drug shortages and discontinuations on Drug Shortages Canada.

Learn about your specific responsibilities for reporting drug shortages:

For drug product recalls only: Advise us if you believe the product you are recalling is medically necessary. Consider the questions outlined in Appendix A to determine if your drug meets this definition. Use the template in the Template for determination of medical necessity of a drug product (FRM-0378) to provide this information.

Shortage is a situation in which an authorization holder for a drug is unable to meet the demand for the drug.

Drug (for mandatory drug shortage reporting) means any of the following drugs for human use in respect of which a drug identification number was assigned:

  • drugs included in Schedule I, II, III, IV or V to the Controlled Drugs and Substances Act
  • prescription drugs
  • drugs that are listed in Schedule C or D to the act and
  • drugs that are permitted to be sold without a prescription but are to be administered only under the supervision of a practitioner

Recall strategy

Along with the product information outlined in the Recall notification to Health Canada section of this guide, you should provide us with a recall strategy in these timelines:

A recall strategy is a planned course of action taken by a responsible party in conducting a recall. It should include the following components:

Key factors to consider when determining an appropriate recall strategy are the product’s:

You should also take into account:

Health Canada expects that your strategy will name the specific distribution chain levels involved in all recall actions, including pharmaceutical samples distributed by sales representatives. If the recall does not extend to the lowest distribution level (such as retail, hospitals, clinics, pharmacies), a written rationale for this decision should be included.

For complex distribution chains that involve several consignees (for example, wholesalers, cross licensees, distributors), the responsibilities for each party should be clearly defined in a quality agreement and outlined in the recall strategy. For example, you should:

If, as the responsible party, you sell your products directly to the end user, such as through online sales, your recall strategy should include how you will contact end users. You should take a risk-based approach, which may require contacting each consignee directly or issuing a public communication about the recall.

Health Canada may independently evaluate the health and safety risk of the potentially harmful or non-compliant product to verify your health risk assessment. We sometimes recommend that establishments change a recall strategy as a result of a higher-rated risk. To avoid significantly delaying the process, we can recommend changes to a recall strategy while the recall is in progress.

Parts of a recall strategy

Recall strategies address:

Timelines

Clearly set out timelines for finishing each part of the recall. Base your timelines on the following:

Recall communications

Your recall strategy defines the method and content for all communications associated with the recall.

You must provide a copy of your recall communications to Health Canada before you start the recall. We will assess whether your communications are sufficient to mitigate the identified risk to health presented by the product. We expect you to notify consignees in English and French within the timelines set out in the Communication timelines section of this guide.

If you communicate with consignees before receiving our input to avoid delaying the recall process, you should re-send the communication. It’s especially important to do so if we have recommended important changes while the recall is in progress.

Ensure the format, content and extent of your communication is appropriate for the product’s level of risk and for your recall strategy. Recall communications should be brief and to the point. Do not include promotional material or anything that may detract from your message.

Contents of recall communications

Find a sample template for drug recall communications in Appendix B.

In general, recall communications specify:

Also be sure to indicate:

For returns of controlled drugs or substances, provide an authorization to the consignee to comply with the FDR Part G requirements for the sale of controlled substances.

To encourage a quick response from consignees, your recall communications might include:

Recall communication process

Recall communications to consignees can be accomplished in several ways, including by:

You may contact all potential consignees, such as all pharmacies in Canada, to confirm they have received the product. If you choose this communication method, you must have acceptable procedures in place to ensure adequate follow-up and effectiveness checks.

Follow these guidelines to issue a recall communication:

Note: Sending an email is acceptable only if you receive a written response, such as by email or fax, from the consignee. A read receipt is not an appropriate response.

Make follow-up contact by telephone with anyone who fails to respond to the initial recall communication. Do not assume that a confirmation of fax delivery means the correct person received the notice.

If your establishment has a website, posting the recall communication online is an additional method of recall notification only. You should not use this method as your only way of notifying consignees.

Communication timelines

Your recall strategy should specify prescribed timeframes to initiate contact with affected clients. The recall start date occurs when your recall communication is first sent to your consignees. Follow these guidelines:

Reasonable follow-up efforts

Include an expected response time for consignees in your recall strategy. This should reflect your own timeline for initial communication and method of follow-up (for example, mail or courier).

If consignees do not respond to the initial notification, you must follow up. “Non-responders” are people from whom you do not receive a return fax, email, courier or phone message. We expect your recall procedures to define how you will followup with non-responders. At minimum:

Public risk communications

A risk communication alerts the public that the recalled product presents a serious risk to health. Risk communications are appropriate for urgent situations (Type I and occasionally Type II recalls), such as when a widely distributed consumer product is recalled.

We may also recommend that you issue a risk communication based on:

In cases where Health Canada believes the public must be alerted to a serious risk, we may issue our own press release or advisory. For consistent messaging, provide us with your risk communication as soon as possible. If we find your communication inappropriate, inadequate or untimely, we will inform the public on our own.

Your recall strategy should specify the type of risk communication you will use. It could be, for example, a:

For additional Health Canada guidance on public communications, consult:

Effectiveness checks

Health Canada expects you to use information collected from consignees’ responses (as well as the number of non-responders) to periodically create recall effectiveness reports. Effectiveness checks verify whether consignees have received the recall notification and taken appropriate action. If it appears that your recall has been ineffective to date, you will need to develop corrective actions to manage it more effectively.

You should establish criteria for how to figure out your recall’s effectiveness based on these checks. Relate your criteria to the recall’s health risk classification (Type I, II or III). Regardless of the risk, we expect you to have evidence that all consignees have been contacted. This is an important measure of a successful recall.

Initial preliminary reports on effectiveness checks (number of consignees who confirmed they received the recall notification) should be available for reporting to Health Canada, upon request, as follows:

Specific records you may use to periodically check a recall’s effectiveness include:

Progress reports to Health Canada

You should provide progress reports to Health Canada during the recall and include the reporting interval in your recall strategy. The reporting interval is agreed upon with Health Canada and is normally 2 to 4 weeks, depending on the urgency of the recall.

Recall progress reports usually specify the number of:

These reports also specify the:

Progress reports may also include information on:

Recall closure: Final report

When your recall is complete, you should provide a final report with a detailed plan for identifying the root cause of the problem that led to the recall.

Your report should specify, as appropriate:

Food and Drug Regulations requirements for recalls

The following sections set out the provisions in Part C, Divisions 1 and 2 of the Food and Drug Regulations (FDR). We provide a rationale for the regulation (why it’s important) and our interpretation (what you need to do to be compliant), where needed. Each regulation relates to drug product recalls.

For complete guidance on the good manufacturing practices requirements found in Part C, Division 2 of the FDR, consult:

This guidance applies to the following types of drugs:

Reporting

Part C, Division 1, section C.01.051

  1. If a manufacturer who sells a drug in dosage form or an active ingredient or a person who imports into and sells a drug in dosage form or an active ingredient in Canada decides to recall any of those drugs without being ordered to do so by the Minister, the manufacturer or importer shall, within 24 hours after making the decision, provide the Minister with the following information in writing:
    1. the drug’s proper name or the common name, if there is no proper name;
    2. an indication as to whether the drug is a drug in dosage form or an active ingredient;
    3. in the case of a drug in dosage form,
      1. the brand name,
      2. the drug identification number assigned under subsection C.01.014.2(1),
      3. the dosage form,
      4. the strength,
      5. the names of the persons in Canada, other than consumers that purchased the drug at the retail level, to whom the drug was sold by the manufacturer or importer and the quantity sold to each of the named persons, and
      6. an assessment of the effect that the recall may have on the manufacturer’s or importer’s ability to meet demand for the drug in Canada;
    4. the lot numbers of the drug;
    5. the dates of fabrication of the drug;
    6. the expiration dates of the drug;
    7. the quantity of the drug that was fabricated in Canada;
    8. the quantity of the drug that was imported;
    9. the quantity of the drug that the manufacturer or importer sold to persons in Canada and the period during which it was sold;
    10. the quantity of the drug that the manufacturer or importer exported, as well as the quantity exported, by country;
    11. the quantity of the drug in Canada that is in the possession or control of the manufacturer or importer;
    12. an assessment of the risk of injury to human health posed by the drug, including because of a failure of its effectiveness;
    13. the names and civic addresses of the manufacturer and fabricator of the drug and of any importers of the drug;
    14. the name and contact information of the individual who is responsible for the recall;
    15. the expected dates for the start and completion of the recall; and
    16. the reasons for the recall and the date on which and manner in which the situation that prompted the recall was discovered.
  2. The manufacturer or importer shall:
    1. before starting the recall, provide the Minister with a copy of any communications that the manufacturer or importer intends to use in connection with the start of the recall; and
    2. after starting the recall, provide the Minister, on request and within the time specified by the Minister, with a copy of any additional communications that the manufacturer or importer uses, or intends to use, in connection with the recall.
  3. The manufacturer or importer shall, within 72 hours after making the decision to recall the drug, provide the Minister with the following information in writing:
    1. the strategy for conducting the recall, including the time and manner in which the Minister will be informed of the progress of the recall; and
    2. a description of the measures that are intended to be taken to prevent a recurrence of the situation that prompted the recall.
  4. The manufacturer or importer shall, within 30 days after completing the recall, provide the Minister with the following information in writing:
    1. the results of the recall; and
    2. a description of the measures that have been or will be taken to prevent a recurrence of the situation that prompted the recall.
  5. In this section and in section C.01.051.1, active ingredient and fabricate have the same meaning as in subsection C.01A.001(1).
Rationale

Responsible parties must inform Health Canada when they decide to recall a drug product from sale or further distribution.

Interpretation

The responsible party for a drug product recall must provide:

Part C, Division 1, section C.01.051.1

  1. A person who is ordered by the Minister under section 21.3 of the Act to recall a drug in dosage form, or an active ingredient, shall provide the Minister with the following information in the time and manner specified by the Minister:
    1. the quantity of the drug that has been sold by the person at the retail level to consumers in Canada;
    2. if the person has sold the drug to persons in Canada other than consumers referred to in paragraph (a),
      1. the names of those persons and the quantity that has been sold to each of them, and
      2. the period during which the drug was sold to those persons;
    3. the quantity of the drug that the person has exported from Canada, as well as the quantity exported by country;
    4. the quantity of the drug in Canada that is in the possession or control of the person;
    5. the name, title and contact information of an individual from whom the Minister may obtain additional information concerning the recall;
    6. the strategy for conducting the recall;
    7. any other information that the Minister has reasonable grounds to believe is necessary to mitigate the risk of injury to human health; and
    8. if the person is in a position to prevent a recurrence of the situation that prompted the recall, a description of the measures that they intend to take to prevent a recurrence.
  2. The person shall notify the Minister without delay of any change to the information referred to in paragraph (1)(e).
  3. The person shall:
    1. before starting the recall, provide the Minister with a copy of any communications that the person intends to use in connection with the start of the recall; and
    2. after starting the recall, provide the Minister with, on request and within the time specified by the Minister, a copy of any additional communications that the person uses, or intends to use, in connection with the recall.
  4. The person shall notify the Minister in writing, within 24 hours, of the start and completion of the recall.
  5. The person shall, within 30 days after completing the recall, provide the Minister with the following information in writing:
    1. the results of the recall; and
    2. if the person is in a position to prevent a recurrence of the situation that prompted the recall, a description of the measures that they have taken or will take to prevent a recurrence.
Interpretation

The person ordered to recall a drug product must:

If you’re the person who provides information about the recall changes, you must notify us of those changes.

For ordered recalls, you must notify us in writing within 24 hours of the start and completion of the recall. This provides assurance that the ordered recall was initiated and concluded. 

The reporting of the recall completion is similar to voluntary recalls. Requirements may be outlined in the order.

The distinction to be noted here depends on the person ordered to recall. In some cases, the ordered person may not be able to speak to the cause of the risk associated with the drug or is not in a position to prevent a recurrence. If the order was issued to the market authorization holder (or their agent), it is expected that this reporting requirement would be met.

Manufacturing control

Part C, Division 2, section C.02.012 (1)

  1. Every fabricator, packager/labeller, distributor referred to in section C.01A.003, importer and wholesaler of a drug shall maintain
    1. a system of control that permits complete and rapid recall of any lot or batch of the drug that is on the market
Rationale

Recalls remove from the market any drugs that represent a health risk to consumers in Canada. Drugs are also recalled when the act and its regulations have been contravened.

Drugs that have left the premises of their fabricator, packager/labeller, distributor, wholesaler or importer may be found in a variety of locations. Depending on how severe the risk is to public health, products may need to be recalled at 1 or more levels of distribution. Proper systems of control ensure that recalled drug products can be quickly located and removed from further sale or use.

Interpretation

If you fabricate, package/label, distribute, wholesale or import drugs in Canada, you must have written systems in place that allow you to recall a drug product that’s available to consumers. Your standard operating procedure for recalls should specify the following:

These procedures must be reviewed regularly and kept up-to-date. You should document your reasons for any revisions that are made and your system of control should ensure that only current recall procedures are followed.

Your written recall system, including the standard operating procedure described in this guide, must facilitate a rapid and effective recall. It should include the following details:

The recall’s completion date should consider the effectiveness of the recall, how recovered products are disposed of and the corrective action plan.

Specific details of factors identified in the recall system or standard operating procedure may be provided in the recall strategy.

For more information about document control requirements and methods, consult:

Additional guidance

Good manufacturing practices (GMP) guidelines recommend that written records of drug product manufacturing activities are kept by:

If there’s a complaint or suspected defect, the distributor or importer may need to access a contract fabricator’s records to check product quality. To ensure contract fabricators comply with the regulations, their recall procedures should specify that any relevant records be made accessible to the distributor or importer. There must be a record that traces the recalled product from the distributor, importer or licensed wholesaler to the retail store.

Lot numbers do not generally need to be traced per patient.

Patients should be notified of Type I recalls by public advisory or communication to health care providers if the product is only used in a health care setting. A press release from Health Canada or the responsible party may also be helpful. The responsible party is to let pharmacies know if they are expected to contact all patients.

Records

Part C, Division 2, sections C.02.021 to C.02.023

C.02.021:

  1. All records and evidence of the fabrication, packaging/labelling, finished product testing referred to in section C.02.018 and storage of a drug in dosage form that are required to be maintained under this Division shall be retained for 1 year after the expiration date of the drug unless the person’s establishment licence specifies some other period.
  2. Subject to subsection (4), all records and evidence of the fabrication, packaging/labelling, finished product testing referred to in section C.02.018 and storage of an active ingredient that are required to be maintained under this Division shall be retained in respect of each lot or batch of the active ingredient for the following period unless the person holds an establishment licence that specifies some other period:
    1. in the case of an active ingredient that has a retest date, three years after the lot or batch has been completely distributed or
    2. in any other case, one year after the expiration date of the lot or batch.
  3. Subject to subsection (4), all records and evidence of the raw material testing referred to in section C.02.009 and of the testing of packaging/labelling materials that are required to be maintained under this Division shall be retained for five years after the raw materials and packaging/labelling materials were last used in the fabrication or packaging/labelling of a drug unless the person’s establishment licence specifies some other period.
  4. If a fabricator is required to maintain records and evidence in respect of the same active ingredient under subsections (2) and (3), they shall maintain them for the longest period that is applicable.

C.02.022:

  1. Every wholesaler, distributor referred to in section C.01A.003 and importer of a drug in dosage form shall retain records of sale of each lot or batch of the drug, which enable them to recall the lot or batch from the market, for one year after the expiration date of that lot or batch unless their establishment licence specifies some other period.
  2. Every distributor of an active ingredient referred to in paragraph C.01A.003(a) and every wholesaler and importer of an active ingredient shall retain records of sale of each lot or batch of the active ingredient, which enable them to recall the lot or batch from the market, for the following period unless the person holds an establishment licence that specifies some other period:
    1. in the case of an active ingredient that has a retest date, 3 years after the lot or batch has been completely distributed or
    2. in any other case, one year after the expiration date of the lot or batch

C.02.023:

  1. On receipt of a complaint or any information respecting the quality of a drug or its deficiencies or hazards, every fabricator, packager/labeller, wholesaler, distributor referred to in section C.01A.003 and importer of the drug shall make a record of the complaint or information that contains the following:
    1. the results of any investigation carried out under subsection C.02.015(2) and, if applicable, the corrective action taken; or
    2. the name and business address of the person in charge of the quality control department to whom the complaint or information was forwarded under subsection C.02.015(2.1) and the date on which it was forwarded.
  2. Records referred to in subsection (1) shall be retained for the following period unless the person holds an establishment licence that specifies some other period:
    1. in the case of a drug in dosage form, one year after the expiration date of the lot or batch of the drug; and
    2. in the case of an active ingredient,
      1. if the active ingredient has a retest date, three years after the lot or batch has been completely distributed or
      2. in any other case, one year after the expiration date of the lot or batch of the active ingredient
Rationale

Good documentation is an essential part of the quality assurance system and should therefore be related to all aspects of GMP. Good documentation:

Evidence that drugs have been fabricated and packaged/labelled under prescribed conditions can be maintained only after an adequate record system is in place. The information and evidence should provide assurance that imported drugs are fabricated and packaged/labelled in a like manner to those produced in Canada.

Interpretation

The process of completing a drug recall includes enquiring into possible causes of the problem and taking corrective action. Records kept to fulfil the requirements of C.02.021 may provide part of the evidence used in this enquiry.

How to maintain and use records

To use the records required by sections C.02.021 to C.02.023 when planning or conducting the recall of a drug product, you:

For more information on electronic records, consult:

If you fabricate, package/label, distribute, wholesale or import drugs in Canada, you must maintain distribution records for all sales of drugs, including professional samples.

You must keep the following records and ensure they can be readily accessible:

Reviewing information about drug product complaints

Your quality control department is responsible for reviewing all complaints and other information concerning potential deficiencies or risks with products. These reviews must be done according to the following written procedures:

Determining a drug’s level of risk

Before initiating a recall, use the records required as per C.02.023 to conduct a health risk assessment for the drug product. Gather, correlate and evaluate these records to assess the nature and extent of the identified health risk.

Consider the following factors when determining the degree of health risk posed by the product:

Support your conclusion about the product’s risk to health as completely as possible using scientific documents. To fulfill section C.01.051 (1)(p) of the FDR (“reasons for the recall”), you must report your conclusion to Health Canada as part of the initial notification.

Natural Health Products Regulations requirements for recalls

The following sections set out the provisions in Parts 1 and 3 of the Natural Health Products Regulations (NHPR). We provide a rationale for the rule (why it’s important) and our interpretation of it (what you need to do to be compliant), where needed. Each regulation relates to natural health product recalls.

For detailed guidelines about Part 3 of the NHPR, consult:

Records

Part 1, section 23

  1. Every licensee who sells a natural health product shall maintain the following records:
    1. a list of all ingredients contained in each lot or batch of the natural health product that has been made available for sale; and
    2. records containing sufficient information to enable the recall of every lot or batch of the natural health product that has been made available for sale.
  2. The records shall be maintained by the licensee for a period of one year following the expiry date of the natural health product to which that record relates.
Rationale

Good documentation is a key part of a quality system and promotes compliance with GMP requirements. Documentation may exist in a variety of forms, including paper-based, electronic or photographic media.

The various types of documents and media used should be fully defined in the quality system. The documentation system's main objective is to establish, control, monitor and record all activities that directly or indirectly impact all aspects of the quality of natural health products. This includes information from all stages of the product lifecycle.

Records must be reliable, complete, consistent and accurate.

Interpretation

The licence holder of a natural health product is responsible for:

Complying with section 23 will help you provide the information that is referred to in section 62 and required by section 25.

Recall reporting

Part 1, section 25

Every licensee who commences a recall of a natural health product shall provide the Minister with the information referred to in section 62 within three days after the day on which the recall is commenced.

Part 3, section 62

Section 62:

Every manufacturer, importer or distributor who commences a recall of a natural health product shall, within three days after the day on which the recall is commenced, provide the Minister with the following information in respect of the natural health product:

  1. the proper name and the common name of each medicinal ingredient that it contains;
  2. each brand name under which it is sold;
  3. its product number;
  4. the number of each lot or batch recalled;
  5. the name and address of the manufacturer, importer or distributor who commenced the recall;
  6. the reasons for commencing the recall;
  7. the name and address of each person to whom the recalled product was sold by the manufacturer, importer or distributor who commenced the recall;
  8. the quantity of the recalled product that was sold by the manufacturer, importer or distributor who commenced the recall;
  9. the quantity of the recalled product remaining in the possession of the manufacturer, importer or distributor who commenced the recall;
  10. if the recall was commenced by a manufacturer, the quantity of the recalled product that they manufactured;
  11. if the recall was commenced by an importer, the quantity of the recalled product that they imported and the name and address of each person that sold it to them;
  12. if the recall was commenced by a distributor, the quantity of the recalled product that was sold to them and the name and address of each person that sold it to them; and
  13. a description of any other action, in respect of the recall, that the manufacturer, importer or distributor who commenced the recall is taking.
Rationale

Responsible parties must inform Health Canada when they begin a recall of a natural health product from sale or further distribution.

Interpretation

The licence holder, manufacturer, importer or distributor who begins a recall of a natural health product must:

Operations

Part 3, section 50

Every manufacturer, packager, labeller, importer and distributor shall establish and maintain a system of control that permits the rapid and complete recall of every lot or batch of the natural health product that has been made available for sale.

Rationale

Recalls remove from the market natural health products that represent a health risk to Canadian consumers. These products may also be recalled when the act and its regulations have been contravened.

Natural health products that have left the premises of a manufacturer, packager, labeller, distributor or importer are found in a variety of locations. Depending on how severe the health risk is, it may be necessary to recall a product. Manufacturers, packagers, labellers, distributors and importers are expected to be able to recall products from all consumers if necessary.

Interpretation

Written procedures should define controls that ensure a product can be effectively recalled. This includes being able to notify Health Canada.

Your system of control should:

Quality assurance

Part 3, section 51

  1. Every manufacturer, packager, labeller, importer and distributor shall
    1. have a quality assurance person who
      1. is responsible for assuring the quality of the natural health product before it is made available for sale, and
      2. has training, experience and technical knowledge relating to the activity conducted and the requirements of this Part; and
    2. investigate and record every complaint received in respect of the quality of the natural health product and, if necessary, take corrective action.
Rationale

Before initiating a recall, you must gather, correlate and evaluate records to assess the nature and extent of the identified health risk. Use the records required as per section 51(1)(b) as part of the documents you evaluate, to help you determine the possible health risk.

Interpretation

To ensure your records support this requirement, you must:

Records

Part 3, section 53

Manufacturers

Every manufacturer who sells a natural health product shall maintain the following records at the site at which the natural health product is manufactured:

  1. the master production document for the natural health product;
  2. a list of all ingredients contained in each lot or batch of the natural health product;
  3. records of any testing conducted in respect of a lot or batch of raw material used in the manufacture of the natural health product;
  4. records of any testing conducted in respect of a lot or batch of the natural health product;
  5. a copy of the specifications for each natural health product that is being manufactured at the site;
  6. records demonstrating that each lot or batch of the natural health product was manufactured in accordance with the requirements of this Part;
  7. a record of each determination made by the manufacturer in accordance with section 52 and the information that supports that determination;
  8. records containing sufficient information to enable the recall of every lot or batch of the natural health product that has been made available for sale;
  9. a list of all natural health products that are being manufactured at the site; and
  10. a copy of the sanitation program in use at the site.

Part 3, section 54

Packagers

Every packager who sells a natural health product shall maintain the following records at the site at which the natural health product is packaged:

  1. records of any testing conducted by or for the packager in respect of the material used to package the natural health product;
  2. records demonstrating that each lot or batch of the natural health product was packaged in accordance with the requirements of this Part;
  3. records containing sufficient information to enable the recall of every lot or batch of the natural health product that has been made available for sale;
  4. a list of all natural health products that are being packaged at the site; and
  5. a copy of the sanitation program in use at the site.

Part 3, section 55

Labellers

Every labeller who sells a natural health product shall maintain the following records at the site at which the natural health product is labelled:

  1. records demonstrating that each lot or batch of the natural health product was labelled in accordance with the requirements of this Part;
  2. records containing sufficient information to enable the recall of every lot or batch of the natural health product that has been made available for sale;
  3. a list of all natural health products that are being labelled at the site; and
  4. a copy of the sanitation program in use at the site.

Part 3, section 56

Importers

Every importer who sells a natural health product shall maintain the following records:

  1. the master production document for the natural health product;
  2. a list of all ingredients contained in each lot or batch of the natural health product;
  3. records of any testing conducted by or for the importer in respect of a lot or batch of the natural health product;
  4. a copy of the specifications for the natural health product;
  5. a record of each determination made by the importer in accordance with section 52 and the information that supports that determination;
  6. records containing sufficient information to enable the recall of every lot or batch of the natural health product that has been made available for sale; and
  7. a copy of the sanitation program in use by the importer.

Part 3, section 57

Distributors

Every distributor shall maintain the following records at the site at which the natural health product is stored:

  1. records containing sufficient information to enable the recall of every lot or batch of the natural health product that has been made available for sale;
  2. a list of all natural health products that are being stored at the site; and
  3. a copy of the sanitation program in use at the site.

Part 3, section 58

Record maintenance

Every person required under this Part to maintain a record that relates to a lot or batch of a natural health product shall maintain that record for a period of 1 year following the expiry date of the natural health product to which that record relates.

Rationale

Good documentation is an essential part of your quality assurance system and is essential to all aspects of GMP. Good documentation:

Evidence that natural health products have been fabricated and packaged/labelled under prescribed conditions can be maintained only after you have developed adequate record systems. Your records (information and evidence) should provide assurance that any natural health products that you import are fabricated and packaged/labelled in a like manner to those produced in Canada.

Interpretation

Conducting a natural health product recall includes investigating possible causes of the problem and taking corrective action. The records kept to fulfil the requirements of sections 53 to 57 may provide part of the evidence for this investigation.

After Health Canada has been notified about the recall, the inspector assigned to monitoring the recall may ask for a copy of the distribution records for the recalled product. These distribution records must be made available, as per sections 53 to 57. You must also keep all manufacturing, testing and distribution records for at least 1 year after the lot expiry date, as per section 58.

For more information about record-keeping requirements, consult:

Biocides Regulations requirements for recalls

The following sections set out the provisions of the Biocides Regulations (BR). We also provide a rationale for the rule (why it’s important) and an interpretation (what you need to do to be compliant), where needed. Each regulation relates to biocides recalls.

Recalls

Section 48

Recall system

  1. Any person that has sold a biocide must maintain a system of control, including records, that permits the complete and rapid recall of the biocide from the persons to whom they have sold it, other than consumers that purchased the biocide at the retail level.

Retention period

  1. The person must retain each record
    1. in the case where an expiry date is shown on the label of the biocide to which the record relates, for a period that ends no earlier than the last day of the month that is shown as the expiry date; and
    2. in any other case, for at least six years after the day on which the person sold the biocide to which the record relates.

Rationale

Anyone who sells a biocide must maintain a system of control, including records, so that the biocide can be recalled quickly from anyone other than consumers who bought the biocide. This is set out in subsection 48(1) of the BR. 

Interpretation

A retail sale to a consumer means a sale to an end user for personal use (for example, the sale of a household biocide by a retail store to an individual). Sellers of biocides to businesses or institutions (such as organizations, hospitals or schools) should consider these groups in their recall strategy so the removal of a biocide from these groups can take place as needed.

Those who only sell to consumers at retail should respond to any recall notification received from:

Responding to recall notifications may include removing the biocide from further sale and following the recall instructions.

Written procedures

Your system of control should establish written procedures to make it easy to recall a biocide.

These recall procedures should be reviewed regularly and kept up-to-date, and any revisions to those procedures should be documented. An adequate system of control should include measures that permit only current recall procedures to be used.

Conducting an annual recall simulation, based on the system of control, is a useful approach to proactively identify any gaps in the recall system. Annual simulations should be documented to support future audit or compliance action.

The written procedures in your system of control should:

Records

The system of control must include records. In accordance with subsection 48(2), records must be kept until the last day of the month in which the shelf life of the biocide expires, for biocides that show the expiry date on the label. For all other cases, the records must be kept for at least 6 years after the day on which the person sold the biocide.

Records should document the following:

Voluntary recall

Section 49

  1. If any of the following persons decides to recall a biocide that is the subject of a market authorization without being ordered to do so by the Minister, the person must, within 24 hours after making the decision, provide the Minister with the information set out in subsection (2), in writing:
    1. the holder of the market authorization;
    2. an importer of the biocide; or
    3. a person that manufactures the biocide and sells it.

Information to be provided

  1. The information to be provided is as follows:
    1. the biocide’s brand names;
    2. the biocide’s identification number;
    3. the names and contact information of the persons that manufactured the biocide, excluding individuals who are employees or agents of such persons, and, in the case of a recall by the holder, the names and contact information of any importers
    4. the name and contact information of the individual who is responsible for the recall;
    5. the lot numbers, dates of manufacture and expiry dates of the biocide that is being recalled;
    6. the quantity of the biocide that was manufactured in Canada;
    7. the quantity of the biocide that was imported;
    8. the quantity of the biocide that the person sold to persons in Canada;
    9. the period during which the person sold the biocide in Canada;
    10. the quantity of the biocide that the person exported from Canada, as well as the quantity exported, by country;
    11. the quantity of the biocide that is in Canada and that remains in the possession or control of the person;
    12. the names of the persons in Canada, other than consumers that purchased the biocide at the retail level, to whom the biocide was sold by the person and the quantity sold to each of the named persons;
    13. the classes of persons from whom the biocide is being recalled;
    14. the expected dates for the start and completion of the recall;
    15. the reason for the recall and the date on which, and the manner in which, the situation that prompted the recall was discovered;
    16. an assessment of the risk of injury to human health posed by the biocide that is being recalled, including because of a failure of its effectiveness; and
    17. a description of any other measures that the person is taking in respect of the recall.

Communications

  1. The person must
    1. before starting the recall, provide the Minister with a copy of the communications that they intend to use in connection with starting the recall; and
    2. after starting the recall, provide the Minister, on request and within the time specified by the Minister, with a copy of any additional communications that they use, or intend to use, in connection with the recall.

Information requirements — 72 hours:

  1. The person must, within 72 hours after making the decision to recall the biocide, provide the Minister with the following information in writing:
    1. the strategy for conducting the recall, including the time and manner in which the Minister will be informed of the progress of the recall; and
    2. a description of the measures that are intended to be taken to prevent a recurrence of the situation that prompted the recall.

Information requirements — after recall:

  1. The person must, within 30 days after completing the recall, provide the Minister with the following information in writing:
    1. the results of the recall and
    2. a description of the measures that have been or will be taken to prevent a recurrence of the situation that prompted the recall
Rationale

Responsible parties must inform Health Canada when they decide to recall a biocide from sale or further distribution.

Interpretation

The responsible party for a biocide product recall must provide:

Classes of persons refers to particular groups that sell or purchase biocides, such as distributors, hospitals, schools, restaurants or agricultural establishments. Your recall strategy should consider these classes of persons, and the risk associated with the use of the recalled biocide in their environment.

Recall ordered by Minister

Section 50

  1. A person that is ordered by the Minister to recall a biocide under section 21.3 of the Act must provide the Minister with the following information in the time and manner specified by the Minister:
    1. the name, title and contact information of an individual from whom the Minister may obtain additional information concerning the recall;
    2. if known, the names and contact information of the persons that manufactured the biocide that is being recalled, excluding individuals who are employees or agents of such persons, and the names and contact information of any importers;
    3. the total quantity of the biocide that has been sold by the person at the retail level to consumers in Canada;
    4. if the person has sold the biocide to persons in Canada other than consumers referred to in paragraph (c).
      1. the names of each of those persons and the quantity of the biocide that has been sold to each of them; and
      2. the period during which the biocide was sold to those persons;
    5. the quantity of the biocide that the person has exported from Canada, as well as the quantity exported, by country;
    6. the quantity of the biocide that is in Canada and that remains in the possession or control of the person;
    7. the strategy for conducting the recall;
    8. any other information that the Minister has reasonable grounds to believe is necessary to mitigate the risk of injury to human health; and
    9. if the person is in a position to prevent a recurrence of the situation that prompted the recall, a description of the measures that they intend to take to prevent a recurrence.

Change to information — representative

  1. The person must notify the Minister without delay of any change to the information referred to in paragraph (1)(a).

Communications

  1. The person must
    1. before starting the recall, provide the Minister with a copy of the communications that they intend to use in connection with starting the recall; and
    2. after starting the recall, provide the Minister, on request and within the time specified by the Minister, with a copy of any additional communications that they use, or intend to use, in connection with the recall.

Notification of start and completion notification

  1. The person must notify the Minister in writing, within 24 hours, of the start and completion of the recall.

Information requirements — after recall

  1. The person must, within 30 days after completing the recall, provide the Minister with the following information in writing:
    1. the results of the recall; and
    2. if the person is in a position to prevent a recurrence of the situation that prompted the recall, a description of the measures that they have taken or will take to prevent a recurrence.
Interpretation

The person ordered to recall a drug product must:

Notify Health Canada of those changes if you’re the person who provides information about the recall changes.

For ordered recalls, you must notify Health Canada in writing within 24 hours of when the recall was started and completed. This assures us that the ordered recall was initiated and concluded. 

The reporting of the recall completion is similar to voluntary recalls. Requirements may be outlined in the order.

The distinction here depends on the person ordered to conduct the recall. In some cases, the ordered person cannot speak to the cause of the risk associated with the biocide or is not in a position to prevent the cause from occurring again.

If the order was issued to the market authorization holder, or any their agents, this reporting requirement must still be met.

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2024-12-13