Health Products and Food Branch Inspectorate - Recall Policy (POL-0016)

Unit Name: Drug Compliance Verification and Enforcement Unit
Fax: (613) 952-9805
Email: DCVIU_UVCEM@hc-sc.gc.ca

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Cover Letter

Health Products and Food Branch Inspectorate
Graham Spry Building, 3^rd Floor
250 Lanark Avenue
Address Locator # 2002B
Ottawa, Ontario
K1A 0K9

April 18, 2006

06-107468-94

To: All Interested Parties

I am pleased to inform you that the document entitled "Health Products and Food Branch Inspectorate Recall Policy" (POL-0016) is now available on the Compliance and Enforcement section of Health Canada's website at the following address:

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/drugs-drogues/docs/index-eng.php

This policy states requirements and responsibilities that should be achieved by all parties planning for and carrying out recalls in accordance with the regulatory requirements of the Food and Drugs Act (the Act), Food and Drug Regulations including Division 5 (Drugs for Clinical Trials involving Human Subjects), Medical Devices Regulations, Natural Health Products Regulations, and Processing and Distribution of Semen for Assisted Conception Regulations (the Regulations) regarding the recall of health products in Canada.

This Policy "Health Products and Food Branch Inspectorate Recall Policy", replaces the policy aspect of the current document entitled "Product Recall Procedures" published in December 10, 1993, which contains both policy and guidance elements. Guidance documents are currently being developed to update and augment the Product Recall Procedures.

A draft version of the Health Products and Food Branch Inspectorate policy was posted on the Health Canada web site for a 60 day comment period in February 2005. Comments received from stakeholders and interested parties were reviewed and incorporated.

Inquiries about this document can be addressed to the Drug Compliance Verification and Investigation Unit, Fax: (613) 952 - 9805 or by E-Mail: DCVIU_UVCEM@hc-sc.gc.ca.

Original signed by

Diana Dowthwaite
A / Director General

Cover Page

OUR MANDATE:

To promote good nutrition and informed use of drugs, food, medical devices and natural health products, and to maximize the safety and efficacy of drugs, food, natural health products, medical devices, biologics and related biotechnology products in the Canadian marketplace and health system.

Supercedes:
New document

Date issued:
April 18, 2006

Date of implementation:
May 18, 2006

Ce document est aussi disponible en français.

Table of Contents

• 1.0 Purpose
• 2.0 Background
• 3.0 Scope
• 4.0 Definitions
• 5.0 Policy Statement
• 6.0 Responsibilities
  • 6.1 Responsible Parties
  • 6.2 Inspectorate
  
  
• Appendix 1 Mandatory Actions
• Appendix 2 Health Products and Food Branch Inspectorate - Operational Centres

1.0 Purpose

This policy states what should be achieved by all parties planning for and carrying out recalls in accordance with the regulatory requirements of the Food and Drugs Act (the Act), Food and Drug Regulations including Division 5 (Drugs for Clinical Trials involving Human Subjects), Medical Devices Regulations, Natural Health Products Regulations, and Processing and Distribution of Semen for Assisted Conception Regulations (the Regulations) regarding the recall of health products in Canada.

2.0 Background

A recall is a method for removing or correcting a distributed health product, including its labelling, that violates the Act or the Regulations or that may present a risk to the health of the consumer. Recalls of health products may be undertaken anytime, in response to a formal request by Health Canada through the Health Products and Food Branch Inspectorate (Inspectorate), or on the initiative of responsible parties (see definition in Section 4). This serves to carry out our combined responsibility to ensure compliance with the legislation, and to protect the health of consumers. A responsible party's recall does not preclude other actions which could be taken by the Inspectorate or the responsible party.

Information on certain recalls is shared with other countries in line with agreements negotiated with those countries (see Mutual Recognition Agreement (MRA) and Pharmaceutical Inspection Cooperation Scheme (PIC/S) below).

This policy Health Products and Food Branch Inspectorate Recall Policy, replaces the policy aspect of the current document entitled Product Recall Procedures published in December 10, 1993, which contains both policy and guidance elements. Guidance documents are currently being developed to update and augment the Product Recall Procedures.

The Act and the Regulations are the final authority in all matters of recall.

3.0 Scope

This policy is applicable to all recalls, as defined in this policy, and includes removal from sale or use, or correction of, a distributed health product (see definition of a health product) in Canada, by the responsible party/legal agent. Recalls do not include stock recovery of products which have not left the direct control of the recalling responsible party, product withdrawals which are conducted when there is no health and safety risk or no contravention of the applicable legislation, or the issuing of product communications that reinforce labelling information. This policy also applies to the information dissemination (internally and externally to Health Canada) stipulated in international agreements (e.g., Rapid Alert notifications). This policy does not apply to biological products for veterinary use licensed with the Canadian Food Inspection Agency or to devices for veterinary use.

4.0 Definitions

Many of the terms used throughout this document are defined in the Act or the Regulations, in the Criminal Code or in other Inspectorate compliance and enforcement policies. The following terms are consistent with definitions in other Inspectorate documents.

Blood Establishment: Facility that collects blood and/or manufactures blood components intended for transfusion.

Consignee (for Medical Devices): Means anyone who received, purchased, or used the product being recalled.

Correction (for Medical Devices): Means repair, modification, adjustment, relabelling, or inspection (including patient monitoring) of a product without its physical removal to some other location.

Distributor: A person, including an association or partnership, who under their own name, or under a trade, design or word mark, trade name or other name, word, or mark controlled by them, sells a food or drug. (A.01.010)

Divisions 1A and 2 to 4 apply to the following distributors (C.01A.003):

1. a distributor of a drug listed in Schedule C or D to the Act or in Schedule F to these Regulations, a controlled drug as defined in subsection G.01.001 (1) or a narcotic as defined in the Narcotic Control Regulations who does not hold the drug identification number for the drug or narcotic; and
2. a distributor of a drug for which that distributor holds the drug identification number.

Effectiveness Check: Includes a survey of those affected by the recall (consignees) to verify they have received the recall information and are aware of any appropriate action to be taken and may include verification of the action taken. The recalling responsible party is responsible for conducting effectiveness checks, which may also be undertaken, or verified, by the Inspectorate.

Global Harmonization Task Force: The Global Harmonization Task Force (GHTF) is a voluntary group of representatives from national medical device regulatory authorities and the regulated industry. The purpose of the GHTF is to encourage convergence in regulatory practices related to the safety, effectiveness/performance and quality of medical devices, to promote technological innovation and facilitate international trade. The primary way in which this is accomplished is via the publication and dissemination of harmonized guidance documents on basic regulatory practices. The GHTF also serves as an information exchange forum through which countries with medical device regulatory systems under development can benefit from the experience of those with existing systems and/or pattern their practices upon those of GHTF founding members.

Health Hazard Classification: The numerical designation, i.e., Type I, II or III, assigned by Health Products and Food Branch (HPFB or the Branch) to a particular product to indicate the relative degree of health hazard presented by the product, as follows:

Type I: a situation in which there is a reasonable probability that the use of, or exposure to, a product will cause serious adverse health consequences or death,

Type II: a situation in which the use of, or exposure to, a product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote, or

Type III: a situation in which the use of, or exposure to, a product is not likely to cause any adverse health consequences.

Type I and II include situations where a product ( which does not have generally recognized or scientifically supported therapeutic value ) is promoted in such a way that avoidance of recognized therapy occurs and where such avoidance could lead to injury or death.

Health Hazard Evaluation: A report issued by Health Canada and or the responsible party to assess the hazard posed by a health product and the likelihood or risk of the hazard recurring, based on available information.

Health Product: A health product includes any product under the mandate of the Health Products and Food Branch (HPFB), with the exception of food products. The HPFB has regulatory responsibilities in the following health product areas: drugs for human use; blood and blood products; medical devices; transplanted tissues and organs; biologics and genetic therapies; natural health products; and veterinary drugs.

Legal Agent (for Drugs): A person, including an association or partnership, who under their own name, or under a trade, design or word mark, trade name or other name, word or mark controlled by them, sells a food or drug. For a drug imported into Canada for the purpose of sale, the legal agent is the person responsible for the sale of the drug and whose name and address of the principal place of business in Canada appears on the inner and outer labels of the drug. (Legal Agent is a term used to describe the manufacturer or distributor as defined in A.01.010, and in the case of an imported drug, it is that person referred to in C.01.004.1)

Manufacturer (for Drugs): "manufacturer" or "distributor" means a person, including an association or partnership, who under their own name, or under a trade, design or word mark, trade name or other name, word or mark controlled by them, sells a food or drug. (as defined in A.01.010)

Manufacturer (for Medical Devices): A person who sells a medical device under their own name, or under a trade-mark, design, trade name or other name or mark owned or controlled by the person, and who is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the device, or for assigning to it a purpose, whether those tasks are performed by that person or on their behalf.

Manufacturer (for Natural Health Products): A person who fabricates or processes a Natural Health Product for the purpose of sale, but does not include a pharmacist or other health care practitioner who, at the request of a patient, compounds a natural health product for the purpose of sale to that patient.

Mutual Recognition Agreement: Agreements between Canada and foreign countries or associations of countries to: a) enhance bilateral regulatory cooperation; b) establish mutual recognition for Good Manufacturing Practices (GMP) compliance certification and acceptance of Manufacturing Authorizations/Licences directly issued by authorities designated equivalent after the successful completion of a confidence building exercise; and to c) develop an infrastructure for ongoing communications/consultations between them and Canada to enable regulators to determine and maintain the equivalency of their GMP compliance programmes. For more information, refer to the Compliance and Enforcement section of Health Canada's web site: http://www.hc-sc.gc.ca/dhp-mps/compli-conform/int/index-eng.php.

Pharmaceutical Inspection Cooperation Scheme: The purpose of the PIC/S is to strengthen the cooperation established between the participating authorities in the field of inspection and related areas, to maintain mutual confidence and promote quality assurance of inspections, to provide the framework for all necessary exchange of information and experience, to coordinate mutual training, to improve harmonization of technical standards and procedures regarding the inspection of the manufacture and testing of medicinal products, to continue common efforts for the development, harmonization and maintenance of Good Manufacturing Practices (GMP), and to extend the cooperation to other competent authorities having the national arrangements necessary to apply equivalent standards and procedures with a view to global harmonization.

Plasma Establishment: Facility that collects source plasma for the purpose of further manufacturing.

Processor: A person or establishment who collects, tests, prepares, preserves, labels, and stores semen for use in assisted conception.

Product Withdrawal: A responsible party's removal from further sale or use, or correction of a distributed product where there is no health and safety risk and no contravention of the legislation. It is not considered to be a recall.

Rapid Alert: The Rapid Alert or Two-Way Alert System officially applies to the human/animal medicinal products/drugs covered by the Mutual Recognition Agreement and includes the following situations, that negatively affect or may negatively affect the quality of the named classes of products:

• confirmed problem reports, corrective actions, or recalls;
• the cancellation or suspension of a manufacturing authorization or an establishment licence related to quality deficiencies, in whole or in part, by a regulatory authority listed in the agreement;
• counterfeiting and tampering.

Recall: With respect to a health product, other than a medical device, means a responsible party's removal from further sale or use, or correction, of a distributed product that presents a risk to the health of consumers or violates legislation administered by the Health Products and Food Branch.

Recall: As defined in the Medical Devices Regulations "recall", in respect of a medical device that has been sold, means any action taken by the manufacturer, importer or distributor of the device to recall or correct the device, or to notify its owners and users of its defectiveness or potential defectiveness, after becoming aware that the device: a) may be hazardous to health; b) may fail to conform to any claim made by the manufacturer or importer relating to its effectiveness, benefits, performance characteristics or safety; or c) may not meet the requirements of the Act or the Regulations.

Responsible Party: The responsible parties for the purpose of recall are the legal agents/manufacturers/distributors for drugs, the manufacturers and importers for medical devices, the manufacturers, importers, distributors, or product licence holders for natural health products, the processors for semen, blood establishments for blood or blood components or plasma establishments in the case of plasma for further manufacturing, and the sponsors of clinical trials.

Risk Benefit Assessment: A report that weighs the potential risks or hazards associated with a product against the benefits of that product to a specific individual or population. It is used to determine whether or not the overall benefits of treating the individual or population with that product outweigh the risks.

Source Plasma: Means human plasma collected by plasmapheresis that is intended for use in producing a drug for human use.

Sponsor: Division 5 of the Food and Drug Regulations defines sponsor as "an individual, corporate body, institution or organization that conducts a clinical trial."

Stock Recovery: A responsible party's removal or correction of a product that has not been distributed or that has not left the direct control of the responsible party. It is not considered to be a recall.

Wholesale: To sell any of the following drugs, other than at retail sale, where the seller's name does not appear on the label of the drugs:

1. a drug listed in Schedule C or D to the Act or in Schedule F to these Regulations or a controlled drug as defined in subsection G.01.001 (1); or
2. a narcotic as defined in the Narcotic Control Regulations. (as defined in C.01A.001)

5.0 Policy Statement

It is the policy of the Inspectorate to verify that recalls of health products in Canada are conducted, and reported, in accordance with the Act and the Regulations. The Inspectorate expects the responsible parties to take full responsibility for product recalls. Further compliance actions in accordance with the Inspectorate's Compliance and Enforcement Policy, POL-0001, may be taken if a responsible party/legal agent fails to voluntarily recall a health product. The legislation does require mandatory actions as outlined in Appendix 1.

The objectives of the Inspectorate as they relate to recall are to verify that:

1. noncompliant or potentially harmful health products are removed from distribution in accordance with the principles of risk management, and that measures are taken to correct the deficiencies in an effective and timely manner;
2. our voluntary and mandatory commitments to International partners are fulfilled, including the distribution of Rapid Alert notifications on recalled drug products;
3. manufacturers, importers, sponsors of clinical trial drugs and distributors establish and implement documented procedures that will enable them to carry out effective and timely investigation of reported problems and recalls and that wholesalers implement documented procedures for recalls;
4. the Inspectorate is informed when recalls are initiated as per the Act and the Regulations, and is provided with information about the results of recalls and the actions taken to prevent recurrence of problems; and
5. manufacturers, importers, sponsors and distributors maintain records of:
   • incidents
   • complaints
   • adverse reactions
   • and of actions taken in response to these reports or incidents.

6.0 Responsibilities

6.1 Responsible Parties

The Inspectorate expects the responsible parties to take full responsibility for product recalls and conduct effectiveness checks, but these effectiveness checks may also be undertaken, or verified, by the Inspectorate.

Reporting to Health Canada:

Under the Regulations, responsible parties must notify the Inspectorate when recalls are initiated, and under this policy they are expected to make progress reports to the Inspectorate when requested, and to undertake recalls when requested to do so by Health Canada. Responsible parties must notify the Inspectorate at the Operational Centre responsible for their province as outlined in Appendix 2. Alternatively, you can call the Inspectorate's toll free number at: 1-800-267-9675.

The Regulations and this policy require a documented recall system which can be implemented to ensure that the Inspectorate is notified of the recall.

• The Food and Drug Regulations state "forthwith" for drugs and the Medical Devices Regulations state "on or before undertaking a recall" for medical devices. This shall be interpreted to mean:
  • For drugs, a manufacturer or importer who is recalling a drug is required to submit to the closest Operational Centre of the Health Products and Food Branch Inspectorate the information specified in section C.01.051. This notice should be provided to the Inspectorate within 24 hours of having made the decision to recall. The initial notification may be made verbally or in writing. This must be followed by a written report within 3 business days of initiating the action containing sufficient information to enable Health Canada to assess the risk to health.
  • For medical devices, the time frame for reporting described as "on or before" is satisfied by submitting as much of the recall detail as is known within 24 hours of having made the decision to recall. The initial notification may be made verbally or in writing. This must be followed by a written report containing full information as required by Section 64 within 3 business days of initiating the action.
• For Natural Health Products, Section 25 of the Natural Health Products Regulations requires that every licensee who commences a recall of a natural health product shall provide to the closest Operational Centre of the Health Products and Food Branch Inspectorate the information referred to in section 62, within 3 days after the day on which the recall is commenced.
• For blood or blood components, the establishment must report errors/accidents, post donation information, adverse transfusion reactions, lookback/traceback and serious donor events as stated within the Whole Blood and its Components Annex to Establishment Licences, which is affixed to Establishment Licences issued to all Blood Establishments.
• For semen investigations, as stated in section 15 of the Processing and Distribution of Semen for Assisted Conception Regulations, every processor shall provide notice within 3 days of commencing an investigation and shall provide an update every 30 days on the progress of an investigation until the final report is provided.

Record keeping and standard operating procedures:

The Regulations require manufacturers and importers/distributors to maintain necessary records and to develop a system of control for product recalls that can be put into effect when needed.

• For clinical trial drugs, the sponsor should maintain a system for retrieving clinical trial drugs and documenting this retrieval of deficient product.
• Action taken to recall a product that is suspected or known to be defective is prompt and in accordance with a predetermined plan. The procedures to be followed are in writing and known to all responsible staff.
• Person or persons responsible for initiating and coordinating all recall activities are identified.
• The procedure can be put into operation at any time, during and outside normal working hours.
• Recall procedures put into place by the responsible party outline the means by which the responsible parties notify Health Canada, product distributors and users, conduct a recall and any follow-up activities.
• Distribution records enable tracing of products and accounting for all products including those in transit, on loan, samples removed by the quality control department and any professional samples distributed.
• Recalled products are identified and placed in quarantine until disposition is determined.
• Progress and efficacy of the recall are assessed and recorded at intervals and a final report issued including a final reconciliation of implicated products.
• Foreign manufacturers or commercial customers in countries outside of Canada that have imported the product are notified.

6.2 Inspectorate

The Inspectorate's responsibility under this policy is to enforce the Act and Regulations, to monitor company recalls and assess the effectiveness of a responsible party's action. The Inspectorate assesses the causes of the problem and reviews the product disposition. The Inspectorate ensures that an appropriate Health Hazard Classification (Type I, II, III) or Risk Benefit Assessment (RBA), as appropriate, is assigned to the risk posed by the product. This may involve a request for a formal Health Hazard Evaluation (HHE) or a RBA. Although the responsible party recalling the product may issue a press release, HPFB may issue its own communiqué about a recall when it believes the public needs to be alerted about a serious hazard. The responsible party may be advised of this communiqué and when possible a draft may be shared.

The Inspectorate's responsibilities under the drug MRA's are stipulated in those agreements, and include an alert notification of recalls as appropriate to the level of risk of the product recalled.

There also exist several voluntary agreements for International exchange of information on recalls. These include:

• For Medical Devices, the Global Harmonization Task Force (GHTF) has agreed to a "National Competent Authority Report exchange (NCAR)" which includes information on high risk recalls.
• Courtesy copies to individual countries as appropriate for Type I and II health hazard classifications (e.g. PIC/S and US-FDA).

Where no such agreements are in place, the Inspectorate will make efforts to inform the foreign authority of the status of any exported products posing a serious health hazard.

Appendix 1 Mandatory Actions

Drugs, Blood and Blood Components

Responsible Party	Applicable Regulatory Sections;	Requirements
Packagers/Labellers	C.04.075	Recall of Bacille Calmette-Guerin (BCG) vaccine by packagers/labellers under certain circumstances.
Manufacturers, Importers, Blood establishments	C.01.051	Notification of recall to Health Canada.
Fabricators, Packagers/Labellers, Distributors (referred to in section C.01A.003), Importers, Wholesalers, Blood establishments	C.02.012(1)(a)	Maintenance of a product control system to enable the recall of a drug.
Wholesalers, Distributors (referred to in section C.01A.003), Importers, Blood establishments	C.02.022	Records of all sales are retained or kept readily accessible, for a period of at least one year after the expiration date of that lot or batch, in a manner that will permit a complete and rapid recall of any lot or batch of a drug. This requirement need not necessarily involve tracking by lot number.

Medical Devices

Responsible Party	Applicable Regulatory Sections	Requirements
Manufacturers and Importers	Part 1 sections 52, 57, 58, and 63 to 65, and under Part 3 section 88, of the Medical Devices Regulations.	Complaint handling, implementation of investigation and recall procedures, notification of a recall to Health Canada, and report of completion of a recall and corrective action taken.
Distributors	Part 1 sections 52, 57, 58, of the Medical Devices Regulations.	Complaint handling, implementation of investigation and recall procedures.

Donor Semen

Responsible Party	Applicable Regulatory Sections	Requirements
Processors	Section 15 and 18 of the Processing and Distribution of Semen for Assisted Conception Regulations.	Notify Health Canada.

Natural Health Products

Responsible Party	Applicable Regulatory Sections	Requirements
Manufacturers, Importers and Distributors (product licence holders)	Sections 25 , 50, 53, 56, 57 and 62 of the Natural Health Products Regulations.	Shall establish and maintain a system of control and record keeping to permit a recall. Section 62 outlines the information which must be reported within 3 days of the recall being commenced. Section 25 requires product licence holders to report.
Packagers/Labellers	Sections 50, 54, 55	Shall establish and maintain a system of control and record keeping to permit a recall.

Clinical Trial Drugs

Responsible Party	Applicable Regulatory Sections	Requirements
Sponsors	C.05.010(j)	Procedure for retrieving clinical trial drugs, including comparators, when used. Documenting this retrieval should be established by the sponsor, in collaboration with the manufacturer or importer where different. The qualified investigators need to understand their obligations under the retrieval procedure.

Appendix 2 Health Products and Food Branch Inspectorate - Operational Centres

Atlantic Operational Centre
16^th floor, suite 1625
1505 Barrington Street
Halifax, Nova Scotia
B3J 3Y6
Tel: (902) 426-2160
Fax: (902) 426-6676
E-mail: insp_aoc-coa@hc-sc.gc.ca

Quebec Operational Centre
1001 St-Laurent Street West
Longueuil, Québec
J4K 1C7
Tel: (450) 646-1353
Fax: (450) 928-4455
E-mail: QOC-COQ@hc-sc.gc.ca

Ontario and Nunavut Operational Centre
2301 Midland Avenue
Scarborough, Ontario
M1P 4R7
Tel: (416) 973-1600
Fax: (416) 973-1954
E-mail: insp_onoc-coon@hc-sc.gc.ca

Manitoba and Saskatchewan Operational Centre
510 Lagimodière Blvd
Winnipeg, Manitoba
R2J 3Y1
Tel: (204) 984-1341
Fax: (204) 984-2155
E-mail: Insp_MSOC_COMS@hc-sc.gc.ca

Western Operational Centre
4^th Floor
4595 Canada Way
Burnaby, British-Colombia
V5G 1J9
Tel: (604) 666-3704
Fax: (604) 666-3149
E-mail: insp_woc-coo@hc-sc.gc.ca