Border Integrity Approach (POL-0059)

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Contact Information for the Border Integrity Unit

Cover Letter

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.

Supersedes: New document

Date issued: June 1, 2010

Date of implementation: June 1, 2010

Disclaimer

This document does not constitute part of the Food and Drugs Act (Act) or its associated Regulations and in the event of any inconsistency or conflict between that 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. This document is not intended to provide legal advice regarding the interpretation of the Act or Regulations. If a regulated party has questions about their legal obligations or responsibilities under the Act or Regulations, they should seek the advice of legal counsel.

Table of contents

• 1.0 Purpose
• 2.0 Background
• 3.0 Scope
• 4.0 Definitions
• 5.0 Policy Statement
• 6.0 Responsibilities
• 7.0 Border Integrity Activities
  • 7.1 Effective legislative and regulatory framework
  • 7.2 Partnership Development (Domestic and International)
  • 7.3 Public awareness and education
  • 7.4 Information Technology
• 8.0 Associated Documents

1.0 Purpose

This document outlines to the public, staff and stakeholders of the Health Products and Food Branch Inspectorate (Inspectorate) the main elements of the Inspectorate National Border Integrity Program. Through a risk based approach this program aims to effectively and consistently administer the requirements of the Food and Drugs Act (FDA) and its associated Regulations as they apply to the importation and exportation of health products under the mandate of the Inspectorate.

2.0 Background

The mandate of the Health Products and Food Branch (HPFB) is to take an integrated approach to the management of the risks and benefits of health products and food by minimizing health risk factors to Canadians while maximizing the safety provided by the regulatory system for health products and food; promoting conditions that enable Canadians to make healthy choices; and, providing the public with information so that they can make informed decisions about their health.

The Inspectorate is responsible for the delivery of compliance and enforcement activities aimed to protect the integrity of the supply chain through the use of appropriate measures to manage health and safety risks posed to Canadians due to the use of health products. It is estimated that eighty percent of health products available to Canadians are imported¹. Consumers rely on Health Canada to verify that only health products approved for sale are available to them in the Canadian market.

In order to achieve a comprehensive regulatory system, it is necessary for the Inspectorate to not only work in collaboration with other government departments, but also establish strategic partnerships with healthcare professionals, industry, consumers, and stakeholders, both domestic and international, in order to maintain a safe supply of health products within the Canadian marketplace.

The National Border Integrity Program delivered by the Inspectorate addresses the challenges created by an increase in the importation of new health products; the rapid expansion of global trade; and the complexity of the supply chain including consumer direct access to less expensive or socially stigmatized products available through internet marketing. The Inspectorate takes a risk management approach to the delivery of the program and collaborates closely with various partners.

In order to achieve a comprehensive regulatory system, it is necessary for the Inspectorate to work in collaboration with other government departments, and to establish strategic partnerships with health care professionals, industry, consumers, and stakeholders, both domestic and international, in order to maintain a safe supply of health products within the Canadian market. The partnership with the Canada Border Services Agency (CBSA) facilitates the enforcement of the requirements under the FDA with respect to importation and exportation of health products to mitigate the health and safety risks posed to Canadians.

3.0 Scope

This document outlines the Inspectorate’s plan for the delivery of the Border Integrity Program which applies to all health products under the Inspectorate’s mandate including: medical devices; human drugs, natural health products; blood and blood components for transfusion; semen for assisted conception; human cells, tissues, organs for transplantation; and veterinary drugs moving across the Canadian border.

4.0 Definitions

The following terms are defined for the purposes of this document:

Food and Drugs Act: A federal statute regulating the health and safety of food, drugs, cosmetics, and medical devices. The Minister of Health is responsible for the administration of the Act.

Health Products: 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.

5.0 Policy Statement

The Inspectorate, through the National Border Integrity Program and in partnership with CBSA, ensures the consistent administration of the FDA at the border and provides information to Canadians so that they can make informed choices related to the importation and exportation of health products. The program applies a risk-based approach to achieve the greatest impact and efficiency of resources by expediting border processing of compliant health products while systematically assessing the compliance of health products that are suspected to be in violation of the FDA and its associated Regulations.

6.0 Responsibilities

The maintenance and enhancement of health and safety is a responsibility that is shared among government and industry, consumers, healthcare professionals and their respective associations.

It is the Inspectorate’s responsibility to conduct border integrity activities in accordance with the pillars of the Border Integrity Program articulated in this document.

Importers must comply with all Canadian legislative and regulatory requirements and have a responsibility for ensuring the safety of all products that they bring into the Canadian market. Healthcare professionals are encouraged to inform the HPFBI of any problems they encounter (adverse reactions, malfunctions, and non-compliance) that may be related to these health products, including those that have been imported. They should ensure that the health products they provide to their clients and patients are authorized by Health Canada.

Consumers have a responsibility for the maintenance of their health and the safe use of marketed health products. In addition, consumers are asked to inform the HPFBI of any problems that they encounter (adverse reactions, malfunctions, and non-compliance) through the use of health products. Consumers are advised to only import products which are authorized for sale in Canada.

7.0 Border Integrity Activities

The National Border Integrity Program supported by four pillars to ascertain that only health products that are in compliance with the Food and Drugs Act and associated Regulations will enter Canada through importation:

1. Effective legislative and regulatory framework;
2. Strategic domestic and international partnerships;
3. Increased awareness and public education and;
4. Efficient use of information technology.

7.1 Effective legislative and regulatory framework

Under the Food and Drugs Act and its Regulations, the Inspectorate has the authority to inspect and take samples of health products intended for importation into Canada upon their arrival. The Inspectorate also requests CBSA to target and detain specific shipments or products for an admissibility determination by the Inspectorate. If at the border, the Inspectorate concludes that a shipment contains health products intended for distribution in Canada that are not in compliance with the FDA, the Inspectorate will take the appropriate compliance and enforcement actions based on risk that may include the refusal of entry, use of targets and lookouts to prevent future importation of such products, seizure and/or voluntary disposal.

The CBSA assists Health Canada by detaining shipments of health products for their inspection and decision regarding admissibility. Authority for CBSA to detain such shipments is contained in Section 101 of the Customs Act.

7.2 Partnership Development (Domestic and International)

The creation of a National Border Integrity Program is the result of the Inspectorate’s goal to seek innovative solutions and ways to improve our business by learning from “best practices” of other regulatory agencies. Many countries have also placed a high priority on border security and the Inspectorate aims to develop and participate in domestic and international partnerships, to share intelligence data and to establish effective mechanisms that support joint actions.

The Inspectorate continues to collaborate with various federal departments and other regulatory agencies such as CBSA, the US Food and Drug Administration, Royal Canadian Mounted Police and other organizations within the health portfolio to prevent, detect, and deter non-compliant health products from entering the country. This is achieved by developing intelligence capacity related to specific incidents, detection methods, lessons learned, and laboratory techniques both domestically and globally to supply program areas with information to enable strategic monitoring, investigations, and laboratory analysis.

The CBSA and the Inspectorate are committed to establishing service standards that guide the criteria for detecting non-compliant health products at the border, and the timeframes for making admissibility determinations.

7.3 Public awareness and education

Effective border integrity is enhanced with the help of an informed public who can both recognize and understand the risks associated with the importation of non-compliant health products. In the context of the National Border Integrity Program, the Inspectorate delivers health promotion activities to inform the CBSA, the general public and trade-chain partners, including importers, brokers, and freight-forwarders, about the requirements to legally import health products into Canada.

7.4 Information Technology

The Inspectorate recognizes the importance of using emerging technological methods to track, trace and verify compliance of health products at the border and within the supply chain. The Inspectorate is one of approximately forty organizations within eleven government departments, participating in the Single Window initiative led by CBSA. The initiative is aimed at improving the administration of regulatory requirements at the border as they apply to commercial shipments in an electronic commerce world.

The  Single Window Initiative supports the delivery of the Inspectorates Border Integrity Program by using automated risk assessment solution capable of identifying high-risk goods using the Inspectorate criteria that require increased scrutiny while expediting the flow of low-risk goods. For more information on this initiative, refer to the following website.: http://cbsa-asfc.gc.ca/eservices/ogd-amg/menu-eng.html#c01

8.0 Associated Documents

 Customs Act

 Canadian Border Services Agency Act

 Food and Drugs Act

 Food and Drugs Regulations

 Medical Devices Regulations

 Natural Health Products Regulations

 Safety of Human Cells, Tissues and Organs for Transplantation Regulations

 Processing and Distribution of Semen for Assisted Conception Regulations

POL-0001 Compliance and Enforcement

¹Canada’s Proposed Food and Consumer Safety Action Plan 2007