Summary of Key Changes - Compliance and Enforcement Policy (POL-0001) [Health Canada, 2005]

Contact Name: Policy and Strategic Planning Division
Fax: 613-952-9805
Email: Policy and Strategic Planning Division

The updated Compliance and Enforcement Policy, the first update since its inception in 2001, is the foundation document which describes how the Health Products and Food Branch Inspectorate delivers its national compliance and enforcement program. The policy lays out the roles and responsibilities of regulated parties, consumers and health care professionals in ensuring the safe and effective manufacture and use of health care products.

This policy applies to all health products regulated under the Food and Drugs Act, including medical devices, human drugs, natural health products, blood and blood components for transfusion, semen for assisted conception, cell, tissues and organs for transplantation, and veterinary drugs.

The policy was revised to reflect our changing regulatory environment (including new Natural Health Products Regulations) and ensure the policy more directly reflects and emphasizes, the inclusion of all therapeutic health products medical devices; human drugs, natural health products, blood and blood components for transfusion, semen for assisted conception, cell, tissues and organs for transplantation, and veterinary drugs. Food products are not included within this policy as compliance and inspection activities are the responsibility of the  Canadian Food Inspection Agency.

It is our hope that this revised policy will provide regulated parties with a more precise understanding of their responsibilities, the remedies available to them, and the regulatory compliance measures that may be undertaken by the Inspectorate in the event of non-compliance.

In addition to clarification and terminology updates, the policy provides a more complete explanation of what is considered a risk, including the fact that the absence of a valid marketing authorization is considered a risk to health and safety, irrespective of any other factors related to the product or activity in question. The policy clarifies for industry and stakeholders that a valid marketing authorization is a legal document issued by Health Canada, authorizing the sale of a drug or a device based on the health and safety requirements of the Food and Drugs Act and its associated Regulations. The marketing authorization may be in the form of a Drug Identification Number (DIN), a device licence for classes II, III and IV medical devices, or a Natural Health Product Number (NPN) or Drug Identification Number - Homeopathic Medicine (DIN-HM) Number.

The substance of the old POL-0001 document was retained but clarified and updated to more directly reflect the Food and Drugs Act and associated Regulations. This document is reviewed periodically. Comments from the public and stakeholders are welcomed.

Comments on this document may be addressed to the Policy and Strategic Planning Division of the Health Products and Food Branch Inspectorate, by e-mail at Policy and Strategic Planning Division or by fax at 613-952-9805.

The policy is effective as of May 30, 2005.

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