Draft Guidance Document - <title>

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Contact: Policy Bureau Enquiries

Template Date August 2007

This guidance document is being distributed for comment purposes only.

Published by authority of the Minister of Health

Draft Date: yyyy/mm/dd

Health Products and Food Branch

© Minister of Public Works and Government Services Canada 200? Insert current year

Également disponible en français sous le titre :

Foreword

Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent and effective.

Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. Alternate approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, in order to allow the Department to adequately assess the safety, efficacy or quality of a therapeutic product. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable guidance documents.

Table of Contents

• 1. Introduction
  • 1.1. Policy Objectives
  • 1.2. Policy Statements
  • 1.3. Scope and Application
  • 1.4. Background
• 2. Guidance for Implementation
  • 2.1. Roles and Responsibilities (if applicable)
• Appendices

1. Introduction

...

1.1. Policy Objectives

...

1.2. Policy Statements

...

1.3. Scope and Application

...

1.4. Background

...

2. Guidance for Implementation

...

2.1. Roles and Responsibilities (if applicable)

...

Appendices

...