Guidance Document: Classification of Products at the Cosmetic-Drug Interface

The purpose of this guidance document is to provide an understanding of the factors that guide classification decisions by Health Canada in relation to external use products which may share characteristics of both 'cosmetic' and 'drug', as currently defined under the Food and Drugs Act. The criteria identified in this document outline the decision-making process in determining the appropriate regulatory regime that applies to a given product at the cosmetic-drug interface (PCDI), being sensitive to stakeholders' interests but without compromising health and safety standards. This guidance document is in keeping with international practices of documenting approaches to classification decisions.

Note: The industry guideline is not a legally binding act or regulation in Canada. Rather, it serves as an interpretive document that consolidates the requirements outlined in relevant acts and regulations. Nonetheless, it is recommended that enterprises adhere to the guidelines to ensure compliance.

Content

Foreword

1.0 Introduction

• 1.1 Objective

• 1.2 Definitions

• 1.3 Scope and Application

• 1.4 Background
  

2.0 Guiding Principles


3.0 Criteria

• 3.1 Representation

• 3.2 Composition

• 3.3 Level of action

• 3.4 Other considerations
  

4.0 Implementation