Disclosure of confidential business information

Related acts and regulations

From Health Canada

This guidance document describes how we disclose confidential business information (CBI) under paragraph 21.1(3)(c) of the Food and Drugs Act.

On this page:

Overview

The Minister of Health is authorized to disclose CBI to eligible people to protect or promote public health or safety.

This guidance document does not apply to other authorities in the Food and Drugs Act, which permit us to disclose CBI:

  • to a government
  • to an advisor to the Minister
  • when the Minister believes a product may pose a serious risk of injury to human health or safety

Health Canada published a draft version of this guidance document on March 10, 2016 for public consultation. The draft version was discussed in meetings with industry representatives on April 27, 2016. It was discussed with researchers, health professionals and patient groups on April 28, 2016. Written comments received from the public by May 24, 2016 were considered in revising this guidance document.

A summary of comments received is available upon request.

Who should be using this document

This guidance document is for:

  • health researchers
  • health professionals
  • patient groups
  • pharmaceutical industries
  • medical device industries

In this document

In the guidance document for the disclosure of Confidential Business Information, you will find the following information:

  • introduction
  • paragraph 21.1(3)(c) of the Food and Drugs Act
  • principals and considerations for Health Canada's exercise of the authority under paragraph 21.1(3)(c) of the Food and Drugs Act
  • protection of personal information and respecting participant's informed consent
  • protection against commercial use
  • maintaining confidentiality of disclosed information
  • process to review requests for disclosure
  • requirements for persons requesting disclosure of confidential business information under paragraph 21.1(3)(c)
  • findings generated from disclosed information
  • forms and additional information:
    • review process flow chart
    • tools for finding regulatory information

Download PDF (258 KB, 29 pages)

Details and history

Published:
March 10, 2016
Updated:
March 10, 2017
Consulted:
March 10, 2016
Part of topic(s):
Drugs and health products

Contact us

Email: rmod_stakeholders-intervenants_dgro@hc-sc.gc.ca

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