Disclosure of confidential business information
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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
- Who should be using this document
- In this document
- Details and history
- Contact us
- Related information
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: hc.clinicaldata-donneescliniques.sc@canada.ca
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