Request for disclosure of confidential business information (CBI)
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Why we disclose confidential business information, who is eligible to request it and how to submit a request.
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About confidential business information (CBI)
Confidential business information (CBI) is included in the regulatory documents companies must submit to Health Canada. These documents are used to evaluate the safety, effectiveness and quality of a therapeutic product.
The Food and Drugs Act gives Health Canada the authority to disclose CBI to certain people to protect or promote public health and safety.
To help clarify our process for reviewing requests for disclosure of CBI, we have created a guidance document with information about how we make decisions.
Who is eligible to request CBI
To obtain CBI, you must be someone whose work helps to protect or promote public health or safety. You must also show how your use of the CBI would help protect or promote public health or safety. For more information about how to request and receive CBI, review our guidance document.
How to submit a request
To request CBI you must provide information about your qualifications and about how you plan to use the CBI. Please make your information request as specific as possible. The guidance document includes resources for identifying regulatory information held by Health Canada.
We encourage you to use the request form to provide information that Health Canada needs to review your request.
If you have questions or comments on submitting a request, email us at hc.clinicaldata-donneescliniques.sc@canada.ca.