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Health Canada Guidance Document on the Disclosure of Confidential Business Information – March 10, 2017

March 10, 2017
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Market Access News
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Posted by MORSE Team - < 1 min read.

Health Canada Update

 

On March 10, 2017, Health Canada issued a guidance document which describes how it discloses confidential business information (CBI). This guidance document is meant for:

  • health researchers,
  • health professionals,
  • patient groups,
  • pharmaceutical industries, and
  • medical device industries.

The federal Minister of Health is authorized to disclose CBI to people to protect or promote public health or safety. As noted on the Health Canada website:

“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.”

For more information you can access the guidance document on Health Canada’s website

 

To receive updates similar to this one please be sure to sign up for Market Access Signals, our free e-mail newsletter service.

 

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Health Canada Guidance Document on the Disclosure of Confidential Business Information – March 10, 2017
Private
Public
Private

INESSS
CADTH

HTA

pCPA

Public Payers

Health Canada

Patients

Private Payers

PMPRB

Public
INESSS
CADTH

HTA

pCPA

Public Payers

Health Canada

Patients

Private Payers

PMPRB
Public
Private
Public
INESSS
CADTH

HTA

pCPA

Public Payers

Health Canada

Patients

Private Payers

PMPRB
Private

INESSS
CADTH

HTA

pCPA

Public Payers

Health Canada

Patients

Private Payers

PMPRB