Template authorizing sharing of information

Instructions

To complete this form:

• copy and paste the template provided on this page into a word processing document 
• fill in your information where required
• save this document as a PDF
• include this document as a regulatory activity in your:
  • New Drug Submission
  • or Supplemental New Drug Submission

Template

This template applies to the Notice to industry: Aligned reviews between Health Canada and health technology assessment organizations.

Date: [MM/DD/YY]

Reference: [Brand name, common name, Health Canada control number (if available)]

This letter authorizes the sharing of certain information set out below (including confidential business information as defined in section 2 of the Food and Drugs Act (R.S.C., 1985, c. F-27)) with respect to the drug submission for “[Submission type], [Brand name, common name, medicinal ingredient(s), control number [NUMBER] (if available)/E-identifier: eXXXXXX]” (the “Product”) between Health Canada (HC), and the Canadian Agency for Drugs and Technologies in Health (CADTH), and l’Institut national d’excellence en santé et en services sociaux (INESSS) (hereinafter referred to as Health Technology Assessors (HTAs)). This letter does not serve to allow the sharing of this information between HTAs.

Specifically, [name of manufacturer] authorizes meetings of HC and HTAs, and the sharing of information and documents (final and draft versions) related to the Product, including:

• HC and HTA Review Reports
• HC Reports (including, but not limited to, Manager’s Memos, Executive Summaries, and Priority Review request assessments (may be under separate control number))
• Draft Summary Basis of Decision
• Meeting Minutes (may be under a separate control number)
• Questions and responses related to the review of the Product 
• Product Monograph
• Submission Status

[Manufacturer Name] understands and acknowledges that once HC shares information (including confidential business information) with HTAs, the following HTAs may engage in further sharing of this information solely with the entities specified below, and solely in accordance with the published policies and any applicable legislation governing the treatment of confidential information by the HTAs:

CADTH

• Participating Federal drug plans, P/T Ministries of Health and Provincial Cancer Agencies
• F/P/T governments, including their agencies and departments
• P/T health authorities, including regional health authorities
• Pan-Canadian Pharmaceutical Alliance (pCPA) Office

INESSS

• INESSS may include the above information in their evaluation of the product or in the notice and/or recommendation submitted to the Quebec Minister of Health and Social Services, being expressly understood by the Manufacturer that, according to its enabling act, INESSS shall publish the notices and recommendations it makes within 30 days after sending them to the Minister

This authorization remains valid until such time as it is revoked by the Manufacturer, in writing to HC: [Director of the Office of Submissions and Intellectual Property, Therapeutic Products Directorate, Health Canada].

It is understood and acknowledged by the Manufacturer that this authorization for the sharing of information or any subsequent revocation of this authorization does not operate to authorize or prevent HC from sharing information (including confidential business information) that HC is otherwise legally authorized to disclose.

It is confirmed that the wording of this consent letter has not been modified in any way by the Manufacturer from the Health Canada template, other than submission identification and contact information.

Duly executed by [print name], an authorized representative of [name of Manufacturer].

I [Name and Title of Senior Official of Manufacturer of Product], represent and warrant that I have the authority to give this consent on behalf of [name of Manufacturer].

[Signature]