Informal Request for ATI Records Previously Released

Organization: Health Canada

Year: 2023

Month: November

Request Number: A-2023-000149

Request Summary: The initial cover letter indicating the brand name of the reference drug product and the dosage form of the generic drug in Health Canada’s list of “Generic Drug Submissions Under Review” dated 2023-03-24 for the medicinal ingredient Enzalutamide; The Screening Acceptance Letter from Health Canada to the generic drug manufacturer confirming completion of screening of the Abbreviated New Drug Submission (ANDS) for Enzalutamide; The strength (s) and dosage form of any and all generic drugs in Health Canada’s list of “Generic Drug Submissions Under Review” dated 2023-03-24 having the medicinal ingredient Enzalutamide.; The Canadian Reference product used to support of any and all generic drugs in Health Canada’s list of “Generic Drug Submissions Under Review” dated 2023-03-24 having the medicinal ingredient Enzalutamide.; Any information pertaining to a Risk Management Plan (RMP) submitted to support of any and all generic drugs in Health Canada’s list of “Generic Drug Submissions Under Review” dated 2023-03-24 having the medicinal ingredient Enzalutamide.

Disposition: Disclosed in part

Number of pages: 77

Back to Search 

Request a copy of records

Availability of records are subject to retention timelines as established by institutions. Requests made through this form are considered informal requests and are not subject to the same requirements as requests under the Access to Information Act. For additional information, please see the “About Access to information and privacy” webpage.

Personal information that you provide is protected under the federal Privacy Act. Please do not include sensitive personal information in the message, such as your Social Insurance Number, personal finance data, medical or work history, or the personal information of other individuals.

 
Read the Privacy Statement for this page.

The collection and use of your personal information is authorized by the Financial Administration Act. Collection and use of your personal information for this site is in accordance with the federal Privacy Act. Your personal information is used  to validate your use of GC datasets and for information on the development of the GC open data initiative, and may also be used to evaluate the effectiveness of the program in responding to client needs. In exceptional circumstances (e.g. network intrusion, or of individuals who make inappropriate remarks or threats, etc.), personal information may be disclosed without your consent pursuant to subsection 8(2) of the Privacy Act.

Any personal information that may be collected is described in the Standard Personal Information Banks entitled Public Communications, PSU 914, and Outreach Activities, PSU 938, which can be found in the Treasury Board of Canada Secretariat (TBS) publication: InfoSource.

Under the Privacy Act, you have the right of access to, and correction of, your personal information, if you have provided any. Note however, that to exercise either of these rights; you must make a request for access to your personal information. For more information about your right of access, please read about the Access to Information Program.

Any questions, comments, concerns or complaints you may have regarding this Statement, your privacy rights and the Privacy Act may be directed to the TBS Access to Information and Privacy Coordinator by email at atip.aiprp@tbs-sct.gc.ca or by calling 613-946-6260 or 1-866-312-1511. If you are not satisfied with TBS' response to your privacy concern, you may wish to contact the Office of the Privacy Commissioner by email at info@priv.gc.ca or by telephone at 1-800-282-1376. You have the right to complain to the Office of the Privacy Commissioner about TBS' handling of your personal information.

Select the category that best describes you.
?

This information is collected for statistical purposes and is published annually on the Government of Canada Info Source website. (www.infosource.gc.ca)

Academia: Those who are engaged in higher education and who require information for research purposes.

Business (Private Sector): Those who are employed by the private sector, including lawyers and consultants, and who require information for their business or on behalf of another individual.

Media: Those who are employed by a radio or television company, a newspaper or magazine, or any online newspaper or blog, etc., and who require information for media purposes.

Organization: Those who are working or volunteering for an organization and who require information for that organization.

Member of the Public: All other members of the public who require information for their own purposes.

Please note To the extent possible, the institution will return the requested records in the format selected, but it may not be able to accommodate all electronic formats due to size limitations.
Explain what you want or why you are contacting this organization.
Address
State/Province
Please Note: Institutions will work to respond to your request for this previously released package as soon as practical.
Date modified: