Qualifying notice for Thiotepa for Injection USP

Therapeutic Products Directorate
Holland Cross, Tower "B"
6th Floor, 1600 Scott Street
Address Locator #3106B
Ottawa ON K1A 0K9

Dossier ID: e238038
Control #: 238038

[name of employee removed]
[title of employee removed]
[name of company removed]

Dear [Name of employee removed]:

This Notice of Compliance with Conditions-Qualifying Notice (NOC/c-QN) is to advise you that information submitted in support of the New Drug Submission for Thiotepa for Injection USP, control number 238038, for the indication in combination with other chemotherapeutic products as part of a high-dose chemotherapy (HDCT) consolidation regimen followed by autologous stem cell transplantation (ASCT) for adult patients with central nervous system (CNS) lymphoma, qualifies to be considered for authorization under the Notice of Compliance with Conditions (NOC/c) Policy. In keeping with the provision outlined in Part C, Section C.08.002.1 (3) (d) of the Food and Drug Regulations, the following additional information is required to complete the assessment:

  1. A letter, signed by the Chief Executive Officer, or designated signing authority of [name of company removed], indicating that they agree to have this submission considered under the NOC/c Policy. [name of company removed] should be reminded that in agreeing to accept a Notice of Compliance (NOC) under the NOC/c Policy, [name of company removed] consents to the posting of this NOC/c-QN on Health Canada's website once market authorization has been received.
  2. A Letter of Undertaking signed by the Chief Executive Officer, or designated signing authority of [name of company removed] having a form and content satisfactory to Health Canada to provide the following:

Post market safety monitoring

  1. Provision of bi-annual Periodic Safety Update Reports (PSUR-Cs) or Periodic Benefit Risk Evaluation Reports (PBRER-Cs) in a manner deemed consistent with E2C ICH Guidelines, until such time as all conditions for the Canadian Reference Product market authorizations under the NOC/c policy have been removed. The bi-annual PSUR-Cs or PBRER-Cs should include cumulative data on relevant unlisted Adverse Reactions (ARs) from the date of marketing to the time of the report.
  2. Notification and reporting on specific issues of concern as outlined in Section 3.4.4, Post-Market Commitments: Notification and Reporting of Specific Issues of Concern, of the Health Canada NOC/c revised policy dated June 30, 2011.
  3. Reports of all serious ARs that occurred in Canada and all serious unexpected ARs that occurred outside of Canada should be forwarded within 15 days to the Marketed Health Products Directorate, in accordance with current Food and Drug Regulations (C.01.017) and Guidelines (Guidelines for Reporting Adverse Reactions to Marketed Drugs, March, 2011).

I wish to advise you that this letter is being issued in accordance with Health Canada's Notices to Stakeholder dated April 2nd, 2008 and March 17, 2009. You are instructed to submit a complete response (refer to Guidance for Industry: Notice of Compliance with Conditions, similar to the innovator) to the outstanding information within 30 calendar days of the date of this letter directly to the Office of Submissions and Intellectual Property (OSIP) via the Common Electronic Submissions Gateway using Regulatory Enrolment Process.

In order to facilitate and ensure proper processing of your response, please include a revised Submission Certificate, quoting the product name, assigned dossier ID and control number of the original submission.

Sincerely,

[name of employee removed]
[title of employee removed]
JPS/res

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