Notice of eligibility for Thiotepa for Injection, BP

2023-05-23 20:00:00

Pharmaceutical Drugs Directorate
Holland Cross, Tour B
1600 Scott Street, 6th Floor
3106B Address Locator
Ottawa ON K1A 0K9

File number: HC6-024-e256254
Control number: 256254

Hikma Canada Limited
[nom de l’employé enlevé]
[le titre de l’employé enlevé]

Hikma Pharmaceuticals (Portugal), SA
Fervença / Estrada do Rio da Mó, nº 8, 8A & 8B
Terrugem SNT, Lisboa, Portugal
2705-90
Fax #: [phone]

Madame [nom de l’employé enlevé]:

This notice of eligibility for a Notice of Compliance with Conditions (AA-NOC-C), issued in accordance with Health Canada’s Guidance Document: Notice of Compliance with Conditions (NOC-C), is intended to inform you that information submitted in support of the Abbreviated New Drug Submission (ANDS) for Thiotepa for Injection, BP (thiotepa), control number 256254, indicated in combination with other chemotherapy products as part of a consolidation regimen high-dose chemotherapy (CTHD), prior to autologous stem cell transplantation (ASCT) for adult patients with central nervous system (CNS) lymphoma, are eligible for approval under the guideline aforementioned. In accordance with the provisions of this guideline, the following additional information is required to complete the evaluation of your submission:

1. A letter, signed by the CEO or designated signing officer of Hikma Canada Limited stating that you agree to the submission being reviewed under the Guideline: Notice of Compliance with Conditions (NOC/C). Please remember that by agreeing to receive a Notice of Compliance (NOC) under this guidance, Hikma Canada Limited consents to the posting of this NOA-NOC-C on the Health Canada website once marketing authorization received.
2. A draft letter of commitment signed by the CEO or designated signing officer of Hikma Canada Limited, in format and content satisfactory to Health Canada, as set out in the Guidance Document: Notice of Compliance with Conditions (NOC -C), and stating in particular a commitment to provide the following information:

Safety monitoring

1. Report all serious adverse reactions (ARs) that occurred in Canada and all serious unexpected ARs that occurred outside of Canada within 15 days to the Marketed Health Products Directorate. Reports of adverse events and AEs related to marketed drugs occurring during confirmatory studies subject to clinical trial applications, as indicated in the Letter of Undertaking, must be reported in accordance with Section 3.4. 1 of the Guidance Document: Notice of Compliance with Conditions (NOC/C) and according to applicable regulations and guidelines (for example, the Reporting of Adverse Reactions to Marketed Health Products – Guidance Document for Industry and Guidance for Clinical Trial Sponsors: Clinical Trial Applications).
2. Submit Periodic Safety Update Reports or Periodic Benefit-Risk Assessment Reports for products associated with a NOC-C (RPPV-C or RPEAR-C) twice a year, until the conditions associated with marketing authorization is withdrawn. RPPV-C/RPEAR-C should be prepared according to ICH E2C (R1) and E3C (R2) guidelines, including format and content, in accordance with Section 3.4.2 of the Guideline: Notice of Compliance with Conditions (NOC-C). Please note that once all commitments have been fulfilled, Periodic Benefit-Risk Assessment Reports – Pharmacovigilance (RPEAR-PV) or Periodic Pharmacovigilance Reports (RPPV-PV) must be submitted as per regulations. (subsection C.01.018(4)), upon request or in situations where the MAH identifies negative safety findings or significant changes in the overall benefit-risk profiles and pharmacovigilance of the product.
3. Comply with notification and reporting of concerns on specific issues, in accordance with section 3.4.4 of the Guidance: Notice of Compliance with Conditions (NOC/C).

Additional Information

4. Obtain prior clearance from the Pharmaceutical archyde news Advisory Board (PAAB) for all promotional material relating to Thiotepa for Injection, BP (thiotepa), in accordance with section 5.1 of the Guidance Document: Notice of Compliance with Conditions (NOC/C) . For more information on regulatory requirements, please see:
5. Provide copies of all market authorizations for Thiotepa for Injection, BP (thiotepa) granted by any other drug regulatory authority, as per section 4.6 of the Guidance Document: Notice of Compliance with Conditions (NOC/c) .

I wish to inform you that this Notice of Eligibility is issued under the Guidance Document: Management of Drug Submissions and Applications and the Guidance Document: Notice of Compliance with Conditions (NOC/c) respectively.

Please submit all missing information (see Guidance Document: Notice of Compliance with Conditions (NOC/C)) in the 30 calendar days following the date of this letter, directly to the Office of Submissions and Intellectual Property (OBPI), through the Common Electronic Application Portal, using the Regulatory Registration Process.

In order to facilitate and ensure the proper processing of your response, please indicate the name of the product, the file number assigned to it, as well as the control number of the initial submission.

Please accept the expression of my best feelings.

Karen Reynolds
Executive Director
Pharmaceutical Drugs Directorate

1685049221
#Notice #eligibility #Thiotepa #Injection