- Leap 3 5 2 – Comprehensive File Management Application Template
- Leap 3 5 2 – Comprehensive File Management Application Download
- Leap 3 5 2 – Comprehensive File Management Application Form
From Health Canada
Overview
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Who this guide is for
Leap 3 5 2 – Comprehensive File Management Application Template
- Sponsors of pharmaceuticals, biologics, and radiopharmaceutical drugs for human use
In this guide
- 1. Introduction
- 5. Classification of a therapeutic product
- 6. Specific submission/application pathways
- 7. Guidance for implementation
- 7.1 Pre-Submission or pre-application meetings
- 8. Filing of information to Health Canada
- 9. Submission/application processing
- 10. Screening of submissions/applications
- 10.1 Screening of a submission/application during the Screening 1 period
- 10.2 Solicited Information
- 10.2.3 Screening Deficiency Notice (SDN)
- 11. Scientific Review of submissions/applications
- 11.1 Scientific Review process
- 12. Solicited information during the Scientific Review
- 12.1 Solicited information
- 12.1.3 Notice of Deficiency (NOD) - NDS, SNDS, ANDS, SANDS or an Application for a DIN (DINA, DINB, DIND)
- 12.1 Solicited information
- 13. Completion of the Scientific Review of a submission/application
- 13.6 Notice of Non-Compliance (NON) - NDS, SNDS, ANDS, SANDS, or an Application for a DIN (DINA, DINB, DIND)
- 14. Unsolicited information
- 14.1 Safety information
- 14.2 Foreign regulatory information
- 15. Refiled submissions or applications
- 17. Accessing submission information
- Appendix 1
- Appendix 2
- Appendix 3
- Appendix 4
- Appendix 5
- Appendix 6
- Appendix 7
Download PDF (583 KB, 61 pages)
Details and history
Leap 3 5 2 – Comprehensive File Management Application Download
- Published: Pre 1993/12/19
- Updated: 2019/07/25
- Consulted: 2018/10/25
- Part of topic(s): Guidance on legislation
For assistance
Contact us:
Leap 3 5 2 – Comprehensive File Management Application Form
Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Canada
1600 Scott Street
Holland Cross, Tower B
2nd Floor, Address Locator 3102C1
Ottawa, Ontario
K1A 0K9
Facsimile: 613-941-1812
E-mail: [email protected]
Therapeutic Products Directorate
Health Canada
1600 Scott Street
Holland Cross, Tower B
2nd Floor, Address Locator 3102C1
Ottawa, Ontario
K1A 0K9
Facsimile: 613-941-1812
E-mail: [email protected]