- Leap 3 5 2 – Comprehensive File Management Application Template
- Leap 3 5 2 – Comprehensive File Management Application Pdf
- Leap 3 5 2 – Comprehensive File Management Application Download
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From Health Canada
Overview
Filemaker pro 17 advanced 17 0 4 400 download free. This guidance document gives sponsors and Health Canada staff operational direction and guidance when managing information submitted in accordance with the Food and Drugs Act and Regulations.
Who this guide is for
- 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)
Leap 3 5 2 – Comprehensive File Management Application Template
Details and history
- Published: Pre 1993/12/19
- Updated: 2019/07/25
- Consulted: 2018/10/25
- Part of topic(s): Guidance on legislation
For assistance
Leap 3 5 2 – Comprehensive File Management Application Pdf
Contact us:
Leap 3 5 2 – Comprehensive File Management Application Download
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]