1. Preclearance Procedure & Operations Helpful pointers about the submission process 1 Dannie Newman PAAB Reviewer dannien@paab.ca

2. 2 PAAB Submission Procedure Key Steps in PAAB Approval Process – General Timelines and services available How submission errors affect timelines Tips to save time! – Reasons for having files returned – When should files be separated/submitted as separate efiles

4. Key Steps in PAAB Approval Process Pre Submission Available Services General Questions Opinion Requests Billable Meetings

5. PAAB receives submission Create a Complete Submission! Cover Letter Regulatory Documents (PM, NOC) References Copydeck Information Architecture Do not submit separate projects within the same efile Key Steps in PAAB Approval Process

6. Assignment of submission to reviewer

7. Reviewer sends PAAB letter Key Steps in PAAB Approval Process

8. Clarification calls with reviewer Clarification Calls: Escalation Calls: If the client does not understand the PAAB review comment When? After receiving a PAAB letter about the same issue which was discussed on the phone with the reviewer Who? Deputy Commissioner Reviewer Client and Manufacturer Key Steps in PAAB Approval Process

9. Client submits revised APS Tips when responding to PAAB letters: Include the following: Itemized response letter Highlight revisions (solicited & unsolicited) Provide highlighted references Key Steps in PAAB Approval Process

10. Acceptance number provided Key Steps in PAAB Approval Process

11. File submitted for review & assigned to reviewer Annotated TMA was not submitted, file sent back as incomplete PAAB sends 1 st response letter 5 days File resubmitted to PAAB with revisions PAAB sends 2 nd response letter File resubmitted to PAAB 6 days 3 days

12. File resubmitted to PAAB with revisions 3 days PAAB sends 3 rd response letter (unsolicited revisions) File resubmitted to PAAB with revisions English accepted- request French copy 2 days French copy submitted for review File Approved 2 days Total PAAB Time = 21 days

13. File submitted for review & assigned to reviewer Annotated TMA was not submitted, file sent back as incomplete File resubmitted to PAAB PAAB sends 1 st response letter 5 days File resubmitted to PAAB with revisions PAAB sends 2 nd response letter 6 days 3 days

14. File resubmitted to PAAB with revisions 3 days PAAB sends 3 rd response letter (unsolicited revisions) File resubmitted to PAAB with revisions English accepted- request French copy 2 days French copy submitted for review File Approved 2 days Total PAAB Time = 21 daysTotal PAAB Time = 21 days 13 days

15. Submission Tips & Time Savers 1.Make sure that new submissions are complete 2.Provide back files 3.Highlight all revisions (inform us of unsolicited changes) 4.Highlight all references 5.Ensure all APS elements are clear to PAAB (e.g. tags, pop- ups, links…) right from the initial submission 6.Include a letter of response identifying all actions taken (or not taken) in response to PAAB comments 7.Consider if the content should be split into multiple files

16. Questions