145 - When is the time one can submit a docket before the Holidays? Are you open between Christmas and New Year's? If so, do you accept submissions at this time? Also, does the rule of 2 for initial docket submission still apply? Is the queue always 10 days for every first submission within that docket?
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As our submission process is fully electronic, you may submit new dockets at any time, day or night. The eFile system is fully operational 24/7. The PAAB office will be closed for the holidays on Friday Dec. 24, 2010 at noon and will reopen for business on Monday Jan. 3, 2011. The last day to submit a new eFile in order to ensure a first response before we close on the 24th, is Dec. 10, 2010. With respect to the "rule of 2 for initial docket submissions", I believe you are referring to pre-NOC submissions. You can submit up to 2 Pre-NOC pieces for review, as long as the monograph is at "FINAL DRAFT stage" with Health Canada. Pre-NOC pieces are not bound by the 10 day timeline for first response. For more information regarding pre-NOC submissions, please refer to the document "Administrative Guideline for the review of Pre-NOC advertising submissions" on the PAAB website There is no limit to the number of submissions you can make at any one time for APS promoting products/indications that have Health Canada approval. The PAAB will provide a first response within 10 business days. However, the timeline for response for Direct To Consumer pieces and Opinion requests is 4 business days.Please call the PAAB office if you have any further questions.
