279 - Dear Concern, What are the time lines and submission procedures in canada. what are the guidelines for OTS products in Health Canada (submission only)

  • The following response was drafted by our file coordinators. Please contact Laurie or Sabrina at the PAAB office if you have any questions. Submissions which require full review will receive a first response within 10 business days. Direct to Consumer pieces and Opinion requests receive a first response within 4 business days. Subsequent responses will be received in 3 business days.You may submit to PAAB for review, finalized copydeck or layout for the initial review, copydeck to be followed by a final layout prior to approval of an advertising piece. Please include the most recent product monograph and the Health Canada approved letter which supports this monograph. All references should be uploaded to the electronic submission and cross referenced on the copydeck or layout in a manner directing us precisely to the support for each claim. Responses will be emailed to the current email address that we have for your personal registration within the efile system. The final approval letter will contain your PAAB acceptance ID # for future reference. An invoice initiated at the time that the first response has been sent to you. For a more detailed explanation of the submission procedures, please refer to the Submissions Guidance Document on our website.