What are the requirements/limitations for emailing of Enrollment Forms to HCPs for the purpose of enrolling their patients in a PSP? We have developed an Enrollment Form (approved by PAAB) of which we have a version that is a writeable PDF (text fields can be filled out on the computer) to then be printed and signed, and would like to email this Enrollment Form to HCPs directly via the reps. Could you please inform me if this contravenes any PAAB regulation? I was unable to find anything in the PAAB code that would suggest this. Thank you!
PAAB approved print APS which are reformatted onto an electronic platform for further distribution by the sponsor require the PAAB review of the electronic format unless all of the following criteria are met:
- The PAAB approved APS is still within its approval period
- There have been no product monograph updates (or Health Canada warning letters) since approval of the original piece
- The same content/layout/flow is maintained as in the approved print APS. For example:
- Any size changes are directly proportional throughout the APS
- Content on the page are not repositioned to optimize for landscape/portrait mode
- No new functionality is added other than zoom-in and zoom-out. e.g. if scrolling functionality is added selectively to portions of a piece, the PAAB review is required to ensure it does not cause the Fair Balance prominence to become insufficient i.e.. the piece on the electronic platform would essentially be comprised of all scanned pages in same order as the print APS
- The APS context (e.g. branded vs unbranded) and the target audience are unchanged
In the scenario described above, the electronic piece which is now being distributed via email may have additional considerations such as the subject line, email body copy, and potential linkages (i.e. websites, other APS, etc.) within the piece which would require PAAB review. Once approved, distribution directly from reps to the healthcare professional would be acceptable.