Preclearance Procedure & Operations Helpful pointers about the submission process Dannie Newman PAAB Reviewer [email protected] 1 PAAB Submission Procedure • New Submission/First review – General Requirements/Timelines • Submitting Revisions – General Requirements/Timelines • Time Savers! – Reasons for having files returned – When should files be separated/submitted as separate efiles 2 Efiles System • Electronic submission using efiles – See www.paab.ca for tutorial – Initial set-up: contact Glenn Golaz – All submission queries: email [email protected] or contact Laurie Johns, Sabrina Hack, Estelle Parkin • All submissions (including references) are confidential 3 General Requirements for a new submission… Cover letters • Every new submission should be accompanied by a cover letter – What documents have been included in the submission – Describe how the tool will be used (i.e. rep directed or HCP driven tool) – Is it a renewal? Provide previously approved efile # – Is there pick up from previously approved efiles? – Identify any special considerations Regulatory Requirements • Product Monograph (PM) – Most current – Submission control must match on PM & Letter • Health Canada approval letter – NOC, NOL NOC - Notice of Compliance, NOL - No objection Letter Annotated PM • An annotated PM highlights all additions and deletions made Annotated PM • With each new submission for the first 3 months after notifying PAAB of the change • For renewals if PM updated since APS accepted PM update during an ongoing review may incur a new file # and fee Provide confirmation where relevant for the PM update approval e.g. NOL or Regulatory affairs letter to confirm (level III of IV change) English Copy • Copydeck (and/or layout) – format used for the initial submission should be maintained for the duration of the review process – finalized before submitting to PAAB • Shouldn’t be any to-be-determined elements • Multiple options for any copy • Medical Regulatory must have signed off on piece prior to submitting – Identify previously approved copy – Reference all claims Copydeck: Referencing Each claim or presentation should be clearly referenced. • Clear identification of the reference source, page number and section of the page – Don’t just cite the source (s) (5-7) • References appear in a different colour from the advertising copy Copydeck: Referencing Clearly identify the reference source, page number and section of the page Example: Ref 1A, p. 151 Source – Ref 1 Section on the page (highlighted) - A Page # - p.151 Example: Based on efile 31223 Don’t stop here with the referencing References • The corresponding section(s) of the reference should be highlighted and labeled References in efiles • Name the file with the reference number and the title of the paper Ref 1 – Efficacy and safety of Product X Electronic Tools • Additional requirement for electronic tools (edetail aids, apps, websites) • Flow of information • Include the information architecture (i.e. sitemap, storyboard) Site Map & wireframe Summary: New submission requirements • • • • • Cover letter Product Monograph & NOC/NOL Copydeck (finalized) References Information architecture Timeline: Response from PAAB within ~10 business days. General Requirements for submitting revisions… Letters of response • Every re-submission should be accompanied by a letter of response – actions taken in response to PAAB comments – unsolicited changes etc. Revised Copydeck • All revisions should be highlighted on the copydeck – highlighted in a different colour from unsolicited changes • Only revisions and changes from the previous copydeck should be highlighted – Remove any residual highlights from previous versions of Apply revisions the copydeck throughout the piece – Where copy is removed, indicate with strikethroughs and highlighting Not like this Revised Copydeck Solicited revisions (additions) Solicited revisions (deletions) Unsolicited revisions References • Provide any new references • Same requirements apply to revisions, new copy must be clearly referenced. Each claim or presentation should be clearly referenced. • Clear identification of the reference source, page number and section of the page – Don’t just cite the source (s) (5-7) • Corresponding section of the reference highlighted and labeled Revised Copydeck Summary: Requirements for submitting revisions • Letter of response • Revised copydeck • References (include new references and highlight/label accordingly) Timeline: Response from PAAB within ~3 business days. To get to approval… • Clearance is conditional on compliance with all applicable PAAB codes – i.e. requested revisions have been completed • French copy provided if bilingual • Complete Layout required – Including any audio or animated features, video`s etc. Timesavers: Why are files returned? Incomplete submission: • Have I included all the information discussed in the “New submission/First review” section? File needs to be split into separate files: • Is there more than one regulatory audience? • Is information accessed through different mediums (i.e. website with emails, downloadable documents)? • Are there different products discussed? If in doubt, call us!