preclearance procedure & operations helpful pointers about the submission process 1 dannie...
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Preclearance Procedure & Operations
Helpful pointers about the submission process
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Dannie NewmanPAAB [email protected]
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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
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
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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 approvale.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 1Section on the page (highlighted) - APage # - 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 (e-detail 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
the copydeck – Where copy is removed, indicate with strikethroughs and
highlighting
Apply revisions throughout the
piece
Not like this
Revised Copydeck
Unsolicited revisions
Solicited revisions (additions)
Solicited revisions (deletions)
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!