Fair Balance (FB) - PAAB Training Portal

Preclearance Procedure & Operations
Helpful pointers about the submission process
Dannie Newman
PAAB Reviewer
[email protected]
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 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
General Requirements for a new
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 - 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
• 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
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
• 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
Cover letter
Product Monograph & NOC/NOL
Copydeck (finalized)
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
– highlighted in a different colour from unsolicited
• 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
– Where copy is removed, indicate with strikethroughs
Not like this
Revised Copydeck
Solicited revisions
Solicited revisions
• 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
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!

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