Preclearance Procedure & Operations
Helpful pointers about the submission process
Dannie Newman
PAAB Reviewer
dannien@paab.ca
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 review@paab.ca 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!