Preclearance Procedure & Operations

Helpful pointers about the submission process

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Dannie NewmanPAAB Reviewerdannien@paab.ca

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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 review@paab.ca 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!