2026-06-08 covid canada
Jun 08, 2026 08:50
· 27:14
· English
· Whisper Turbo
· 8 Speakers
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Showing only
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Speaker 2 (2026-06-08 covid canada)
Just give everyone another minute to join.
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Speaker 2 (2026-06-08 covid canada)
Just while everyone's joining,
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Speaker 2 (2026-06-08 covid canada)
I guess, we had a meeting last week,
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Speaker 2 (2026-06-08 covid canada)
you know, speaking on this.
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Speaker 2 (2026-06-08 covid canada)
So just to bring you up to speed from an ADK perspective,
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Speaker 2 (2026-06-08 covid canada)
we had this project,
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Speaker 2 (2026-06-08 covid canada)
I know, you know, you were involved last year on this,
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Speaker 2 (2026-06-08 covid canada)
but this is...
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Speaker 2 (2026-06-08 covid canada)
a product,
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Speaker 2 (2026-06-08 covid canada)
an EUA product that's only sold in Canada,
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Speaker 2 (2026-06-08 covid canada)
COVID -19 self -test,
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Speaker 2 (2026-06-08 covid canada)
that was transferred over to Galway in February of last year,
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Speaker 2 (2026-06-08 covid canada)
as Yannick can't meet the NDSAQ requirements to continue
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Speaker 2 (2026-06-08 covid canada)
to sell the product in Canada.
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Speaker 2 (2026-06-08 covid canada)
So we were progressing the activities to
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Speaker 2 (2026-06-08 covid canada)
commercialise the product and be manufactured ready from a Galway
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Speaker 2 (2026-06-08 covid canada)
ADK perspective,
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Speaker 2 (2026-06-08 covid canada)
and then the project was put on pause in October.
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Speaker 2 (2026-06-08 covid canada)
of last year but now it's been decided that we have to reinitiate
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Speaker 2 (2026-06-08 covid canada)
this product or sorry project and continue
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Speaker 2 (2026-06-08 covid canada)
with the commercialization of this product um
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Speaker 2 (2026-06-08 covid canada)
so last week we reset a couple of the actions from
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Speaker 2 (2026-06-08 covid canada)
a go away perspective and then today we'll be hoping to get some
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Speaker 2 (2026-06-08 covid canada)
due dates um from yourselves on the actions that are with abk
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Speaker 2 (2026-06-08 covid canada)
and
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Speaker 2 (2026-06-08 covid canada)
So I guess we can start initially with the ADK
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Speaker 2 (2026-06-08 covid canada)
Actions.
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Speaker 2 (2026-06-08 covid canada)
Yana,
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Speaker 2 (2026-06-08 covid canada)
do you have or do you want to provide a due date for
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Speaker 2 (2026-06-08 covid canada)
the creation of part numbers for
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Speaker 2 (2026-06-08 covid canada)
the labels?
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Speaker 1 (2026-06-08 covid canada)
Yes,
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Speaker 1 (2026-06-08 covid canada)
but if the labeling document was approved
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Speaker 1 (2026-06-08 covid canada)
or not,
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Speaker 1 (2026-06-08 covid canada)
I can create the codes.
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Speaker 1 (2026-06-08 covid canada)
So
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Speaker 2 (2026-06-08 covid canada)
how long does it take to create codes?
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Speaker 1 (2026-06-08 covid canada)
It's completed.
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Speaker 2 (2026-06-08 covid canada)
Yeah, how long does it take?
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Speaker 1 (2026-06-08 covid canada)
Well,
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Speaker 1 (2026-06-08 covid canada)
if the labelling has been approved,
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Speaker 1 (2026-06-08 covid canada)
I can initiate from now and I
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Speaker 1 (2026-06-08 covid canada)
will take at least 4 or 5 days.
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Speaker 1 (2026-06-08 covid canada)
Okay,
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Speaker 2 (2026-06-08 covid canada)
so we have the labelling is written for approval and we have it for due
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Speaker 2 (2026-06-08 covid canada)
date of the 15th.
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Speaker 2 (2026-06-08 covid canada)
So if we add the 15th,
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Speaker 2 (2026-06-08 covid canada)
if we add for the 22nd here then is that
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Speaker 1 (2026-06-08 covid canada)
okay?
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Speaker 1 (2026-06-08 covid canada)
Yeah.
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Speaker 2 (2026-06-08 covid canada)
The labeling, yeah.
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Speaker 2 (2026-06-08 covid canada)
Okay, great.
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Speaker 2 (2026-06-08 covid canada)
And then for the PPS update,
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Speaker 2 (2026-06-08 covid canada)
I don't know,
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Speaker 2 (2026-06-08 covid canada)
there's probably some name to change on this now,
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Speaker 1 (2026-06-08 covid canada)
but...
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Speaker 1 (2026-06-08 covid canada)
Yes.
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Speaker 2 (2026-06-08 covid canada)
How long?
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Speaker 1 (2026-06-08 covid canada)
Yeah,
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Speaker 1 (2026-06-08 covid canada)
sorry. Yeah,
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Speaker 1 (2026-06-08 covid canada)
I changed the name,
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Speaker 1 (2026-06-08 covid canada)
the response to owner from now.
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Speaker 1 (2026-06-08 covid canada)
And the PPS creation will take seven
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Speaker 1 (2026-06-08 covid canada)
days after the creation calls.
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Speaker 1 (2026-06-08 covid canada)
And
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Speaker 2 (2026-06-08 covid canada)
the BMR?
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Speaker 2 (2026-06-08 covid canada)
And they can happen
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Speaker 2 (2026-06-08 covid canada)
together, the PPS and the CMR can be updated together.
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Speaker 1 (2026-06-08 covid canada)
This
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Speaker 1 (2026-06-08 covid canada)
is PPS.
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Speaker 2 (2026-06-08 covid canada)
Okay,
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Speaker 2 (2026-06-08 covid canada)
so if we have here for the 22nd of June
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Speaker 1 (2026-06-08 covid canada)
and then the
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Speaker 2 (2026-06-08 covid canada)
PPS for the 29th,
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Speaker 2 (2026-06-08 covid canada)
Seven working days,
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Speaker 2 (2026-06-08 covid canada)
you know,
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Speaker 1 (2026-06-08 covid canada)
is it?
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Speaker 1 (2026-06-08 covid canada)
Doesn't
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Speaker 2 (2026-06-08 covid canada)
need longer than a full week.
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Speaker 2 (2026-06-08 covid canada)
We go from the 22nd,
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Speaker 2 (2026-06-08 covid canada)
we put it in for the 1st of July.
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Speaker 1 (2026-06-08 covid canada)
I think they will be better.
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Speaker 1 (2026-06-08 covid canada)
Okay.
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Speaker 2 (2026-06-08 covid canada)
And then,
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Speaker 2 (2026-06-08 covid canada)
do you have holidays in July?
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Speaker 2 (2026-06-08 covid canada)
Is there a national holiday?
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Speaker 2 (2026-06-08 covid canada)
Any chance in ADK during any of these days that I'm putting down?
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Speaker 2 (2026-06-08 covid canada)
You might understand there isn't no any holiday.
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Speaker 2 (2026-06-08 covid canada)
Okay,
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Speaker 1 (2026-06-08 covid canada)
perfect.
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Speaker 2 (2026-06-08 covid canada)
Okay,
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Speaker 2 (2026-06-08 covid canada)
so we have the PPS for the 1st of July and then approximately 10
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Speaker 2 (2026-06-08 covid canada)
days later the BMR.
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Speaker 2 (2026-06-08 covid canada)
Great.
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Speaker 2 (2026-06-08 covid canada)
And then for the carton labels,
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Speaker 2 (2026-06-08 covid canada)
I know they had started before and there was a lot of discussions on that with yourself
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Speaker 1 (2026-06-08 covid canada)
and Isa.
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Speaker 2 (2026-06-08 covid canada)
Are they created?
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Speaker 2 (2026-06-08 covid canada)
I just didn't actually have the update for the carton labels.
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Speaker 3 (2026-06-08 covid canada)
What
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Speaker 2 (2026-06-08 covid canada)
if we have...
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Speaker 1 (2026-06-08 covid canada)
Is this for the shipping one?
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Speaker 1 (2026-06-08 covid canada)
It's not exactly the intermediate packaging.
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Speaker 1 (2026-06-08 covid canada)
It's the shipping one that Canada needed.
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Speaker 1 (2026-06-08 covid canada)
I need to check because I know one of the products they
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Speaker 1 (2026-06-08 covid canada)
said they didn't need it.
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Speaker 3 (2026-06-08 covid canada)
We did create
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Speaker 1 (2026-06-08 covid canada)
it for one and then for a second product it
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Speaker 1 (2026-06-08 covid canada)
was...
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Speaker 1 (2026-06-08 covid canada)
Dean did not require just a knife to have last
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Speaker 3 (2026-06-08 covid canada)
year. So
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Speaker 1 (2026-06-08 covid canada)
I think it might be this one because the other one is commercial.
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Speaker 3 (2026-06-08 covid canada)
Okay,
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Speaker 2 (2026-06-08 covid canada)
so if you can get back,
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Speaker 2 (2026-06-08 covid canada)
if you could follow them on today,
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Speaker 2 (2026-06-08 covid canada)
Aoife,
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Speaker 2 (2026-06-08 covid canada)
just so we have that,
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Speaker 2 (2026-06-08 covid canada)
but then...
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Speaker 1 (2026-06-08 covid canada)
I'm not sure who to go to.
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Speaker 1 (2026-06-08 covid canada)
I think it came through someone else in the group.
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Speaker 3 (2026-06-08 covid canada)
Sorry,
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Speaker 1 (2026-06-08 covid canada)
I'm not sure if it was
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Speaker 3 (2026-06-08 covid canada)
Aoife and
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Speaker 1 (2026-06-08 covid canada)
Alnor or...
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Speaker 1 (2026-06-08 covid canada)
I'm not sure where the information came from.
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Speaker 1 (2026-06-08 covid canada)
I just remember there was discussions on it last year and this product was different
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Speaker 1 (2026-06-08 covid canada)
to the Pambio COVID
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Speaker 1 (2026-06-08 covid canada)
flu.
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Speaker 3 (2026-06-08 covid canada)
So
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Speaker 2 (2026-06-08 covid canada)
how do we confirm it?
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Speaker 2 (2026-06-08 covid canada)
Sorry, I'm just not really clear on what the next step is.
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Speaker 1 (2026-06-08 covid canada)
Yeah,
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Speaker 1 (2026-06-08 covid canada)
I'm not sure who to confirm it with because it was,
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Speaker 1 (2026-06-08 covid canada)
I don't know,
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Speaker 1 (2026-06-08 covid canada)
for the Pambio one,
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Speaker 1 (2026-06-08 covid canada)
they were saying it was a shipping thing that they,
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Speaker 1 (2026-06-08 covid canada)
it was nice to have in the,
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Speaker 1 (2026-06-08 covid canada)
possibly the warehouse in Canada.
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Speaker 1 (2026-06-08 covid canada)
that they could just scan it and see what was in the shipping box.
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Speaker 3 (2026-06-08 covid canada)
But as it
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Speaker 1 (2026-06-08 covid canada)
was deemed a nice to have for one of the products,
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Speaker 1 (2026-06-08 covid canada)
we said we wouldn't be going ahead with it unless
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Speaker 1 (2026-06-08 covid canada)
that's changed.
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Speaker 3 (2026-06-08 covid canada)
Where has
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Speaker 2 (2026-06-08 covid canada)
it defined what's nice to have and what's the requirement in terms of those labels?
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Speaker 1 (2026-06-08 covid canada)
It was like a customer requirement,
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Speaker 1 (2026-06-08 covid canada)
not a right -to -three requirement.
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Speaker 1 (2026-06-08 covid canada)
Yeah.
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Speaker 2 (2026-06-08 covid canada)
But I think we had conversations about this and,
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Speaker 2 (2026-06-08 covid canada)
you know, correct me if I'm wrong,
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Speaker 1 (2026-06-08 covid canada)
but...
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Speaker 2 (2026-06-08 covid canada)
It was that we had to align with what ENA has done so far and it
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Speaker 2 (2026-06-08 covid canada)
was to create the label.
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Speaker 3 (2026-06-08 covid canada)
Yeah,
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Speaker 1 (2026-06-08 covid canada)
if you want to create the label,
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Speaker 1 (2026-06-08 covid canada)
yeah, we can.
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Speaker 3 (2026-06-08 covid canada)
Well,
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Speaker 2 (2026-06-08 covid canada)
I don't know when I rehash the conversations,
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Speaker 2 (2026-06-08 covid canada)
but if that's what we decided last year,
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Speaker 2 (2026-06-08 covid canada)
I remember there was a lot of conversations on that and some of them I wasn't
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Speaker 2 (2026-06-08 covid canada)
involved in, but if that's what they need,
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Speaker 2 (2026-06-08 covid canada)
the current bombs and
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Speaker 2 (2026-06-08 covid canada)
the current DMOs for...
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Speaker 2 (2026-06-08 covid canada)
the products we're currently selling,
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Speaker 2 (2026-06-08 covid canada)
then we match it.
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Speaker 3 (2026-06-08 covid canada)
I
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Speaker 2 (2026-06-08 covid canada)
actually thought we had created these labels,
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Speaker 2 (2026-06-08 covid canada)
Jan, because I thought Sarah had created them.
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Speaker 1 (2026-06-08 covid canada)
That was for the other product,
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Speaker 1 (2026-06-08 covid canada)
I think.
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Speaker 1 (2026-06-08 covid canada)
I could be wrong,
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Speaker 1 (2026-06-08 covid canada)
though, because there was two happening at the same time.
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Speaker 1 (2026-06-08 covid canada)
If we made it for one product,
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Speaker 1 (2026-06-08 covid canada)
it would make sense that we're making it for the other.
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Speaker 1 (2026-06-08 covid canada)
I guess I'm not sure we can
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Speaker 1 (2026-06-08 covid canada)
check with Sarah if this is something...
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Speaker 1 (2026-06-08 covid canada)
So this is the outer carton
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Speaker 1 (2026-06-08 covid canada)
labels, correct?
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Speaker 1 (2026-06-08 covid canada)
Because there was a whole question over that this is sort of in the grey area,
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Speaker 1 (2026-06-08 covid canada)
it's out of scope for the labelling procedure because
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Speaker 1 (2026-06-08 covid canada)
it's not considered product labelling.
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Speaker 3 (2026-06-08 covid canada)
Yeah,
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Speaker 1 (2026-06-08 covid canada)
and it's out of scope for the UDI one also because it doesn't,
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Speaker 1 (2026-06-08 covid canada)
the UDI wouldn't apply to the shipping one,
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Speaker 1 (2026-06-08 covid canada)
only an intermediary count.
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Speaker 1 (2026-06-08 covid canada)
I guess we just want to be consistent
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Speaker 1 (2026-06-08 covid canada)
though.
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Speaker 1 (2026-06-08 covid canada)
Yeah, well, we did create it for the other one,
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Speaker 1 (2026-06-08 covid canada)
so we can just create it for this one.
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Speaker 1 (2026-06-08 covid canada)
I just remember a conversation last year that it was at
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Speaker 1 (2026-06-08 covid canada)
one of the...
10:00
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Speaker 2 (2026-06-08 covid canada)
these meetings that it was stated that it was actually like a nice to have
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Speaker 2 (2026-06-08 covid canada)
and we didn't actually need it but if
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Speaker 2 (2026-06-08 covid canada)
we want it now that's that's fine i can check maybe they are created somewhere
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Speaker 4 (2026-06-08 covid canada)
sorry who
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Speaker 3 (2026-06-08 covid canada)
creates them is it the lm as in go
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Speaker 3 (2026-06-08 covid canada)
with da or is it is it adk well
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Speaker 5 (2026-06-08 covid canada)
all the udi should be assigned from lm
10:43
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Speaker 3 (2026-06-08 covid canada)
I can check with Sarah to see what we're doing.
10:47
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Speaker 1 (2026-06-08 covid canada)
Here they are here.
10:49
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Speaker 1 (2026-06-08 covid canada)
They're under complete.
10:51
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Speaker 1 (2026-06-08 covid canada)
So
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Speaker 1 (2026-06-08 covid canada)
this is just the wind shuttle for it,
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Speaker 1 (2026-06-08 covid canada)
but like the CO itself,
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Speaker 4 (2026-06-08 covid canada)
they
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Speaker 1 (2026-06-08 covid canada)
already are there.
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Speaker 1 (2026-06-08 covid canada)
So they have been created and they're implemented.
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Speaker 1 (2026-06-08 covid canada)
This is just for the wind shuttle request.
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Speaker 1 (2026-06-08 covid canada)
So I think based on that,
11:15
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Speaker 1 (2026-06-08 covid canada)
if we have created them,
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Speaker 1 (2026-06-08 covid canada)
are we saying we're moving forward with them?
11:22
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Speaker 1 (2026-06-08 covid canada)
Did you get that CO number?
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Speaker 3 (2026-06-08 covid canada)
Yeah, so they're accredited back last November.
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Speaker 3 (2026-06-08 covid canada)
Yeah,
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Speaker 1 (2026-06-08 covid canada)
yeah,
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Speaker 1 (2026-06-08 covid canada)
because I remember there was a whole thing with maybe one of the technical
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Speaker 1 (2026-06-08 covid canada)
files as well for submission that they wanted to kind of enable the nasal pharyngeal
11:40
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Speaker 1 (2026-06-08 covid canada)
as well and we created them.
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Speaker 4 (2026-06-08 covid canada)
So
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Speaker 1 (2026-06-08 covid canada)
I think, is it agreed then if we have the labels created
11:54
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Speaker 1 (2026-06-08 covid canada)
that we move forward with the windshield request or what would
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Speaker 1 (2026-06-08 covid canada)
change that?
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Speaker 1 (2026-06-08 covid canada)
My understanding was that we had agreed to move forward with it,
12:03
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Speaker 1 (2026-06-08 covid canada)
but I can go back over the minutes and double check.
12:05
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Speaker 1 (2026-06-08 covid canada)
But if we had created the labels,
12:07
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Speaker 1 (2026-06-08 covid canada)
it would seem that way.
12:08
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Speaker 1 (2026-06-08 covid canada)
So, please.
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Speaker 3 (2026-06-08 covid canada)
Can I just share my screen in a minute,
12:12
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Speaker 3 (2026-06-08 covid canada)
Gillian?
12:13
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Speaker 1 (2026-06-08 covid canada)
Sorry.
12:14
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Speaker 1 (2026-06-08 covid canada)
Yeah.
12:14
S…
Speaker 3 (2026-06-08 covid canada)
The screen
12:18
S…
Speaker 3 (2026-06-08 covid canada)
has been shared.
12:19
S…
Speaker 4 (2026-06-08 covid canada)
So,
12:22
S…
Speaker 3 (2026-06-08 covid canada)
this is the CO you're saying just for the Canadian SKU,
12:27
S…
Speaker 3 (2026-06-08 covid canada)
the outer shippers.
12:28
S…
Speaker 3 (2026-06-08 covid canada)
So, obviously,
12:28
S…
Speaker 3 (2026-06-08 covid canada)
this is the label.
12:29
S…
Speaker 3 (2026-06-08 covid canada)
So,
12:30
S…
Speaker 3 (2026-06-08 covid canada)
it has the 501.
12:32
S…
Speaker 3 (2026-06-08 covid canada)
So if we're going down the path for Canada just for
12:36
S…
Speaker 3 (2026-06-08 covid canada)
this label for the outer shipper,
12:39
S…
Speaker 3 (2026-06-08 covid canada)
are we going to do that same strategy for all countries and
12:43
S…
Speaker 3 (2026-06-08 covid canada)
all LM products?
12:44
S…
Speaker 3 (2026-06-08 covid canada)
Because that's a lot.
12:46
S…
Speaker 1 (2026-06-08 covid canada)
My understanding was that it was a customer requirement
12:50
S…
Speaker 1 (2026-06-08 covid canada)
for Canada.
12:51
S…
Speaker 1 (2026-06-08 covid canada)
That's why we were doing it.
12:53
S…
Speaker 1 (2026-06-08 covid canada)
And that's what the Yenna team had done.
12:55
S…
Speaker 1 (2026-06-08 covid canada)
I don't know about other products,
12:59
S…
Speaker 1 (2026-06-08 covid canada)
but this was.
13:01
S…
Speaker 1 (2026-06-08 covid canada)
Canada -specific and it was to match the current format of the product that we're currently selling
13:05
S…
Speaker 1 (2026-06-08 covid canada)
in Canada.
13:05
S…
Speaker 4 (2026-06-08 covid canada)
All
13:12
S…
Speaker 3 (2026-06-08 covid canada)
right. All right,
13:14
S…
Speaker 3 (2026-06-08 covid canada)
look, Chris,
13:16
S…
Speaker 3 (2026-06-08 covid canada)
maybe we have a conversation offline and just...
13:20
S…
Speaker 2 (2026-06-08 covid canada)
Yeah, yeah,
13:21
S…
Speaker 2 (2026-06-08 covid canada)
yeah, let's do it.
13:22
S…
Speaker 2 (2026-06-08 covid canada)
Yeah, because I get what you're saying and that there is a huge number of
13:26
S…
Speaker 2 (2026-06-08 covid canada)
different SKUs.
13:27
S…
Speaker 4 (2026-06-08 covid canada)
Yeah.
13:28
S…
Speaker 2 (2026-06-08 covid canada)
And just from an ADK perspective,
13:32
S…
Speaker 4 (2026-06-08 covid canada)
do you...
13:35
S…
Speaker 2 (2026-06-08 covid canada)
In ADK,
13:36
S…
Speaker 2 (2026-06-08 covid canada)
do you typically apply those labels to all products,
13:39
S…
Speaker 2 (2026-06-08 covid canada)
ships out of ADK,
13:41
S…
Speaker 2 (2026-06-08 covid canada)
those packaging labels?
13:43
S…
Speaker 4 (2026-06-08 covid canada)
We usually
13:47
S…
Speaker 5 (2026-06-08 covid canada)
assign only for a package ADI and if there is no
13:51
S…
Speaker 5 (2026-06-08 covid canada)
any other custom request,
13:52
S…
Speaker 5 (2026-06-08 covid canada)
we do not assign,
13:54
S…
Speaker 5 (2026-06-08 covid canada)
we do not create carton labels.
13:57
S…
Speaker 2 (2026-06-08 covid canada)
So it's only on,
14:00
S…
Speaker 2 (2026-06-08 covid canada)
sorry,
14:02
S…
Speaker 2 (2026-06-08 covid canada)
it's only on a thousand labels basis.
14:04
S…
Speaker 4 (2026-06-08 covid canada)
Yeah.
14:10
S…
Speaker 1 (2026-06-08 covid canada)
There was conversations with Yenna on this last year Grace where they
14:14
S…
Speaker 1 (2026-06-08 covid canada)
confirmed it was a customer requirement and that's what they were including for those reasons.
14:17
S…
Speaker 1 (2026-06-08 covid canada)
If you want to review internally and
14:22
S…
Speaker 1 (2026-06-08 covid canada)
get back and take that action to do that if it's not defined in
14:26
S…
Speaker 1 (2026-06-08 covid canada)
the procedure anywhere I'm not quite sure what else we can do but just
14:30
S…
Speaker 1 (2026-06-08 covid canada)
double check with.
14:32
S…
Speaker 1 (2026-06-08 covid canada)
Yeah, that's what they were doing,
14:33
S…
Speaker 1 (2026-06-08 covid canada)
but that is what they confirmed.
14:34
S…
Speaker 1 (2026-06-08 covid canada)
I think it was the only one who actually brought it to the table as a label that we needed
14:39
S…
Speaker 1 (2026-06-08 covid canada)
based on customer requirements because it wasn't on the actions
14:44
S…
Speaker 1 (2026-06-08 covid canada)
to complete last time.
14:45
S…
Speaker 1 (2026-06-08 covid canada)
So we added it in for that reason.
14:48
S…
Speaker 4 (2026-06-08 covid canada)
Okay,
14:55
S…
Speaker 1 (2026-06-08 covid canada)
but then in terms of the windshield requests,
14:58
S…
Speaker 1 (2026-06-08 covid canada)
you know,
14:59
S…
Speaker 1 (2026-06-08 covid canada)
for the...
15:00
S…
Speaker 6 (2026-06-08 covid canada)
The carton labels,
15:00
S…
Speaker 6 (2026-06-08 covid canada)
it shouldn't impact or does it impact?
15:04
S…
Speaker 6 (2026-06-08 covid canada)
Is the PPS just for the kit box
15:08
S…
Speaker 6 (2026-06-08 covid canada)
or does the PPS include shipping information too?
15:11
S…
Speaker 1 (2026-06-08 covid canada)
Can they go in parallel?
15:14
S…
Speaker 7 (2026-06-08 covid canada)
It's on the level of a carton.
15:17
S…
Speaker 7 (2026-06-08 covid canada)
So we need to add the carton labels on
15:21
S…
Speaker 1 (2026-06-08 covid canada)
the paper.
15:21
S…
Speaker 8 (2026-06-08 covid canada)
Iona,
15:24
S…
Speaker 8 (2026-06-08 covid canada)
these aren't the intermediary cartons?
15:27
S…
Speaker 4 (2026-06-08 covid canada)
These would be?
15:29
S…
Speaker 8 (2026-06-08 covid canada)
on the outer shipping box?
15:32
S…
Speaker 2 (2026-06-08 covid canada)
Yeah.
15:38
S…
Speaker 4 (2026-06-08 covid canada)
Would that be included in the PPS?
15:42
S…
Speaker 7 (2026-06-08 covid canada)
Yes,
15:44
S…
Speaker 7 (2026-06-08 covid canada)
included in the PPS.
15:46
S…
Speaker 2 (2026-06-08 covid canada)
So
15:59
S…
Speaker 6 (2026-06-08 covid canada)
I think the actions here,
16:00
S…
Speaker 6 (2026-06-08 covid canada)
if we need to confirm on the carton labels as soon as possible,
16:03
S…
Speaker 6 (2026-06-08 covid canada)
because it is going to impact the time.
16:05
S…
Speaker 6 (2026-06-08 covid canada)
And then for the PPS and the BMO,
16:07
S…
Speaker 6 (2026-06-08 covid canada)
we'll need to push it out until the wind shuttle
16:11
S…
Speaker 1 (2026-06-08 covid canada)
actions are
16:15
S…
Speaker 1 (2026-06-08 covid canada)
created for this too.
16:17
S…
Speaker 6 (2026-06-08 covid canada)
Did you start that again or last year?
16:20
S…
Speaker 6 (2026-06-08 covid canada)
Has that started or is that too started after it?
16:23
S…
Speaker 2 (2026-06-08 covid canada)
Actually,
16:24
S…
Speaker 7 (2026-06-08 covid canada)
I have a question regarding this action.
16:27
S…
Speaker 7 (2026-06-08 covid canada)
What is the Winshattel update for Cartoon Labours?
16:30
S…
Speaker 7 (2026-06-08 covid canada)
Is it for adding the Cartoon UDI to
16:35
S…
Speaker 7 (2026-06-08 covid canada)
Winshattel or the other team?
16:38
S…
Speaker 2 (2026-06-08 covid canada)
We're
16:42
S…
Speaker 8 (2026-06-08 covid canada)
not creating a new UDI.
16:44
S…
Speaker 8 (2026-06-08 covid canada)
It's the UDI of the actual kit box.
16:48
S…
Speaker 8 (2026-06-08 covid canada)
being put on the shipper curtain to indicate to the customer
16:53
S…
Speaker 8 (2026-06-08 covid canada)
what is inside the box.
16:54
S…
Speaker 2 (2026-06-08 covid canada)
Then I think the
16:58
S…
Speaker 7 (2026-06-08 covid canada)
windshot update for cutting data is not required and is not necessary.
17:03
S…
Speaker 2 (2026-06-08 covid canada)
So
17:09
S…
Speaker 6 (2026-06-08 covid canada)
this does not require a windshot update but it requires you to create
17:13
S…
Speaker 6 (2026-06-08 covid canada)
the material part numbers?
17:14
S…
Speaker 7 (2026-06-08 covid canada)
Yes.
17:15
S…
Speaker 2 (2026-06-08 covid canada)
Okay
17:21
S…
Speaker 6 (2026-06-08 covid canada)
so if we get that confirmed for
17:25
S…
Speaker 6 (2026-06-08 covid canada)
the end of next this or for our next call anyways we should still be
17:29
S…
Speaker 1 (2026-06-08 covid canada)
on time.
17:36
S…
Speaker 7 (2026-06-08 covid canada)
So I think these two actions can be very big.
17:40
S…
Speaker 7 (2026-06-08 covid canada)
Our three labels can be together.
17:44
S…
Speaker 1 (2026-06-08 covid canada)
Okay,
17:45
S…
Speaker 3 (2026-06-08 covid canada)
perfect.
17:45
S…
Speaker 3 (2026-06-08 covid canada)
Thank you.
17:46
S…
Speaker 1 (2026-06-08 covid canada)
And then we have the
17:51
S…
Speaker 1 (2026-06-08 covid canada)
wind shuttle.
17:52
S…
Speaker 6 (2026-06-08 covid canada)
Once we have all that information,
17:55
S…
Speaker 6 (2026-06-08 covid canada)
what is the lead time on the commercial
18:00
S…
Speaker 6 (2026-06-08 covid canada)
extensions and the price and extensions?
18:05
S…
Speaker 6 (2026-06-08 covid canada)
Once the bomb isn't updated,
18:06
S…
Speaker 1 (2026-06-08 covid canada)
then I thought it's the lead time for that.
18:08
S…
Speaker 2 (2026-06-08 covid canada)
Well,
18:11
S…
Speaker 7 (2026-06-08 covid canada)
I also need to chat with the younger kids.
18:13
S…
Speaker 3 (2026-06-08 covid canada)
Okay.
18:14
S…
Speaker 2 (2026-06-08 covid canada)
And
18:22
S…
Speaker 6 (2026-06-08 covid canada)
just to go back to an action that we had here about the OpenCR review,
18:27
S…
Speaker 1 (2026-06-08 covid canada)
Anna.
18:27
S…
Speaker 1 (2026-06-08 covid canada)
Sorry,
18:29
S…
Speaker 6 (2026-06-08 covid canada)
I tied in with Anna on this.
18:31
S…
Speaker 6 (2026-06-08 covid canada)
This was added last year as a request,
18:34
S…
Speaker 1 (2026-06-08 covid canada)
I think, from the QA team.
18:36
S…
Speaker 1 (2026-06-08 covid canada)
I don't think it's in the CR as an action,
18:39
S…
Speaker 1 (2026-06-08 covid canada)
so...
18:41
S…
Speaker 6 (2026-06-08 covid canada)
Do you want to maintain that in somebody's time with Anna on the dates that are required for
18:45
S…
Speaker 1 (2026-06-08 covid canada)
that?
18:46
S…
Speaker 1 (2026-06-08 covid canada)
Or what are your thoughts on that action?
18:48
S…
Speaker 2 (2026-06-08 covid canada)
I
18:53
S…
Speaker 4 (2026-06-08 covid canada)
don't remember.
18:53
S…
Speaker 5 (2026-06-08 covid canada)
I'm not
18:58
S…
Speaker 8 (2026-06-08 covid canada)
sure either.
19:00
S…
Speaker 8 (2026-06-08 covid canada)
I wasn't sure.
19:04
S…
Speaker 5 (2026-06-08 covid canada)
She said that Ross
19:11
S…
Speaker 5 (2026-06-08 covid canada)
had done the gafferful conferred.
19:15
S…
Speaker 5 (2026-06-08 covid canada)
For COVID oxygen,
19:17
S…
Speaker 5 (2026-06-08 covid canada)
but he had excluded the Canadian skill because it
19:21
S…
Speaker 1 (2026-06-08 covid canada)
was different.
19:21
S…
Speaker 5 (2026-06-08 covid canada)
So I did ask her if we could do a quick review
19:25
S…
Speaker 5 (2026-06-08 covid canada)
of any changes that were related to the Canadian skill.
19:28
S…
Speaker 5 (2026-06-08 covid canada)
So he can do that.
19:31
S…
Speaker 1 (2026-06-08 covid canada)
She can have a look just to see if there's anything significant.
19:33
S…
Speaker 2 (2026-06-08 covid canada)
Okay,
19:53
S…
Speaker 3 (2026-06-08 covid canada)
thank you.
19:54
S…
Speaker 1 (2026-06-08 covid canada)
Any of the TPS?
20:00
S…
Speaker 1 (2026-06-08 covid canada)
Sorry, that's that.
20:02
S…
Speaker 2 (2026-06-08 covid canada)
There's a lot of actions here
20:06
S…
Speaker 2 (2026-06-08 covid canada)
on the Canadian plastic requirements.
20:08
S…
Speaker 2 (2026-06-08 covid canada)
I don't actually know what's involved in those.
20:12
S…
Speaker 2 (2026-06-08 covid canada)
I was hoping somebody could be on the call today to talk through those.
20:16
S…
Speaker 2 (2026-06-08 covid canada)
I checked the change action for a lot of these and they are due the 30th
20:21
S…
Speaker 1 (2026-06-08 covid canada)
of July.
20:22
S…
Speaker 2 (2026-06-08 covid canada)
So I think we'll just keep those as due dates.
20:31
S…
Speaker 1 (2026-06-08 covid canada)
For this,
20:31
S…
Speaker 2 (2026-06-08 covid canada)
it was confirmed and I can mark this is complete now.
20:35
S…
Speaker 2 (2026-06-08 covid canada)
There's no further actions required for the technical file
20:39
S…
Speaker 2 (2026-06-08 covid canada)
for Canada.
20:40
S…
Speaker 1 (2026-06-08 covid canada)
Krishna
20:44
S…
Speaker 2 (2026-06-08 covid canada)
confirmed that last week and there's no House Canada notification form.
20:49
S…
Speaker 2 (2026-06-08 covid canada)
Well, it can be included as part of their annual review,
20:51
S…
Speaker 2 (2026-06-08 covid canada)
so there's no regulatory action holding these actions
20:56
S…
Speaker 1 (2026-06-08 covid canada)
up.
20:56
S…
Speaker 2 (2026-06-08 covid canada)
So that's marked as complete as well.
21:00
S…
Speaker 2 (2026-06-08 covid canada)
I'm talking with Shane after this on the labels.
21:03
S…
Speaker 2 (2026-06-08 covid canada)
We had the due date for the 15th.
21:04
S…
Speaker 2 (2026-06-08 covid canada)
I think the CEO is still on pendant.
21:06
S…
Speaker 2 (2026-06-08 covid canada)
So I'm talking with him after this.
21:08
S…
Speaker 2 (2026-06-08 covid canada)
It was just that we had an action as well for the LN transfer plan.
21:12
S…
Speaker 2 (2026-06-08 covid canada)
Are we still doing LN transfer plans?
21:15
S…
Speaker 1 (2026-06-08 covid canada)
Or I know
21:20
S…
Speaker 2 (2026-06-08 covid canada)
for the,
21:21
S…
Speaker 2 (2026-06-08 covid canada)
why don't we close out some of the IVDR ones?
21:26
S…
Speaker 3 (2026-06-08 covid canada)
Let's get them all closed out.
21:28
S…
Speaker 3 (2026-06-08 covid canada)
I don't know if this one,
21:31
S…
Speaker 3 (2026-06-08 covid canada)
I'm not sure if the status of this one,
21:32
S…
Speaker 3 (2026-06-08 covid canada)
but we should close it out and then any actions relevant
21:37
S…
Speaker 3 (2026-06-08 covid canada)
to Canada, we should take through this.
21:39
S…
Speaker 3 (2026-06-08 covid canada)
But I guess we need to at least have an action in there
21:43
S…
Speaker 3 (2026-06-08 covid canada)
to make sure that we don't close out the CR without the airline
21:47
S…
Speaker 3 (2026-06-08 covid canada)
transfer plan being updated.
21:49
S…
Speaker 1 (2026-06-08 covid canada)
And
21:55
S…
Speaker 2 (2026-06-08 covid canada)
do we know where the ownership of the airline transfer plan lies?
22:04
S…
Speaker 2 (2026-06-08 covid canada)
I think the
22:15
S…
Speaker 1 (2026-06-08 covid canada)
QA
22:22
S…
Speaker 3 (2026-06-08 covid canada)
team are leading this.
22:23
S…
Speaker 1 (2026-06-08 covid canada)
I
22:32
S…
Speaker 2 (2026-06-08 covid canada)
can help
22:38
S…
Speaker 1 (2026-06-08 covid canada)
with it.
22:38
S…
Speaker 1 (2026-06-08 covid canada)
Some
22:47
S…
Speaker 4 (2026-06-08 covid canada)
of the actions are set on going in the transfer plan.
22:52
S…
Speaker 3 (2026-06-08 covid canada)
But I think the intention,
22:53
S…
Speaker 3 (2026-06-08 covid canada)
surely, is that we're going to close the actions and point out to the
22:57
S…
Speaker 3 (2026-06-08 covid canada)
implementation change requests for those.
23:00
S…
Speaker 4 (2026-06-08 covid canada)
Right.
23:01
S…
Speaker 1 (2026-06-08 covid canada)
But
23:06
S…
Speaker 2 (2026-06-08 covid canada)
this isn't going to have an implementation change request,
23:08
S…
Speaker 2 (2026-06-08 covid canada)
though. Well, it does have a LN transfer one.
23:11
S…
Speaker 2 (2026-06-08 covid canada)
It's just not the same as the IVGO one.
23:13
S…
Speaker 2 (2026-06-08 covid canada)
There's a different format for this one.
23:15
S…
Speaker 1 (2026-06-08 covid canada)
But maybe that's not the same.
23:18
S…
Speaker 2 (2026-06-08 covid canada)
But it just points to the CR.
23:21
S…
Speaker 1 (2026-06-08 covid canada)
It should have all the same actions to implement in Canada
23:25
S…
Speaker 1 (2026-06-08 covid canada)
though, or whatever actions are needed.
23:27
S…
Speaker 1 (2026-06-08 covid canada)
Yeah, yeah,
23:28
S…
Speaker 1 (2026-06-08 covid canada)
yeah, yeah,
23:29
S…
Speaker 2 (2026-06-08 covid canada)
a bit more detailed,
23:31
S…
Speaker 1 (2026-06-08 covid canada)
but yeah.
23:31
S…
Speaker 1 (2026-06-08 covid canada)
Okay,
23:38
S…
Speaker 2 (2026-06-08 covid canada)
so I think it's got the action to where we just need to follow up after today's call,
23:42
S…
Speaker 2 (2026-06-08 covid canada)
unless we have an update on
23:46
S…
Speaker 2 (2026-06-08 covid canada)
Shane and Mary's actions.
23:50
S…
Speaker 2 (2026-06-08 covid canada)
I think he's working on,
23:51
S…
Speaker 2 (2026-06-08 covid canada)
Shane's working on their complaint on an update.
23:54
S…
Speaker 2 (2026-06-08 covid canada)
We've put in the 30th of July as a
23:59
S…
Speaker 2 (2026-06-08 covid canada)
due date, so I know the text script needs to be updated or created for
24:03
S…
Speaker 2 (2026-06-08 covid canada)
COVID -19 and Southwest.
24:04
S…
Speaker 1 (2026-06-08 covid canada)
But there should be one
24:08
S…
Speaker 1 (2026-06-08 covid canada)
there from Vienna.
24:09
S…
Speaker 1 (2026-06-08 covid canada)
Yeah,
24:10
S…
Speaker 2 (2026-06-08 covid canada)
I think he's in the one from Vienna,
24:12
S…
Speaker 1 (2026-06-08 covid canada)
yeah.
24:12
S…
Speaker 2 (2026-06-08 covid canada)
Okay,
24:15
S…
Speaker 2 (2026-06-08 covid canada)
and then I think it's going to be time with Mary as well about the RGD actions
24:19
S…
Speaker 2 (2026-06-08 covid canada)
here.
24:19
S…
Speaker 1 (2026-06-08 covid canada)
I know,
24:20
S…
Speaker 2 (2026-06-08 covid canada)
so when you get an update on the,
24:25
S…
Speaker 2 (2026-06-08 covid canada)
for the QMS updates.
24:27
S…
Speaker 2 (2026-06-08 covid canada)
Maybe we need to change the due date on these because we're
24:31
S…
Speaker 2 (2026-06-08 covid canada)
no longer going to be waiting for the registry approval.
24:34
S…
Speaker 4 (2026-06-08 covid canada)
Steve is working on the line 46
24:38
S…
Speaker 4 (2026-06-08 covid canada)
and we're in the support and 47 we have a CO pulled.
24:43
S…
Speaker 4 (2026-06-08 covid canada)
Alan has a CO pulled.
24:44
S…
Speaker 1 (2026-06-08 covid canada)
Okay,
24:47
S…
Speaker 1 (2026-06-08 covid canada)
great.
24:47
S…
Speaker 1 (2026-06-08 covid canada)
Okay,
24:51
S…
Speaker 1 (2026-06-08 covid canada)
and
24:57
S…
Speaker 1 (2026-06-08 covid canada)
then
24:59
S…
Speaker 2 (2026-06-08 covid canada)
To the question last week,
25:01
S…
Speaker 2 (2026-06-08 covid canada)
it was discussing lots of people at marketing that we can tie in and marketing a current review
25:06
S…
Speaker 2 (2026-06-08 covid canada)
and to make sure there's no promotional material updates required.
25:09
S…
Speaker 2 (2026-06-08 covid canada)
I followed up with those so I can add the Judith to those once we hear back
25:13
S…
Speaker 2 (2026-06-08 covid canada)
from marketing.
25:14
S…
Speaker 2 (2026-06-08 covid canada)
So,
25:16
S…
Speaker 2 (2026-06-08 covid canada)
Anya, I know you had a question last week about the demand.
25:19
S…
Speaker 2 (2026-06-08 covid canada)
There is no demand currently or forecast for this code,
25:22
S…
Speaker 2 (2026-06-08 covid canada)
but the lead time was 60 days.
25:28
S…
Speaker 2 (2026-06-08 covid canada)
I've queried that with Conor,
25:29
S…
Speaker 2 (2026-06-08 covid canada)
because he's on holidays,
25:31
S…
Speaker 2 (2026-06-08 covid canada)
because the lead time for the EMA code is 30 days,
25:33
S…
Speaker 2 (2026-06-08 covid canada)
and I'm not quite sure the lead time for the EMA code would be 60.
25:36
S…
Speaker 2 (2026-06-08 covid canada)
So we're not working on
25:40
S…
Speaker 2 (2026-06-08 covid canada)
an incorrect information.
25:42
S…
Speaker 2 (2026-06-08 covid canada)
I'm asking to follow up and confirm that.
25:45
S…
Speaker 1 (2026-06-08 covid canada)
Sorry,
25:47
S…
Speaker 1 (2026-06-08 covid canada)
Gillian.
25:47
S…
Speaker 4 (2026-06-08 covid canada)
What's number 55 is my name for?
25:50
S…
Speaker 1 (2026-06-08 covid canada)
I
25:55
S…
Speaker 2 (2026-06-08 covid canada)
think there's a bad action in the CR.
25:59
S…
Speaker 2 (2026-06-08 covid canada)
It was to notify...
26:02
S…
Speaker 2 (2026-06-08 covid canada)
or the IL of the LN transfer.
26:04
S…
Speaker 2 (2026-06-08 covid canada)
I can go back and check who's assigned that action,
26:07
S…
Speaker 2 (2026-06-08 covid canada)
but that's what that action is.
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