In light of the evolving global trade landscape, we felt it would be appropriate to add an addendum to our FYI policy to accommodate timely insertion of the claims, “Product of Canada” or “Made in Canada”, in existing APS.        

For existing APS within their approval period, the PAAB will accept the addition of a sticker / callout, “Product of Canada” or “Made in Canada”, as an FYI (please see FYI email requirements at the end of this document) provided the conditions below are met (i.e., a full re-review will not be required).

For the claim “Product of Canada”

The FYI email to PAAB must include a letter from the medical/regulatory/compliance or equivalent department confirming the following:

1. the last substantial transformation of the good occurred in Canada (i.e., processing, assembly, production); and
2. all or virtually all (at least 98%) of the total direct costs of producing or manufacturing the good have been incurred in Canada

Claim positioning in APS:

Note that, in APS containing multiple products, it must be clear which product(s) the claim pertains to. It should also be clear that the claim pertains to the product (rather than implying some broader meaning). The claim must not be positioned in a manner which suggests clinical or comparative clinical significance.

Principles ‘a’ and ‘b’ above are adapted from the Competition Bureau’s corresponding Enforcement Guideline.

 

For the claim “Made in Canada”

The FYI email to PAAB must include a letter from the medical/regulatory/compliance or equivalent department confirming the following: 

1. the last substantial transformation of the good occurred in Canada (i.e., processing, assembly, production);
2. at least 51% of the total direct costs of producing or manufacturing the good have been incurred in Canada; and
3. the accompanying qualifying statement (see below) is accurate

Qualifying Statement (if imported materials are included):

The claim must be accompanied by an appropriate qualifying statement indicating that the product contains imported content (e.g., "Made in Canada with imported parts" or "Made in Canada with domestic and imported parts"). This could also include more specific information such as "Made in Canada with 60% Canadian content and 40% imported content".

Claim positioning in APS:

Note that, in APS containing multiple products, it must be clear which product(s) the claim pertains to. It should also be clear that the claim pertains to the product (rather than implying some broader meaning). The claim must not be positioned in a manner which suggests clinical or comparative clinical significance.

Principles ‘a’, ‘b’, and ‘c’ above are adapted from the Competition Bureau’s corresponding Enforcement Guideline.

Other claims

Other claims would be reviewed on a case-by-case basis under the standard preclearance process.

How about new APS?

The requirements/standards outlined herein apply equally to new APS.

Standard FYI Submission Instructions

FYIs are informative emails sent to review@paab.ca to make the PAAB aware of post-approval changes to an approved APS. The client is responsible for ensuring that the TMA has not changed since initial approval of the piece. To provide an FYI to the PAAB regarding the addition of a “Product of Canada” or “Made in Canada” sticker/callout, please email review@paab.ca. Please include the following in your FYI email:

• The reason for the FYI
• The final copydecks and layouts which highlight the changes
• Previously approved eFile number
• Your telephone contact information

Your email will be processed and filed as an FYI and the email and your final APS documents will be uploaded to the originally approved file. You will be notified when your FYI has been filed. For more information on FYIs, please visit section 4.2 of the Guidance on Submission Process and Format Requirements.