WHAT CHANGED
Under the old process a foreign manufacturer could be assessed once and referenced by every importer who used it. That mechanism no longer exists. Each importer now assembles and submits a full GMP evidence package for each foreign site, on each application, amendment and renewal. Where several importers share a manufacturer, each submits separately. The manufacturer has no way to do it for them.
WHERE THIS BITES
01
Guidance that has not caught up
Health Canada’s site licence application form and site licensing guidance still reference the old process as acceptable evidence. Anyone working from the published documents is working from something superseded.
02
Relationships that were never documented
Importers who relied on a manufacturer’s reference number often have no GMP evidence of their own, no quality agreement, and no established route to request either.
03
Repeated submissions
A manufacturer supplying several Canadian importers now fields the same document request from each of them, with no shared file to point at.
04
Timeline exposure
GMP evidence is now reviewed inside the site licence pathway rather than ahead of it, which changes when a gap is discovered and how much runway is left to close it.
WHAT WE DO
Assemble the file, not just the application.
Review of existing foreign site documentation and identification of what is missing.
GMP evidence package assembly to the standard required for site licence submission.
Quality agreement drafting between importer and foreign site.
Supplier risk assessment and manufacturer qualification.
Site licence application, amendment and renewal support.
Coordination with the foreign site where language, confidentiality or reluctance is an obstacle.
Audit readiness review.
WHO THIS IS FOR
Canadian importers
Importers who now carry evidence obligations they previously delegated to a manufacturer’s reference number.
Foreign manufacturers
Sites in the US, Europe and Asia that supply Canada and need their documentation to survive a Canadian importer’s submission.
WHY KOMPETE
Kompete is a registered Trading Partner with Health Canada’s NNHPD under company code 79873. We work on both the importer and the manufacturer side of foreign site qualification.
Bring us the foreign sites, the importer of record and the submission you are working toward. We will tell you what evidence exists, what is missing and how the file gets assembled.