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Hi folks,
We are a US company using a Canadian CDMO to manufacture an investigational drug for use in a Phase I clinical trial in the US. We have received the approval for the IND. Does Health Canada have any particular requirements to export/ship the investigation use drug out of Canada into the US (i.e. export certificate)? Does it make a difference whether this CDMO holds an Establishment Licence with Health Canada or not?
Thanks in adavnce!