No. Since this drug would not be sold by the packager/labeller, this establishment would not be
considered as an importer under Division 1A of the Food and Drug Regulations and thus, this site would not
have to be listed on the licence of the packager/labeller. However, the packager/labeller would still need to
fulfil all the requirements outlined under Section 4.0 of GUI-0067 that is: obtaining evidence of GMP
compliance of the foreign site and supplying the proper information to Health Canada within the prescribed
time frame.
