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Reply to: COVID Cross Border Direct to PatientApril 28, 2020 at 7:12 pm
Hi Amy, I am aware of a patient from the UK (enrolled in a clinical trial in the UK) but is “stuck” in Canada. The protocol is not approved in Canada. The regulatory authorities in both countries are being consulted on this and they are working on an exception to import the drug into Canada for the patient. It has not been finalized yet, but I would recommend reaching out to both reg authorities and involving the Investigator responsible for the patient. You will most likely be required to do a risk assessment highlighting patient safety. Hope this helps!