Hello,
I am preparing a CTA for Canada and the drug is being imported from Belgium. Per Mutual Recognition Agreement(MRA) between Canada and EU member states, Belgium is on the list of the EU member states so is there a requirement of a legal entity for importation or the drug can be imported in to the site? Also, can I list individual site as authorized importer?
Is Canadian Lot Release a requirement for all drugs imported for a clinical Trial? Will it be required in this scenario?
Thank you,
Best Regards,
Nikita
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Nikita Kathpal, MS
Regulatory Officer II, USA & Canada
Pharm-Olam International
450 N. Sam Houston Parkway, E. Suite 250
Houston, TX 77060
Email:
nikita.kathpal@pharm-olam.comDirect line: +1 713-559-7964
Main: +1 713-559-7900 Ext. 11164
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