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The Generic Submissions Under Review (GSUR) list
(previously reported) is a list of Abbreviated
New Drug Submissions (generic submissions) that were accepted into
review on or after October 1, 2018 and is intended to be updated on
a monthly basis. The list currently includes the medicinal
ingredient(s), therapeutic area and number of submissions under
review. On January 7, 2019, Health Canada published a Notice soliciting feedback on possible impacts
and uses to stakeholders if the GSUR list is updated to include
sponsor names (i.e., the company that filed the generic
submission). As previously reported, sponsors are included in
the Submissions Under Review List for new drug
submissions (which includes biosimilars) accepted into review on or
after October 1, 2018. Stakeholder feedback should be submitted by
email to Health Canada by February 8, 2019.
The preceding is intended as a timely update on Canadian
intellectual property and technology law. The content is
informational only and does not constitute legal or professional
advice. To obtain such advice, please communicate with our offices
directly.