PM(NOC) guidance document updated to address cross-referenced drug submissions

On April 2, 2012, Health Canada issued an updated guidance document on the Patented Medicines (Notice of Compliance) Regulations. In particular, section 3.4.1 of the guidance document has been updated to clarify the triggering provisions. Specifically, administrative drug submissions (e.g. for a name change) will not trigger any obligations under the PM(NOC) Regulations. In addition, a manufacturer who cross-references its abbreviated drug submission to another abbreviated drug submission will not re-trigger section 5 of the PM(NOC) Regulations.

The guidance document is effective April 16, 2012 and does not apply to previously submitted cross-referenced drug submissions.  A copy of the updated guidance document can be found here.