The Office of Patented Medicines and Liaison (OPML) within Health Canada released proposed revisions to its PM(NOC) Guidance Document relating to administrative new drug submissions and administrative abbreviated new drug submissions.
The preamble sets out the reason for the proposed changes:
While compliance with section 5 is appropriate for most new drug submissions approved on the basis of a direct or indirect comparison or reference to an innovative drug, stakeholders have questioned whether the current requirement is redundant and, therefore, unnecessary under the PM(NOC) Regulations: namely, that a drug manufacturer who submits an administrative drug submission pursuant to a licensing agreement must re-address patents listed on the Patent Register in respect of the innovative drug prior to receiving an NOC.
Further, from an administrative perspective, given the extent of administrative drug submissions recently submitted to the TPD, there has been an increase in the documentation submitted to the OPML which has burdened resources and affected the overall processing of such submissions.
Interested parties have 60 days to provide comments to the Office of Patented Medicines and Liaison.
Update: Jonathan Mesiano-Crookston of (IP) Law in Canada posted an update on these proposed revisions as well.