Summary

On August 17, 2011, the Office of Patented Medicines and Liaison released proposed revisions to Health Canada’s Guidance Document: Patented Medicines (Notice of Compliance) Regulations (“Guidance Document”). The Guidance Document on the PM(NOC) Regulations (“Regulations”) was initially published in 2000 and last revised in November 2010.

Key Revision:

The proposed revisions to the Guidance Document exclude certain types of Administrative New Drug Submissions and Administrative Abbreviated New Drug Submissions from the ambit of the Regulations.  Under the proposed revisions, only the originating NDS or originating ANDS will trigger the application of section 5 of the Regulations and not any subsequent related administrative drug submissions. Administrative drug submissions are typically filed in the context of corporate restructuring and licensing arrangements, including private label drug products. 

Any future supplemental drug submissions (for example, for a change in formulation, dosage form or change in use of the medicinal ingredient) that directly or indirectly compares the drug with or makes reference to a first person’s drug will still be required to address each patent on the Patent Register in respect of the first person’s drug listed prior to the date of filing of the respective supplement drug submission. This requirement is applicable to any second person regardless of whether the marketed drug product received a Notice of Compliance by way of an originating or administrative drug submission.

Stakeholder Feedback:

Comments should be provided to Health Canada within 60 days of Health Canada’s notice, October 18, 2011.  Comments provided during the consultation period may be disclosed publicly. Comments should be directed to:

Office of Patented Medicines and Liaison

Therapeutic Products Directorate

Health Canada

Finance Building

101 Tunney's Pasture Driveway

Ottawa, Ontario

K1A 0K9

Link:

Link to Health Canada’s Notice - Release of the Proposed Revisions to the Guidance Document: Patented Medicines (Notice of Compliance) Regulations:

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce-annonce/notice_pmnoc_avis_mbac-eng.php