Health Canada Releases Final Guidance Document on NOC Regulations

On December 13, 2007, the Therapeutics Products Directorate (TPD) of Health Canada released its final publication of the Guidance Document: Patented Medicines (Notice of Compliance) Regulations (Guidance). The Guidance outlines the roles and responsibilities of first persons (brand manufacturers), second persons (generic manufacturers) and the TPD's Offices of Patented Medicines and Liaison (OPML), under the Patented Medicines (Notice of Compliance) Regulations. The Guidance does not apply to patents on patent lists submitted prior to June 17, 2006. However, the Guidance applies to all second person generic submissions, including those filed prior to the date that the amendments came into force, namely, October 5, 2006. For a further discussion of the Guidance visit: Health Canada Releases Final Guidance Document on NOC Regulations Summary by: Nick Wong