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PMPRB published SUBSTANTIALLY DIFFERENT proposed Reg changes

On December 31, 2005, the Patented Medicine Prices Review Board published on the Canada Gazette its "updated" proposed amendments to the Patented Medicines Regulations. These updated proposed amendments are substantially different than the originally proposed amendments published in January 2005 to which stakeholders had to send their comments by April 2005. The table below presents the key differences between the originally published amendments and the updated proposed amendments:


Proposed amendments
January 05
Updated proposed amendments
Decembre 05

Notification of proposed price filed 60 days prior to first sale

Notification of price by filing Form 1 one (1) day after the first sale

Notification of a proposed price increase 120 days prior to the effective day of increase


Notify PMPRB as soon as possible after a note is sent to any class of customers in any province about the price increase


Details on the calculation of net price and net revenues


A column with explanatory notes (identifying the type of each transaction) is to be added to the Form 2


Product monograph/draft monograph submitted automatically


A product monograph should be filed along with the Form 1 within the earlier of 7 days after NOC or 1 day after first sale in Canada or if no NOC, draft monograph to be submitted


Recognition of electronic signatures


No mentioning of this


Other minor changes


Form 1 due the earlier of seven (7) days after receipt of NOC [currently this is 30 days] or one (1) day after the first sale [currently this is 60 days] Form 1 should include patent application number and date of filing of patent application [ currently this include patent number and date patent granted]


Other minor changes


Form 2 due one (1) day after the first sale [currently this includes the first 30 days of sale] and 15 days after the end of each reporting period [currently this is due 30 days after the end of each reporting period]



Interested stakeholders can send their comments on the updated proposed amendments by January 30, 2006. The comments shoud cite Canada Gazette Part I and the date of the publication of the updated proposed amendments (Dec 31, 2005) and can be addressed to Sylvie Dupont at sdupont@pmprb-cepmb.gc.ca. The Board is hoping that these Regulations will be in force in Spring 2006. Of course, this is subject to the response received to Gazette Part I.

If you have any questions on the above, please don't hesitate to contact Lama Abi Khaled at 599-0711 Ext. 236. For more information about the updated proposed amendments, please see the following link: http://canadagazette.gc.ca/partI/2005/20051231/html/regle7-e.html

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