PMPRB guidelines scoping paper : high level overview of potential new framework : CGI consultation phase. : H82-30/2017E-PDF

"This scoping paper is intended to be read in conjunction with proposed amendments to the Patented Medicines Regulations (“Regulations”), and accompanying Regulatory Impact Analysis Statement (RIAS), which were pre-published in the December 2nd, 2017 issue of the Canada Gazette, Part I. Its purpose is to provide stakeholders and interested members of the public with an outline of the PMPRB’s preliminary thoughts on how best to operationalize the proposed changes to the Regulations, through non-binding Guidelines as contemplated by s.96 of the Patent Act, within the context of the existing and proposed legislation and the PMPRB’s ongoing efforts at reform"--p. 3 Introd.

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publications.gc.ca/pub?id=9.849043&sl=1

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