United Nations Climate Change
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The Ontario Ministry of Health and Long-Term Care recently updated the Ontario Guidelines for Drug Submission and Evaluation (“Guidelines”). These Guidelines govern drug submissions for inclusion on the Ontario Drug Benefit Formulary or for listing as an interchangeable drug.
Despite various amendments to the regulations under the Ontario Drug Benefit Act and the Drug Interchangeability and Dispensing Fee Act (“Regulations”), this is the first time the Guidelines have been updated since 2000.
The Guidelines provide practical information and guidance to manufacturers making drug submissions to the province of Ontario in order to have drug products listed on the Ontario Drug Benefit Formulary or as interchangeable products under the Drug Interchangeability and Dispensing Fee Act.
This update to the Guidelines consolidates changes made to the Regulations as well as related changes to submission policy. The Guidelines do not address recent proposed changes to the Regulations intended to streamline generic interchangeability (found here).
The Guidelines can be found at the link below and include an executive summary of these changes.
Highlights of changes to the Regulations since 2000 include:
Highlights of changes to submission policy since 2000 include:
The Guidelines can be found here: Ontario Guidelines for Drug Submission and Evaluation
IMO 2020 is almost upon us. Readers are well aware of the impending switch to 0.5 percent fuel mandated by Annex VI of MARPOL which will cause an anticipated drop in HSFO demand, the potential hazards of new untested LSFO blends, the concerns around scrubber operations, the debate over open loop versus closed loop, and the myriad of other risks associated with the impending regulatory change.