Publication
Horizon Scanning: Investigations and Enforcement
In this horizon scan, we focus on key developments affecting companies operating in the UK, including in light of the recent change in UK government.
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
Publication
In this horizon scan, we focus on key developments affecting companies operating in the UK, including in light of the recent change in UK government.
Publication
As you begin planning for the upcoming financial year, it is likely that legal operations projects are on your radar. However, securing the necessary budget can be challenging. Our roundtable on October 1, ‘Preparing for FY2025 - Building a compelling business case’, will help you create compelling business cases for your legal initiatives.
Publication
On 3 September 2024, the ECJ delivered its judgment in Illumina’s appeal against the General Court’s (GC) judgment confirming the European Commission’s (EC) powers to review concentrations under the EU Merger Regulation (EUMR) in circumstances where no Member State has jurisdiction under national law.
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