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Ontario To Require Public Disclosure Of Industry Payments To Health Care Professionals
On September 27, 2017, the Government of Ontario tabled a bill to enact the Health Sector Payment Transparency Act, 2017, (the "Act")...
Canada
6 Oct 2017
2
Supreme Court Of Canada Dismisses Application For Leave To Appeal Patent Listing Decision
The Supreme Court of Canada has dismissed Gilead's application for leave to appeal the decision of the Federal Court of Appeal, involving the eligibility of a patent for listing on the Patent Register in relation to a combination drug product.
Canada
18 Apr 2013
3
No More Exemptions For Unlicensed Natural Health Products
Last month marked the end of the "Natural Health Products (Unprocessed Product Licence Applications) Regulations".
Canada
14 Mar 2013
4
Provinces And Territories Take First Step On A Pan-Canadian Approach To Management Of Drug Costs
On January 18, 2013, the Canadian provinces and territories (with the exception of Quebec) announced a joint initiative designed to achieve significant cost savings for publicly funded drug plans.
Canada
25 Jan 2013
5
Proposed Prescription Drug List Available For Public Consultation
The List sets out drugs and classes of drugs that are divided based on medicinal ingredients for human and veterinary use.
Canada
15 Jan 2013
6
Nobody’s Perfect - Canadian Court Addresses The Standard When Correcting Clerical Errors
In the recent case of "Repligen Corporation v. Canada (Attorney General)" (2012 FC 931), the Federal Court granted a second application for judicial review of a decision made by the Commissioner of Patents.
Canada
12 Dec 2012
7
Crossing Borders: The Inclusion Of Foreign Drug Reviews In Canadian Data Packages
In October 2011, Health Canada implemented a pilot project for the use of foreign review assessment information when evaluating health products seeking market authorization in Canada.
Canada
30 Oct 2012
8
"Keeping Up With The Joneses": Proposed Amendment To The Food And Drug Regulations Seeks To Extend Good Manufacturing Practices Requirements To All Active Ingredients
An amendment to the Food and Drug Regulations has been proposed that would extend the good manufacturing practices (GMP) requirements for drugs to all active ingredients (AI); extend drug establishment licensing requirements to those carrying out various activities involving AI; and create a new record-keeping requirement to facilitate the ability to trace AI from the original fabricator to the dosage-form drug manufacturer.
Canada
14 Oct 2012
9
Health Canada Issues Updated Compliance And Enforcement Guidelines For Medical Devices
On August 10, 2012, Health Canada released an updated Guidance on Medical Device Compliance and Enforcement (GUI-0073).
Canada
13 Sep 2012
10
DIP Working Group Recommends That PMPRB Permanently Adopt The DIP Methodology
On May 16, 2012, a Report setting out the follow-up recommendations of the DIP Working Group on the pilot implementation of the DIP Methodology was released by the PMPRB.
Canada
13 Jun 2012
11
PMPRB Seeks More Efficient Use Of Its Resources
The Patented Medicine Prices Review Board is seeking stakeholder comments on proposed changes to its Compendium of Policies, Guidelines and Procedures related to thresholds for opening an investigation and offsetting de minimus excess revenues.
Canada
2 May 2012
12
Drugs Made Available Under The Special Access Programme May Still Be Eligible For Data Protection
On April 10, 2012, the Federal Court of Appeal issued its decision in Teva Canada Limited v. Canada (Health), confirming that drugs made available in Canada pursuant to the Special Access Programme (SAP) are not considered to be "previously approved" under subsection C.08.004.1(1) of the Food and Drug Regulations and therefore remain eligible for data protection.
Canada
26 Apr 2012
13
What's Old CAN Be New Again: Thalidomide Is Considered "Innovative"
The Federal Court of Canada has recently held that a drug previously approved in Canada, but withdrawn for safety reasons, could later qualify as an "innovative drug".
Canada
19 Mar 2012
14
Ontario Regulations Prohibiting The Listing Of Private Label Drug Products Upheld
In December 2011, the Court of Appeal for Ontario reversed the Divisional Court decision in Shoppers Drug Mart Inc. v. Ontario (Health and Long-Term Care) and ruled that certain provisions of the Regulations made under the Ontario Drug Benefits Act and the Drug Interchangeability and Dispensing Fee Act (collectively, the Regulations) preventing the listing of "private label" generic drug products on the Ontario Drug Benefit Formulary were within the power of the Minister under the parent statute
Canada
13 Mar 2012
15
What’s In A Name?
In December 2011, the US Food and Drug Administration (FDA) reported that at least one serious injury occurred when a topical wart remover, Durasal (salicylic acid 26%), was dispensed to a patient following eye surgery instead of a topical corticosteroid, Durezol.
Canada
28 Feb 2012
16
Canada Strengthening Its IP Regime
As with previous years, Canada has been placed on the U.S. 2011 Priority Watch List of countries for which there are concerns regarding the protection and enforcement of intellectual property rights.
Canada
1 Nov 2011
17
An Eyesore No More – Proposed Legislation To Classify Cosmetic Contact Lenses As Class II Medical Devices
On October 3, Bill C-313, An Act to Amend the Food and Drugs Act (Non-Corrective Cosmetic Contact Lenses) was introduced in Parliament.
Canada
31 Oct 2011
18
Administrative Drug Submissions To Be Excluded From The PM(NOC) Regulations?
Health Canada recently released proposed revisions to its Patented Medicines (Notice of Compliance) Regulations guidance document that, if implemented, will exclude certain administrative drug submissions (e.g., where a licensee cross-references a licensor's drug submission) from the scope of section 5 of the PM(NOC) Regulations. Section 5 of the Regulations sets out requirements that a second person (typically a generic manufacturer) must comply with in submissions seeking a NOC for a drug that
Canada
17 Oct 2011
19
Canadian Federal Court Of Appeal Defuses An "Atomic Bomb" Of Patent Law And Stops Inequitable Conduct At The Border
In late July, the Canadian Federal Court of Appeal released its decision in Corlac Inc. et al. v. Weatherford Canada Limited et al in which the Court clarified the grounds upon which an issued patent can be invalidated.
Canada
24 Aug 2011
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