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2
Canada Releases Final Amendments To Patented Medicines Pricing Regulations; In Force July 1, 2020
There are a number of notable changes to the regulations relative to the draft version published December 2, 2017.
Canada
26 Sep 2019
3
Countdown To July 1, 2020: Getting Ready For The New Patented Medicines Pricing Regime
The amended Regulations will come into force on July 1, 2020.
Canada
26 Sep 2019
4
The Experimental Use Exception Under The Recently Amended Canadian Patent Act
Canada recently introduced new legislation (The Budget Implementation Act, 2018, No. 2) which brought about several changes to the Patent Act affecting the scope of protection available under Canadian patents.
Canada
26 Sep 2019
5
New Details On The Government Of Canada's IP Strategy
In the global knowledge economy of the 21st century, governments are becoming aware of the importance of intellectual propertyand are putting in place strategies to encourage innovative businesses to invest in IP.
Canada
26 Sep 2019
7
Regulations Will Require Hospitals To Report Serious Adverse Drug Reactions And Medical Device Incidents
On June 10, 2019, the Regulations Amending the Food and Drug Regulations (Serious Adverse Drug Reaction Reporting – Hospitals)and Regulations Amending the Medical Devices Regulations
Canada
5 Aug 2019
8
New Canadian Patent Rules Will Be In Force October 30, 2019
On July 10, 2019, the government of Canada published the final version of the new Patent Rules, which will come into force October 30, 2019.
Canada
5 Aug 2019
9
Federal Court Of Appeal Dismisses First PMNOC Interlocutory Appeal Granted Leave
Most interlocutory decisions under the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) are made by prothonotaries of the Federal Court (FC).
Canada
5 Aug 2019
10
Court Strikes Novo Nordisk's Judicial Review Application Of Minister's Acceptance Of Teva's Liraglutide ANDS
The Federal Court struck Novo Nordisk's judicial review application challenging the decision of the Minister of Health to accept for review an Abbreviated New Drug Submission (ANDS)
Canada
5 Aug 2019
11
PMPRB Steering Committee On Modernization Of Price Review Process Guidelines Releases Final Report
On July 2, 2019, the PMPRB Steering Committee on the Modernization of Price Review Process Guidelines released its final report summarizing
Canada
5 Aug 2019
12
Biosimilars No Longer Reviewed By CADTH
The Canadian Agency for Drugs and Technologies in Health (CADTH) released Issue 8 of its Pharmaceutical Reviews Update announcing updates
Canada
5 Aug 2019
13
Guidance Updates
Health Canada released a revised Guidance Document: Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs on June 28, 2019
Canada
5 Aug 2019
14
Health Canada, TPD And BGTD Annual Reports Released
On June 27, 2019, Health Canada published Drug and medical device highlights 2018: Helping you maintain and improve your health, an annual highlights report for 2018.
Canada
5 Aug 2019
15
Health Canada Opens Consultation On Draft Guidance Document Distinguishing Between Promotional And Non-Promotional Activities For Health Products
On July 5, 2019, Health Canada announced a consultation on its new draft guidance: The Distinction Between Promotional and Non-promotional Messages and Activities for Health Products.
Canada
5 Aug 2019
16
Bill C-97 Receives Royal Assent, Advanced Therapeutic Products Consultation Opened
On June 21, 2019, Bill C-97 received Royal Assent. Bill C-97 includes amendments to the Food and Drugs Act, including a new framework for "Advanced Therapeutic Products"
Canada
5 Aug 2019
17
Federal Court Of Appeal Requires PMPRB To Re-Determine Whether Patent ‘Pertains To' Galderma's DIFFERIN
On June 28, 2019, the Federal Court of Appeal granted the appeal of the Patented Medicine Prices Review Board (PMPRB or Board) and returned to the Board the matter of whether the invention of the 237
Canada
5 Aug 2019
18
PC v. PC. Pampered Chef Succeeds In Trademark Infringement Battle: Smart & Biggar Prevails At Trial On Behalf Of Pampered Chef
On July 22, 2019, the Federal Court issued its decision in Loblaws Inc v Columbia Insurance Company, 2019 FC 961. Pampered Chef, a Berkshire Hathaway company and a world-leader
Canada
30 Jul 2019
19
Pre-Amended PMNOC Regulations: Court Decisions On The Merits (Polymorph, Salt, Formulation Patents)
There have been two Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) decisions on the merits so far in 2019 and a pair of appeal decisions
Canada
16 Jul 2019
20
Biosimilars: Market Access, Naming, Studying Usage
As of June 30, Health Canada had approved 16 biosimilars, based on 11 comparator products (3 in 2019).
Canada
16 Jul 2019
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