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Smart & Biggar | Canada | 7 Jun 2023
CADTH consultation on time-limited reimbursement initiative and IMC report on what Canada can learn from Europe
The Canadian Agency for Drugs and Technologies in Health has released a consultation document for a proposed process for time-limited reimbursement recommendations. The initiative aims to help ensure timely access to promising new therapies and would better align with conditional regulatory approval. Meanwhile, Innovative Medicines Canada has released a report that outlines various......
Smart & Biggar | Canada | 31 May 2023
Health Canada opens consultation on proposed application of definition of Canadian reference product based on dormant status
A generic drug manufacturer can file an abbreviated new drug submission based on a comparison to a Canadian reference product. Health Canada recently opened for consultation a proposed application of the definition of "Canadian reference product" under C.08.001.1(b) of the Food and Drug Regulations.
Lexology PRO | Israel | 10 May 2023
Israel scores €2.1 million settlement over delivery platform exclusivity
Food delivery platform Wolt has settled with Israel’s Competition Authority after admitting to anticompetitively promoting restaurants that exclusively signed onto its service.
Baker McKenzie | USA | 26 Apr 2023
FDA releases DHT framework for clinical data acquisition in drug and biological product development
The use of digital health technologies (DHTs) has accelerated in recent years, especially with the onset of the covid-19 pandemic. The Food and Drug Administration recently issued a framework for the use of DHTs in drug and biological product development. In addition to an overview of the general regulatory background for the use of DHTs and the current DHT landscape, the framework explains......
Lexology PRO | European Union, France | 17 Apr 2023
EU closes French supermarket probe following dawn raid rebuke
The European Commission has closed its collusion probe into French supermarket chains Intermarché and Casino, following a ruling from the bloc’s top court that annulled the agency’s dawn raids on the retail groups.
Grau & Angulo | Spain | 17 Apr 2023
Barcelona Court of Appeal revokes preliminary injunctions that had temporarily prevented marketing of fingolimod generics
The Barcelona Court of Appeal recently revoked the preliminary injunctions that Barcelona Commercial Court No. 10 had granted at the request of Novartis against Viatris, Teva and Reddy. The injunctions had temporarily prevented these companies from marketing generic fingolimod drugs. The Court concluded that the defendants had committed no acts of unfair competition and that their actions......
Lexology PRO | Belgium, European Union | 31 Mar 2023
Belgium blesses first sustainability initiative in banana sector
The Belgian Competition Authority has approved a collaboration between a sustainable trade association and five supermarkets that seeks to improve wages across the banana supply chain, marking the enforcer’s first approval of such an agreement on sustainability grounds.
Sanchez DeVanny Eseverri SC | Mexico | 8 Mar 2023
Mexico aims to curb obesity by imposing publicity restrictions on certain foods and beverages
During the past few years, Mexico has taken one of the most restrictive positions worldwide in connection with food and beverage labelling. Recently, regulatory efforts have focused on the publicity of these products, rather than on the products themselves. This situation complicates the sales of these kind of products and may result in potential abuse and corruption by the competent officials.
Smart & Biggar | Canada | 8 Mar 2023
Federal Court concludes minister of health's decision not to reassess data protection for Spravato in view of CUSMA is reasonable
Following the implementation of the Canada-United States-Mexico Agreement in July 2020, Janssen requested that the minister of health reassess whether its esketamine hydrochloride product (Spravato) was an innovative drug. The minister rejected the request and Janssen filed a further application for judicial review. Justice Manson recently found that the minister's decision was reasonable....
Smart & Biggar | Canada | 1 Mar 2023
Consultation open on Health Canada's proposal on agile licensing for drugs and medical devices
In July 2021, Health Canada announced its intent to amend the Food and Drug Regulations and the Medical Devices Regulations to modernise the regulatory system to permit agile licensing of drugs and medical devices. The proposed amendments to both regulations were recently published for consultation.
