View the February 2017 Health Law Vitals Newsletter PDF. Final Guidance Sheds Light on Medical Device Reporting Requirements In November 2016, the U.S. Food and Drug Administration issued a final guidance on medical device reporting for manufacturers ("Final MDR Guidance") ...
The Ministry of Transport National Infrastructures and Road Safety published a notice regarding a revision to the penalty amounts set out in the Aviation Services Law. Revisions were under the (Compensation and Assistance for Flight Cancellation or Change of Conditions), 5772 - 2012 (the "Law") and the Aviation Services Regulations (Compensation and Assistance for Flight Cancellation or Change of Conditions) (Domestic Flights) 5773-2013 (the "Regulations") ...
Just weeks into the new Administration, perhaps the only certain thing is that there will be uncertainty as the Administration makes its mark and works to fulfill campaign promises. Meanwhile, restaurant chains and food companies are trying to allocate resources to best address business priorities and hot legal issues ...
According to a recent study, 25% of new cars sold around the world will be self-driving by 20351. A group of researchers from Princeton University estimates that by 2035-2050 over half of American cars will be self-driving2. Smart cars are currently being sold in Québec and their advent is sure to have repercussions on several players. Self-Driving Cars Smart cars use information and communication technology in accident prevention systems with varying levels of automation ...
The current EU regulations for medical devices and in vitro diagnostics are from the 1990s. The rapid technical developments in the health care system in recent years as well as the increased cross-border trade urgently require a modernization of the current legal framework. Now the adoption of new EU legislation is imminent. This article provides a brief overview of the planned content and the likely entry into force of the Regulations ...
As the American press focuses on the dismantling of the Affordable Care Act, the wheels have been set in motion to implement new health care legislation that enjoys strong bipartisan support. The 21st Century Cures Act (the “Act”), signed by President Obama on December 13, addresses a broad range of health care priorities, including drug innovation, biomedical research, and mental health reform ...
Under the Affordable Care Act (“ACA”), large employers (generally those with 50 or more full-time employees or full-time equivalents) must report annually to the IRS information about the health coverage offered to their full-time employees during the prior year. Employers also must provide copies of the reports to their full-time employees ...
Karanovic & Nikolic provided complete legal support to Affidea, a largest European medical service provider with respect to opening the first foreign hospital located in Belgrade. Our services consisted of extensive regulatory and corporate advice related to formation and start of operations of Affidea&s first hospital in Serbia. Affidea is one of the largest healthcare investors and operates over 180 Diagnostic and Cancer Treatment Centers in 15 countries across Europe ...
The United States has been a leader in advocating the removal of barriers to competition in the civil aviation market and to this effect has signed more than 120 bilateral Open Skies Agreements with countries around the world. However, not all of Latin America has embraced this policy, with Mexico and Brazil being two of the largest holdouts ...
1. Pharmaceutical market players mostly deal with two regulators These are the Ministry of Healthcare of Ukraine (MOH) and the State Administration of Ukraine on Medicinal Products and Narcotic Drugs Control (SAUMP). The MOH is responsible for state registration of medicines, while the SAUMP deals with licensing, evaluation of good manufacturing practice (GMP) compliance, control over quality of medicines, and regulation of medical devices. 2 ...
Last June 16, the Superior Court of Québec1 rendered a safeguard order in an injunction proceeding in favour of a health-care institution the purpose of which was to set conditions for the visits of the daughter of a user of the institution who was an incapable person lodged there, as well as her interactions with the user and the staff ...
The Minister of Transportation has issued Minister of Transportation Regulation No. PM 32 of 2016 on the Organization of Non-Fixed-Route Public-Transportation Services. This regulation addresses the ongoing dispute between the existing transportation companies and application-based transportation services ...
Karanovic & Nikolic is pleased to have advised on the recent public procurement case in which our client – the seller – provided the City of Belgrade with five new electric buses for the city's public transport system. The team that led the client throughout the process was represented by Marjan Poljak, Partner, and Ana Stankovic, Senior Associate ...
In the last several years, Texas has generated significant news stories related to the disagreements between the Texas Medical Board (“TMB”) and Teladoc, a telehealth medical provider. The original dispute centered around the right of telemedicine providers to treat Texas residents without an initial in-person visit, which some would argue circumvents the establishment of the practitioner-patient relationship ...
Montenegrin media outlets have recently reported that the initial phase of the tender for the pre-qualification procedure in awarding the concession for the Kotor-Lovcen-Cetinje cableway – announced on 3 August in the Official Gazette of Montenegro – will be open to interested parties until 5 October this year ...
Consent to End-of-Life Care Article 11 of the Civil Code of Québec1 states that no one can be made to undergo care without his consent. The Act respecting end-of-life care2 ("the Act"), passed by the National Assembly of Québec, came into force on December 15, 2015. Since that date, a person can give or refuse consent to specific forms of end-of-life care, provided he has given advance medical directives ("AMDs") for that purpose ...
On July 25, 2016, China Food and Drug Administration (“CFDA”) published the latest "Measures for the Administration of Drug Registration (revised draft)” (“Latest Revised Draft”) for public comments1 ...
Global competition law circles have recently been shaken by the European Commission's record-setting fine of EUR 2.93 billion for collusion on the automotive market, imposed against Volvo, Daimler, Iveco and DAF trucks. The sanctions in question varied amongst the accused parties, with Daimler facing the largest penalty in the amount of more than EUR 1 billion on its own. Iveco's fine was set at EUR 494 million, DAF's at EUR 752 million, and Volvo's fine has been set at EUR 670 million ...
The Health Care Arbitral Tribunal (Arbitral Tribunal) has pronounced a decision on a dispute between an independent medical specialist and a Medical Specialist Company (MSC) for the first time since the introduction of the comprehensive rates on 1 January 2015. Although neither party has terminated the existing (membership) agreement between them, the Arbitral Tribunal is of the opinion that termination of membership and deregistration of the specialist from the members' register are justified ...
Under the Convention on the Contract for the International Carriage of Goods by Road ("CMR convention") and the Finnish Road Transport Act, a carrier is, as a general rule, liable for loss of and damage to the goods occurring during the transport as well as for any delay in delivery ...
On May 10, 2016, the Québec Court of Appeal1 confirmed a Superior Court decision allowing an application for authorization of treatment and placement to a patient. The application had been brought by the Douglas Mental Health University Institute, commonly known as the Douglas, or the Douglas hospital ...
In a unanimous decision rendered on May 16, 2016,1 the Québec Court of Appeal confirmed that the delivery of ophthalmic lenses purchased online from suppliers who are not members of the Ordre des optométristes (Order of Optometrists) (?Order?), or the Ordre des opticiens d?ordonnances (Order of Dispensing Opticians), does not violate the Optometry Act 2(?OA?) or, by necessary extension, the Dispensing Opticians Act ...
The Minister of Transportation has issued Minister of Transportation Regulation No. PM 32 of 2016 on the Organization of Non-Fixed-Route Public-Transportation Services. This regulation addresses the ongoing dispute between the existing transportation companies and application-based transportation services ...
The Montenegrin Ministry of Transport has recently been in the news as it provided an overview of investments that it has made over the past ten years in the country's road infrastructure – investments that have totalled at EUR 300 million through renovation, modernisation, and construction processes throughout the country ...
We are pleased to announce that Karanović & Nikolić has advised Jet Airways (India) Limited, together with Dentons UKMEA LLP, in an aircraft leasing transaction that will enable the long-haul trans-Atlantic route between Serbia and the United States (Belgrade-New York) to be restored ...
