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 ...
According to recent reports, it seems to be that an exciting update in the aviation world might be waiting around the corner. More precisely, it has been circulated in the media that the global giant and world's fastest growing airline, Turkish Airlines, is contemplating the acquisition of Croatia's national carrier – Croatia Airlines ...
As the overall level of convergence between industries in the business world keeps increasing, it is only logical for the related legal aspects to follow suit every step of the way ...
On May 12th, Governor Snyder issued Executive Directive No. 2016-1 ("ED 2016-1"), which seeks to improve infrastructure in the State by utilizing the Michigan Department of Transportation ("MDOT") in multiple ways. ED 2016-1 requires MDOT to work with a number of agencies, including coordinating with: - The Michigan Department of Environmental Quality to identify and address major infrastructure projects where inadequate facilities could cause threats to water or wastewater services ...
1 Which legislation sets out the regulatory framework for the marketing, authorisation and pricing of pharmaceutical products, including generic drugs? Which bodies are entrusted with enforcing these rules? The relevant legislation includes the following: • Law on Medicines 1996;
In the late 1980s, stories of garbage hauled in the same trucks regularly used to transport fruits and vegetables caused public outrage. Outbreaks of foodborne illnesses, including a salmonellosis outbreak that affected 224,000 consumers, have been attributed to contamination of transportation vehicles. Recently, a major U.S. foodservice distributor was penalized after its practice of storing seafood, milk and raw meat in unrefrigerated sheds was uncovered ...
On April 19, 2016 Association of European Business (hereinafter – “AEB”) and the Russian Federal Antimonopoly Service (hereinafter – the “FAS”) presented the Code of Good Practice in the Pharmaceuticals Industry (hereinafter – the “Code”). The full text of the Code (both in Russian and English) is available at the official web-site of the antimonopoly authority (http://fas.gov.ru/documents/documentdetails.html?id=14513). Below is short outline of the Code. 1 ...
On April 18, the Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services issued revised guidance regarding exclusions imposed under section 1128(b)(7) of the Social Security Act ...
Last January 14, the Communications and Transportation Ministry published the prequalification rules pertaining the international open tender number PO-009000988-N1-2015 awarding the construction of a high speed train project that will run in the route Mexico, D.F. - Santiago de Querétaro, Querétaro, including the definitive executive program, construction, supply, set up and extended testing of a railway track, rolling stock, equipment, systems and other components ...
On January 4th, 2016, the President of the Republic introduced a series of amendments to the bill of law that, “modifies the Health Code in order to regulate generic bioequivalent pharmaceutical products and prevent the vertical integration of pharmaceutical laboratories and pharmacies”, – Bill No. 9914-11- (“Pharmaceutical Bill II”) ...
