On February 17, 2017, the Bureau of Ocean Energy Management (“BOEM”) withdrew its December 2016 orders requiring sole liability properties to provide additional security in the form of supplemental bonds for plugging, abandoning, and decommissioning Outer Continental Shelf (“OCS”) wells, platforms and other facilities ...
U.S. Prudential Regulators and European Supervisory Authorities Follow CFTC in Issuing Regulatory Guidance Regarding March 1, 2017 Variation Margin Deadline, But Relief is “Risk” Based Last week we issued an alert advising of No-Action Letter 17-11 issued on February 13, 2017 by the U.S ...
CFTC Issues No-Action Relief to September 1, 2017 for Variation Margin Rule for Uncleared Swaps, But for Swap Dealers under Prudential Regulators’ VM Rule the March 1, 2017 Deadline Remains On February 13, 2017, the Staff of the U.S. Commodity Futures Trading Commission (“CFTC”) issued time-limited no-action relief (Letter No ...
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") ...
As part of the implementation of the Mexican energy reform of 2013, several new regulations and administrative guidelines affecting the hydrocarbons and power industries were issued during December 2016 and January 2017. These are of particular importance to oil and gas producers, power generators and others looking to invest or expand operations in Mexico’s dynamic energy sector. I. Hydrocarbons December 2, 2016. Open season exemptions for natural gas pipelines ...
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 ...
In May 2016, the Division of Corporation Finance of the Securities and Exchange Commission (“SEC”) added new Compliance & Disclosure Interpretations (“C&DIs”) to the existing catalog of C&DIs that addresses disclosures of“non-GAAP financial measures ...
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 ...
The Competition Commission found that the company EPS Distribucija, the only operator of the electricity distribution network in Serbia, abused its dominant position in the market of electricity distribution in Serbia. The abuse consists of applying dissimilar conditions to equivalent transactions with trading parties, whereby some of those trading parties have been placed at a competitive disadvantage in comparison to their competitors ...
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 ...
ENSafrica’s MOHS department recently represented AngloGold Ashanti Limited in a South African Labour Court case, which has culminated in a judgment that sets out important legal principles and requirements. These relate to the instructions issued by Inspectors of Mines in terms of section 54 of the Mine Health and Safety Act, 1996 (the “Act”) ...
Latest news reports are informing us that the European Energy Community (EC) went back on their threats of suspending Serbia's membership, after a series of fruitful negotiations between EC's representatives and the Serbian Ministry of Energy. The agreement which allowed for this development stipulates that Serbia has accepted the plan of action regarding the restructuring of Srbijagas, at the same time complying with the requirements of the Third Energy Package ...
Recent news bring us an update from the Energy Community (EC), whose latest report has outlined that Serbia has not resolved the key issue of non-compliance with the aquis – something that presents a continuous violation of obligations under the EC Treaty – by not completing the separation of Srbijagas and Yugorosgaz activities in accordance with the "Second Energy Package" ...
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 ...
In the past several years, the Consumer Product Safety Commission, the Department of Transportation, the Department of Agriculture, the Food and Drug Administration, and other government bodies have mandated recall of hundreds of products from the market.In some cases, companies have voluntarily recalled products due to their potential for risk of injury ...
According to latest media reports, the governments of Serbia and Bulgaria have agreed on the formulation of a new memorandum for the task of building a gas pipeline between the two countries, during a recent meeting of the group for gas connections in Central and South East Europe that was held in Budapest ...
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 ...
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 ...
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 ...
The Mexican government announced the second bid of Round 2 on August 23, 2016. This will be the seventh upstream bid round in Mexico since passage of the energy reform in mid-2014. The new bid round (named Round 2.2), comprises 12 onshore blocks for exploration in the Burgos and Southeastern Basins, covering collectively 5,006 km2 , with prospective resources of approximately 643.2 million barrels of crude equivalent and an original volume of approximately 93 ...
The Act of 22 July 2016 Amending the Energy Law and Certain Other Acts was published on 2 August 2016. The act is intended to eliminate the black market in fuels, strengthen competition on the market, and improve Poland’s energy security. The amendments introduced by the act primarily concern the market for natural gas and liquid fuels ...
On July the 27th 2016, Law No. 20.936 that establishes New Power Transmission Systems and creates an Independent Coordinating Body for the National Power System (the “Transmission Law” or “New Law”) was published. Its stated objectives are to ensure that transmission does not become an obstacle to power generation, increase competition in the electrical market and boost the development of non-conventional renewable energies ...
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 ...
