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Carey | February 2023

On February 14 of this year, the Public Health Institute ("ISP") approved -by means of Ex. Res. No. 369/2023- a new guideline regarding the performance of post-authorization safety studies of pharmaceutical products (the "Guideline") ...

Carey | February 2023

On February 20 of this year, the Public Health Institute (hereinafter "ISP"), approved through Exempt Resolution No. 405/23 the technical guide on homeopathic products with the purpose of providing the guidelines and requirements for the request of the sanitary registration of these pharmaceutical products in order to provide complete and updated information that supports the quality, safety and efficacy of these products (the "Guide") ...

Buchalter | April 2022

April 19, 2022 By: T. Mark Tubis The U.S. Department of Health and Human Services (“HHS”) has renewed the January 31, 2020 determination that a public health emergency (“PHE”) exists nationwide. Each determination renews the PHE for 90 days, so all HHS/CMS waivers and flexibilities applicable during the PHE will continue until at least July 15, 2022, unless the PHE is terminated sooner ...

Heuking | August 2019

Although under the Treaty on the Functioning of the European Union, the European Commission has limited power regarding infrastructure policy, which remains a Member state competence, recent rulings of the ECJ regarding ports and airports have allowed it to extend its role in this area by applying the State aid rules to infrastructure financing ...

Heuking | July 2020

The German government launched an aid program to support start-ups and young growth companies in the corona crisis aimed at providing start-ups with liquidity quickly. One of the pillars of this program is the Corona Matching Facility (CMF), where KfW Capital and the European Investment Fund (EIF) are “matching” investments of private venture capital funds (VC funds). The aid is therefore linked to the investments of VC funds ...

Wardynski & Partners | April 2020

The pandemic requires immediate response and rapid launch of solutions for combating the coronavirus and its socio-economic impacts. Thus the Anti-Crisis Act includes provisions allowing contracts for fighting the pandemic to be awarded without following lengthy formal procedures. It usually takes along time from commencement of proceedings for award of apublic contract to conclusion of acontact with the selected contractor ...

PLMJ | September 2022

The strategy for the application of Portugal 2030 was designed around five main objectives of the European Union1: a smarter, greener, more connected, more social Europe that is closer to its citizens. At the national level, these strategic objectives of the European Union are embodied in four thematic agendas of the Portugal 2030 strategy2 ...

What will the impact be when the Scottish Parliament Finance Committee reports on Accountability and Governance asks Kelly Harris The Finance Committee of the Scottish Parliament has been conducting an inquiry into Accountability and Governance in Scotland, looking at the proliferation of Commissioners and Ombudsmen established since devolution. The impetus behind the inquiry was the growing concern that money might be being wasted as a result of overlapping functions and responsibilities ...

Shoosmiths LLP | June 2022

The UK is facing a series of economic shocks, fuelled by the increased cost-of-living, the Ukraine war hitting the global supply chain, and lasting disruption of the Covid-19 pandemic. The combination of issues has led to shifts in shopping behaviours, working patterns and residential needs, while also impacting demand for space in traditional retail and leisure districts. Remedial action is needed to deal with these pressures and the resultant damage to UK high streets ...

Dinsmore & Shohl LLP | October 2019

With the recent proliferation of mass shootings and other deadly incidents, several states have taken on the issue of allowing mental and/or emotional impairments caused by post-traumatic stress disorder (PTSD) to be a compensable workers’ compensation condition for first responders without the requirement of a physical injury. In June 2019, House Bill 80, the budget bill for the Ohio Bureau of Workers’ Compensation, included such a proposal ...

Today, May 10, Legislative Decree No. 1486 that establishes new provisions, and modifies and/or expands various regulations for the effective execution of investments by public entities has been published ...

Wardynski & Partners | July 2022

Persons using medical services in Poland are subject to special legal protection. Regardless of their nationality, all patients have the same rights. Our guide explains the key patient rights and legal solutions concerning citizens of Ukraine. A guide prepared by Małgorzata Sokołowska and Natalia Falęcka-Tyszka from the firm’s Healthcare practicehttps://wardynski.com.pl/upload/2022/04/realizacja-swiadczen-opieki-zdrowotnej_en ...

Brigard Urrutia | May 2020

The Ministry of Health and Social Protection was given the authority to determine and issue biosecurity protocols to mitigate, control, prevent the spread and properly manage the COVID-19 Coronavirus pandemic. It is necessary to emphasize that all companies that reactivate their work must establish timely channels of communication between the employer and the worker to notify suspicious cases ...

Carey | July 2022

On July 4th, 2022, three months after the deposit of the instrument of accession before the Director General of the World Intellectual Property Organization, the "Protocol Relating to the Madrid Agreement Concerning the International Registration of Marks" (the "Madrid Protocol") entered into force in our country. The accession determined that Chile joined the Madrid System, which covers 128 countries. The Madrid System contemplates a centralized trademark application and management process ...

A battle is heating up in the Jan. 6 criminal case against former President Donald Trump that, while seemingly technical, will likely have a significant impact on the defendant’s ability to mount a defense. It may well serve as a bellwether for how the court will resolve future similar procedural disputes. On Aug ...

Shoosmiths LLP | August 2022

A year after Ms Maya Forstater succeeded in establishing in the Employment Appeal Tribunal that gender-critical beliefs are a protected philosophical belief under the Equality Act 2010, she has won two of her claims for direct discrimination and one claim for victimisation. Employers need to tread very carefully both to balance individual employees' rights to hold sometimes conflicting protected beliefs and to foster a culture that is truly inclusive ...

Dinsmore & Shohl LLP | July 2019

As seen on Law360: The 2018 Farm Bill[1] relaxed restrictions covering hemp-based cannabis products, and it is causing a shift in business strategies in the industry. Instead of a full prohibition of trademark registrations covering cannabis goods or services, a narrow range of filings is now permitted, so long as they conform to the requirements of the Farm Bill and the latest USPTO guidelines ...

Carey | July 2021

As of today, July 26 the Chilean borders will open so that all those who have a “Mobility Pass” can exit the country, although current restrictions for non-resident foreigners have been maintained. The is subject to modification in view of the development of the Covid-19 outbreak in the national territory ...

Dinsmore & Shohl LLP | November 2018

Recently, the Ohio Department of Medicaid (ODM) proposed the adoption of Ohio Administrative Code 5160-1-32.1 (the Proposed Rule), which provides two standard authorization forms for the use and disclosure of protected health information (PHI). The standard forms are designed to comply with both the HIPAA privacy rule (45 C.F.R. § 164.508) and 45 C.F.R. Part 2, which covers certain substance abuse treatment information ...

In another step in President Trump's ongoing efforts to relax environmental restrictions impacting economic development, on January 10, 2020, the Council on Environmental Quality published its proposed rulemaking to update its regulations for implementing procedural provisions of the National Environmental Policy Act ("NEPA") ("Proposed Rule"). The deadline for filing comments on the Proposed Rule is March 10, 2020 ...

Hanson Bridgett LLP | November 2018

Article PDF   On October 19, 2018, the Treasury Department released proposed regulations regarding certain aspects of the new qualified opportunity funds ("QOF") and related qualified opportunity zones ...

Dinsmore & Shohl LLP | October 2019

CFIUS inbound investment national security review expanding to certain non-controlling foreign investments in critical technology, critical infrastructure, and sensitive personal data, as well as to certain real estate transactions.  The U.S. Treasury Department published proposed rules in the Federal Register on Sept. 24, 2019, concerning changes to the review process for foreign investment conducted by the Committee on Foreign Investment in the United States (CFIUS) ...

Dinsmore & Shohl LLP | January 2020

In December of 2019, the State of Ohio Board of Pharmacy (“Board”) proposed rule changes for medical marijuana dispensaries. These proposed rule changes came on the heels of increased regulatory scrutiny of ownership structures and consulting arrangements in recent months.1 The proposed rules ostensibly seek to revise and clarify the Board’s position on changes of ownership and control of medical marijuana dispensaries ...

Deacons | November 2020

Hong Kong’s Financial Services and Treasury Bureau (FSTB) issued a public consultation paper on 3 November 2020 (Consultation) proposing the introduction of a licensing regime for virtual asset services providers (VASPs), as well as other changes to Hong Kong’s anti-money laundering regime ...

Haynes and Boone, LLP | October 2011

President Obama recently sent to Congress proposed legislative language and analyses of his proposed deficit-reduction plan. Among the proposed legislative changes is a change to the formula used for calculating the cap on the amount that the federal government will reimburse federal contractors for executive compensation ...

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