INFARMED has published a set of exceptional measures – which will remain in force during the period of risk to public health – to be adopted by sponsors, clinical trial sites, and research teams, to guarantee the safety, protection and rights of clinical trial subjects.It has also defined INFARMED’s evaluation of trials intended to treat or prevent the new Coronavirus disease (SARS-CoV-2) as a priority ...
The rapid spread of the new Coronavirus (SARS-CoV-2) and the Covid-19 pandemic have led to a very significant increase in demand for medical devices (MDs) and personal protective equipment (PPE), and there was insufficient supply to meet existing needs during the state of emergency and the period that will immediately follow it ...
In some areas, intellectual property will experience a period of slowdown in activity, at least in the near future. We look at this in more detail below. However, this does not mean mandatory registration of industrial property will come to a halt because, with many bodies, including the Portuguese INPI (National Institute of Industrial Property), registration is done online ...
Following the differences that came to light with AstraZeneca at the end of last week, the European Commission approved Implementing Regulation (EU) 2021/111 of 29 January 2021, which came into force on Saturday, 30 January. The Regulation prohibits the unauthorised exportation of vaccines against SARS-CoV-2 outside the European Union ...
Brief notes on Commission Regulation 2021/111 of 29 January 2021 Following the differences that came to light with AstraZeneca at the end of last week, the European Commission approved Implementing Regulation (EU) 2021/111 of 29 January 2021, which came into force on Saturday, 30 January. The Regulation prohibits the unauthorised exportation of vaccines against SARS-CoV-2 outside the European Union ...
Startups relief measures and measures to strengthen the position ofPortugal as a leading international technological hub.On 21 April, the Ministry of Economy and Digital Transition announced a set of relief measures specifically addressed to Portugal’s more than 2500 startups, to mitigate the impact of Covid-19 on the national entrepreneurial ecosystem ...
Published in Corporate Counsel Business Journal March 1, 2023 CCBJ: To start out, please share your background with our readers, including your involvement with the WSG–Legal 500 Survey of In-House Legal Technology. Herman Raspé: I am a partner at Patterson Belknap Webb & Tyler in the capital markets group with a focus principally on equity, but also cross-border debt transactions ...
By: Carol K. Lucas At a time when many are questioning the continued utility and viability of the corporate practice of medicine ban, California may be doubling down. On May 3, 2021, the California Senate Health Committee approved SB-642, the stated purpose of which is to protect medical decision-making from lay control. The bill is currently pending in the California Senate. Assembly Bill AB-705 is a substantially identical bill in the California Assembly ...
On December 29, 2022, the Modernization of Cosmetics Regulation Act (“MoCRA”) was signed into law.[1] MoCRA is the first federal cosmetics law since 1938 and will impose a number of new requirements on cosmetic products and the facilities where they are manufactured. Specifically, MoCRA requires the Food and Drug Administration (FDA) to implement enhanced oversight and regulation of cosmetic manufacturing facilities and products by December 29, 2023 ...
“We simply cannot go on with this utterly outmoded way of working…Endlessly re-keying in the same information; repeatedly printing and photocopying the same documents; moving files about, losing all or parts of them in the process… It is a heavy handed, duplicative, inefficient and costly way of doing our work and it is all about to go. Considerably past time, we will finally catch up with the world.” Sir Brian Leveson ...
Public comment closed August 1 on the rulemaking process for a final ban on TikTok and other social media applications (“apps”) from federal contractors’ devices. The new regulation will expand upon the interim Department of Defense, General Services Administration, and NASA (“the agencies”) ban, which went into effect on June 2, 2023. Over half of all states have banned TikTok on state government devices, with more likely to follow ...
That’s the question Shoosmiths and Cornwall Insight’s recent report sought to answer, investigating the role the Battery-as-a-Service (BaaS) model could play as part of the UK’s electric vehicle charging network. In a new video, Jonathan Smart, partner and head of mobility at Shoosmiths, discusses the BaaS model, which enables electric vehicle owners and business fleets to swap out depleted batteries for fully charged ones at a service station via a subscription service ...
The de novo medical device process is a little-used but potentially valuable means of securing approval for your medical device. The pathway was established in 1997 subject to the Federal Food Drug & Cosmetic Act, Section 513 (f) (2). It was designed to employ a risk-based strategy for novel devices that have not yet been classified. Basically, it establishes a new device type including classification, regulation, appropriate controls and product code ...
One of the key issues raised consistently in the discussions around a no-deal Brexit is the impact it would have on the customs duties payable on goods that are imported in to the UK. Whilst MPs have now voted against a no-deal Brexit, this does not change the legal position – that unless a deal is agreed, there will be a no-deal Brexit, (or no Brexit at all) ...
On 3 October 2019, the European Court of Justice (ECJ) published its groundbreaking ruling in case C-18/18 establishing that the EU enables national courts to order information societies such as Facebook to remove defamatory information. This also encompasses equivalent versions of previously declared illegal information. In doing so, the ECJ effectively held that EU law does not preclude injunctions issued by national courts from producing worldwide effects ...
On October 30, 2012, the U.S. District Court for the Southern District of California ruled that an opt-out confirmation text sent by Citibank (South Dakota), N.A. (“Citibank”) did not violate the Telephone Consumer Protection Act (“TCPA”). Under a “common sense” interpretation, the court determined that Citibank’s opt-out text does not demonstrate the type of invasion of privacy the TCPA seeks to prevent ...
Obligation of Czech employers to protect employees from coronavirusPursuant to Section 106 (1) of the Labour Code, an employee has the right be assured of occupational health and safety protection at work (hereinafter referred to as "OHS"), even during a pandemic.Regarding prevention, the provision in section 102 of the Labor Code remains paramount ...
As a result of the COVID-19 changes to foreign investment in Australia announced on Sunday, investors that are now caught by the Foreign Investment Review Board (FIRB) regime will also be subject to scrutiny from other regulators. Our team explains what this means for investors and what they can do to manage this process ...
Aid for self-employed persons and small and medium-sized enterprises (SMEs) affected by anti-coronavirus measures pursuant to the Czech Government’s 'COVID GUARANTEE' programme was exhausted in one day. On Monday, March 30, 2020, the terms and conditions of the follow-up COVID II program will be published, in which CZK 5 billion should be available. The rush of applications is expected, so action needs to be taken quickly and not delayed ...
Covid III is starting and you need to act fast! At its meeting on 18 May 2020, the Government approved by Resolution No. 553 the Covid III guarantee program for self-employed persons and companies employing up to 500 employees. Immediately afterwards, the websites of Českomoravská záruční a rozvojová banka, a.s. ("ČMZRB") published the conditions of the program ...
The new COVID Prague program focused on business activities in the Capital City of Prague followed the fate of its predecessors COVID I and COVID II. This means that the available funds were exhausted on the same day as the receipt of applications, which thus ends. The COVID I and COVID II programs are also exhausted. Entrepreneurs thus have no choice but to wait for the announcement of the conditions of the COVID III program ...
The state contribution for commercial rents to entrepreneurs with forcibly closed establishments is gaining more concrete outlines. If an entrepreneur negotiates a 30% discount on rent from his landlord, he will be able to apply for state support in the amount of 50% up to a ceiling of CZK 10 million for the period from April to June. However, the program has yet to be notified to the European Commission before it can be launched ...
(continuation from Part I - separate article) Part II - "Antivirus Programme" - Financial Assistance to Czech Employers The Ministry of Labour and Social Affairs was mandated by the Government to further prepare a compensation program for entrepreneurs who continue to operate but whose production has decreased due to measures (category C of the Antivirus Programme) ...
Czech Government Approves Mitigation Measures Related to Coronavirus Emergency UPDATED In connection with the coronavirus emergency, the Czech government has approved a liberation tax package aimed at mitigating the consequences of the emergency ...
Impact of the Czech Government measures on employment relations The current situation has a considerable impact on employment relations ...
