The Minister of Health is issuing successive anti-export lists covering an increasingly wide catalogue of products at risk of shortages. This is to ensure access to drugs and medical devices for patients in Poland, especially during the difficult time of the COVID-19 pandemic ...
Q&A procedures before the Public Health Institute (ISP) May I file for sanitary registrations? Requests for sanitary registrations for pharmaceutical products, cosmetics and others regulated, as well as for their modifications, may be filed for through the GICONA portal, and official tariffs shall be paid only through electronic transfer of funds ...
In the context of the current sanitary alert, several bills of law have been filed with Congress, seeking to regulate certain aspects associated to states of emergency and sanitary crises in particular.To such ends, the bills that stand out are:I. Bill prohibiting and penalizing price increases in the face of epidemics or pandemics:On Tuesday 17 March 2020, a bill was filed with the Lower Chamber (Newsletter 13 ...
In recent days, COVID-19 has been the greatest destabilizer worldwide. The World Health Organization defines coronavirus as an extensive family of viruses that cause respiratory infections that can range from common cold to serious health complications such as Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS) ...
INVIMA’s specialized board for Medical Devices and other technologies issued a list of declared as Non-Available Vital Products to attend the emergency arising from COVID-19, which means that the import and / or local distribution of said products will be allowed in Colombia without having a Marketing Authorization ...
Due to the preventive isolation order issued through Decree 457 of March 22nd, 2020 and the powers granted to INVIMA in the sense of guaranteeing the prevention, diagnosis and treatment of Covid-19, within the current state of Economic, Social and Ecological energency ...
Pharmaceutical companies are meeting with numerous legal challenges resulting from the ongoing COVID-19 pandemic and the corresponding Government measures. Among the most discussed topics are the legal obligations relating to availability of medicinal products, securing of medicinal products for treatment of patients with COVID-19, control over the distribution channel, clinical trials, and relations with healthcare professionals ...
Impact of the Czech Government measures on employment relations The current situation has a considerable impact on employment relations ...
COVID II programme – Government financial support for self-employed and small and medium-sized enterprises Aid for self-employed persons ('self-employed') 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 ...
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 ...
Czech Health Ministry's Special Measures UPDATED The government explicitly stated in the Emergency Resolution that the Health Ministry’s existing emergency measures are not to be affected by the state of emergency, which means that they remain valid and must be observed. All the Health Ministry’s special measures introduced valid after the emergency was announced must be observed as well. A brief summary (updated on 19March 2020) is outlined below ...
The offence of spreading coronavirus From what point exactly is the spreading of COVID-19 a criminal offence? Is it only intentional spreading that is punishable or is negligence also a criminal offence? What is at stake? What are the aggravating circumstances and when do the penalties increase? And can these criminal offences also be committed by a legal entity? The Government of the Czech Republic adopted, as a part of emergency measures due to health threat, Regulation No ...
Significant responsibility for ensuring compliance with directives to stop the spread of the Covid-19 virus has been delegated to the law enforcement authorities of the UAE. Last week, the Cabinet promulgated Resolution No. 17 of 2020, requiring all natural and juristic persons to comply with the measures mandated by the concerned authorities to combat Covid-19 ...
The U.S. Environmental Protection Agency has announced its temporary policy regarding environmental enforcement activities during the COVID-19 pandemic. The policy is retroactive to March 13, 2020, and will apply for the foreseeable future, until seven days after EPA gives notice that the policy will terminate. The policy applies to actions for which EPA has federal enforcement authority ...
We knew this year was going to be an especially bad one for the flu. In its November 2019 issue, Scientific American, one of the country's leading science publications, included a twenty-page article titled "The Influenza Outlook", which highlighted the escalating threat of influenza for the year 2020. Unfortunately, at present, the emergence and spread of the novel coronavirus makes the flu pale by comparison ...
The General Meeting during the State of Emergency? Can it take place? And can it be convened? Do crisis measures contain an exception for meetings of the statutory organs of the company (e.g ...
INVIMA adopts measures aimed at efficiently facing the current health situation related to COVID-19, optimizing the processes that allow the commercialization of products necessary for the prevention of the virus and the evaluation of protocols to prevent it. 1. Declaration of products as Vital Unavailable. Due to the shortage of some supplies in general, the authority has declared that masks, antibacterial gel and disinfecting solutions as Vital Products Not Available ...
The Ministry of Health and Social Protection dictates measures tending to guarantee the prevention, diagnosis and treatment of Covid-19 The Ministry of Health and Social Protection has issued Decree 476 of 2020 by which it has decided to make the necessary changes for regulatory requirements to have flexibility in all proceedings related with Pharmaceutical, Phytotherapeutics, Medical Devices, Biomedical Equipment, In-Vitro Diagnostic Reagents, cosmetics and products of Domestic hygie
Covid-19 has had an impact on ongoing consumer contracts and their relations with suppliers. The rapid spread of the virus led the authorities to declare State of Disaster in the country, raising concern about the (i) fulfillment of consumer contracts of goods and services and (ii) an eventual price manipulation ...
Businesses in need of capital may find themselves facing foreign investment regulatory hurdles. We discuss the challenges for businesses and the potential for regulatory relief. Australia's foreign investment regime applies very broadly and captures many transactions. As businesses consider how to respond to the demands of the current COVID-19 economic environment, they may be required to go through the Foreign Investment Review Board (FIRB) screening regime ...
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 ...
State of Emergency Conditions What does "state of emergency" actually meanand what are the powers of the Government in the regard? Can someone claim damages incurred in relation to the state of emergency? State of Emergency With effect from 12 March 2020 at 2 pm, the Government of the Czech Republic (the “Government”) has declared astate of emergency for 30 daysfor the territory of the Czech Republic due to health threats related to the presence of coronavirus in the
Crisis measures issued after the announcement of the state of emergency List as of 14 March 2020 1. Temporary implementation of the protection of internal borders in the Czech Republic Underlying document: Government Declartion No. 197 from 12.3.2020 and extraordinary measures of the Ministry of the Interior dated 13.3.2020 Effectiveness from: 14.3.2020 od 0:00 hod. Effectivness until: 18.3 ...
An article establishing a procedure for the procurement of medical supplies was recently introduced. This new provision (Resolution No 53960) amended Resolution No 38941-2006-JD of February of 2006, which is the general procurement regulation for the Social Security Administration (CSS for its initials in Spanish) ...
