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 ...
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 ...
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 ...
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 ...
In the wake of the COVID-19 outbreak, the business community is faced with unprecedented threats to their cyber-infrastructure and data. Sensitive data, in particular, will be vulnerable to security breaches as a result of reduced human power under emergency legislation. Moreover, criminal hackers will be looking to capitalize on such vulnerabilities at a time like this ...
Through External Circular No. 001 of March 23, 2020, the Superintendence of Industry and Commerce (SIC) made clear that mobile phone operators and private entities in general have legal grounds to provide to the National Planning Department (DNP), as well as to public entities that so require it, personal data that is necessary to address, prevent, treat and/or control the spread of COVID-19 and mitigate its effects ...
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 ...
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
As if businesses did not have enough to worry about during this COVID-19 pandemic, it’s times like these when cybersecurity risk is at its peak. Distracted employees may be psychologically vulnerable to attack, and shifting quickly and unexpectedly to a remote workforce can create technology and control risks. It’s a perfect storm for cyber risk ...
The identification of the food and drink sector as key in the response to the COVID-19 (C19) crisis seems obvious and unquestionable. Scratch the surface though and questions emerge, perhaps unsurprisingly because of the haste with which the emergency legislation was passed. The starting point recognised in the Coronavirus Bill was that the food supply chain involved not just producers but also intermediaries ...
In the turmoil of adjusting and living day-to-day in this time of the COVID-19 virus, the public has become more attuned to the reality of the term “Supply Chain.” We are gaining a better appreciation that before products reach the consumer, an extensive network of shippers and transportation entities of all types and modes of commerce, as well as freight brokers and any other functions essential to the delivery cycle, are at play 24/7 ...
FDA Takes Action to Increase U.S. Supplies in Response to COVID-19. The FDA took action to increase U.S. supplies to support the U.S. response to COVID-19 by providing instructions to manufacturers importing personal protective equipment and other devices. The FDA is engaging the import trade community during this pandemic to facilitate the entry of needed products, including PPE, into the U.S ...
FDA Warns Consumers About Unauthorized Fraudulent COVID-19 Products.The FDA issued a Consumer Update advising consumers to be beware of fraudulent coronavirus tests, vaccines and treatments. The FDA has seen unauthorized fraudulent test kits for COVID-19 being sold online. Currently, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19 ...
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) ...
The FDA revised its guidance on postmarket adverse event reporting for medical products and dietary supplements during a pandemic to apply the guidance to the ongoing COVID-19 pandemic. The FDA acknowledges that companies, and the agency, itself, may be hit with workforce shortages during a pandemic at the same time that adverse event reporting for products deployed for the pandemic may increase ...
The U.S ...
The FDA issued immediately-in-effect guidance to accelerate the development of certain laboratory tests for the urgent need caused by SARS-CoV-2. The FDA provides recommendations, among others, for serological tests, puts forth a policy for states to take responsibility for tests, and announces enforcement discretion for commercial manufacturers using new commercially developed tests prior to the FDA granting an emergency use authorization, under certain circumstances ...
To help prevent disruptions in the food supply-chain during the COVID-19 pandemic, the FDA issued a temporary policy for Food Safety Modernization Act (FSMA) supplier verification onsite audit requirements. The policy states that the FDA will temporarily not enforce FSMA supplier verification onsite audit requirements if other appropriate supplier verification methods are used instead ...
A trend is emerging with recently filed litigation involving the COVID-19 pandemic. Spilman attorneys are committed to providing information that allows businesses to react as quickly as possible to avert civil litigation threats or to protect your interests through litigation. Monitoring these litigation trends will allow organizations to prepare to defend against such threats in the future or to identify and pursue civil remedies when needed ...
