We would like to inform you about several important news items, in the pharmaceutical industry, at the beginning of 2021. The Rules of registration and assessment of medicines for medical use in the EAEU come into force According to the Decision of the Eurasian Economic Commission Council (“EEC”), dated November 3rd 2016 No ...
A new ordinance enacted by SENACON became effective on February 5 bringing changes to the execution of Terms for the Adjustment of Conduct (“TAC”) in administrative proceedings before SENACON, revoking the previous ordinance. The ordinance provides for several phases in the process of execution of a TAC, which will begin with a request, analysis of the feasibility of the negotiation, the negotiation itself, followed by authorization and subsequent decision ...
The Supreme Court has issued Supreme Court Administrative Matter No. 20-12-01-SC (Re: Proposed Guidelines on the Conduct of Videoconferencing) dated December 9, 20201 (Court Videoconferencing Guidelines) to ensure that hearings via videoconferencing are conducted in an orderly manner and that the constitutional rights of the accused are protected ...
As a developing country, Indonesia is still considered to have limited Government fiscal capacity and limited state-owned enterprise (Badan Usaha Milik Negara – “BUMN”) and financial sector funding capacity indicating that domestic capacity is not sufficient to meet what is needed to finance development and support economic growth and opportunities ...
Over the next decade, challenges around public funding and a shift in live/work priorities will create an increasing need for public-private collaboration as we seek to rebuild and regenerate our towns and cities in a post-Covid and post-Brexit climate ...
Historically, New York State has not required the registration of investment adviser representatives (IARs). New York has adopted regulations providing registration and examination requirements for IARS. This article focuses upon the examination and registration requirements applicable to IARs of federally covered investment advisers. The newly adopted regulations became effective Feb. 1, 2021 ...
In recent years, with the continuous improvement of science and technology standards in China, the country’s cryptography technical capabilities have also begun to enter the global forefront. In turn, China has promulgated various policies and measures to fulfill its non-proliferation obligations, which have promoted the gradual implementation of control measures for the export of cryptographic technologies ...
&The U.S. Court of Appeals for the Federal Circuit, in BGT Holdings LLC v. United States, 1 recently held that the government does not have the discretion to deny a contractor's request for equitable adjustment (REA) under Federal Acquisition Regulation (FAR) 52.245-1 (Government Property) where the conditions specified in that clause are present and the contractor is able to show financial loss ...
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 ...
The Minister of Communication and Informatics (“MOCI”) has finally issued MOCI Regulation No. 5 of 2020 on Electronic System Organizers (“ESO”) in the Private Sector (“MOCI Regulation 5/2020”) that serves as the new implementing regulation of Government Regulation No ...
On 30 December 2020, Bank Indonesia issued Bank Indonesia Regulation No. 22/23/PBI/2020 of 2020 on Payment Systems (“Payment Systems Regulation”). The Payment Systems Regulation is intended to serve as an “umbrella” regulation that provides a regulatory framework for the Indonesian payment systems industry. This regulation will come into force on 1 July 2021 ...
On 4 January 2021, the President of Republic of Indonesia issued Regulation No. 2 of 2021 on the Ratification of the Convention Abolishing the Requirement to Legalize Foreign Public Documents (“PR 2/2021”) (the convention is hereinafter referred to as the “Apostille Convention”). The Apostille Convention was concluded on 5 October 1961 and is intended to simplify a series of formalities for documents signed overseas for the contracting states ...
Traditionally, Dutch mortgage lenders have always found themselves in quite a good position in the event of their borrower and mortgagor becoming insolvent. As a firm general rule, it is fair to say that the position of a secured creditor is quite secure under Dutch law. Recent insolvency and COVID related regulations have, however, made some inroads into the Dutch secured lender’s stronghold ...
Following the renewal of the state of emergency, Decree 3-A/2021 of14January of the Presidency of the Council of Ministers, determines the closure of various types of establishments. Inthiscontext, the employment support measures were amended by Decree-Law 6-C/2021 of 15 January and Decree-Law 6-E/2021 of15January, which we summarised below. 1 ...
Physicians, physician assistants, and advance practice nurses who have sought to treat opioid-addicted patients with Schedule III-V Controlled Substances that have been approved by the United States Food and Drug Administration for that indication have had to apply for a waiver under the Drug Addiction Treatment Act of 2000. Eligible medications are presently limited to buprenorphine-containing products such as Suboxone and Subutex ...
On February 1, 2021, the Federal Trade Commission (FTC) announced its revised annual threshold that determines whether companies may be required to notify federal antitrust authorities about a proposed merger or acquisition due to the size and value of the transaction. For the first time since 2010 and a reflection of the state of the economy, the annual threshold has been reduced rather than raised, from $94 million in 2020 to $92 million for 2021 ...
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 ...
Dr Michael Psaila, Managing Partner of Mamo TCV Advocates, underlined the firm’s commitment to the visually impaired and the Malta Guide Dogs Foundation (MGDF) in particular when he not only presented a donation but committed the firm to assisting the foundation in its legal affairs in the coming years. It was the wish of the firm, which has a staff complement of over 70 people, to select the MGDF as one of the beneficiaries of their annual charity donation ...
The Electronic Communications Code was subject to a wholesale re-write in 2017, with the intention of facilitating the faster roll-out of the UK’s digital communications infrastructure. Three years on, the government has commenced a consultation on proposals to revise aspects of the Code to ensure it is fit for purpose ...
The Pension Protection Fund (PPF) has published its determination for the levy year 2021 to 2022, following its autumn consultation. Ordinarily, the PPF considers matters across the levy triennium with a view to keeping the rules relatively stable on a triennial basis. However, in considering the impact of COVID-19 on schemes, the PPF wishes to take a more flexible approach with the aim of switching back to a multi-year approach in 2023/24 ...
On Jan. 19, 2021, the two recent final rules issued by the Department of Health and Human Services Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) regarding changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (Stark Law) regulations (respectively the OIG Rule and the CMS Rule, collectively the Final Rules) became effective ...
Bank Negara Malaysia issues Licensing Framework for Digital Banks Bank Negara Malaysia issued its policy document on Licensing Framework for Digital Banks on 31 December 2020. It has indicated in its press release that up to five licences may be issued to qualified applicants and notification of the grant of licence will only be made by the first quarter of 2022 ...
