1. Pharmaceutical market players mostly deal with two regulators These are the Ministry of Healthcare of Ukraine (MOH) and the State Administration of Ukraine on Medicinal Products and Narcotic Drugs Control (SAUMP). The MOH is responsible for state registration of medicines, while the SAUMP deals with licensing, evaluation of good manufacturing practice (GMP) compliance, control over quality of medicines, and regulation of medical devices. 2 ...
On 19 June 2022 Kyiv hosted Recovery Forum Ukraine 2022 organized by the Confederation of Builders of Ukraine, KyivBuild Ukraine, Aquatherm Kyiv and ReBuild Ukraine. The event gathered the representatives of the state and local authorities, construction business-community, international financial institutions, and potential investors to discuss issues related to the rebuild of the damaged infrastructure in Ukraine as well as the ways of financing ...
On June 21, the President signed a law ratifying the Council of Europe Convention on Preventing and Combating Violence against Women and Domestic Violence (hereinafter referred to as the Convention). The day before, the law was passed by the Verkhovna Rada, 259 people's deputies voted for ratification, and only eight opposed it ...
Following the global trend for tax transparency and fighting harmful tax practices, Ukraine finally adopted its ownanti-BEPS package law, known by businesses and tax practitioners as "tax bill 1210". Asters selected the key takeaways for businesses operating across the borders. The law is in effect starting from 23 May 2020 with some provisions taking effect later. I ...
Asters' Counsel and pro bono legal advisor of the Committee on Industrial Ecology and Sustainable Development of the European Business Association (EBA) Anzhelika Livitska contributed to EBA White Paper "Deregulation of environmental legislation in a time of war and reforms aimed for European integration" ...
Those seeking reasons to be optimistic about Ukraine’s judicial system can rejoice: Justice prevailed, or so ruled the High Commercial Court of Ukraine, the likely final arbiter in a dispute between the state Antimonopoly Committee of Ukraine and ACNielsen Ukraine, a market research firm ...
Cloud computing, along with Big Data, social media, and mobility, is one of the current megatrends that will drive huge changes to the business ecosystem in the upcoming decade. Surveys held over the recent years unanimously confirm that organisations across the globe are rapidly and continuously moving to the cloud ...
On 18 March 2020, the President of Ukraine signed a new law that introduces social tax, land, and property tax incentives during the quarantine period to include tax exemptions, postponement of tax audits and possibility to postpone tax payments. By possibility of postponement we mean that statutory deadlines for payment are not changed, but payment can be delayed with no penalty and interest ...
Below is a summary of key regulatory measures and restrictions introduced by Ukraine in response to a public health challenge caused by COVID-2019. This update speaks only as of its date. As the situation is highly dynamic, we encourage our clients to approach us directly for an up-to-date guidance. Immigration Foreign citizens are temporarily banned from entering Ukraine ...
Two months ago, in mid-April, the European Parliament approved the first legislation in the European Union on tracking payments in cryptocurrencies, supervision in this area and combating money laundering. The MEPs also adopted common rules for the supervision and protection of consumer rights (MiCA, or Markets in Crypto assets) with safeguards against market manipulation and financial crimes ...
The morning of February 24 began as an ordinary day for IP attorneys Julia Semeniy and Yuliya Prokhoda, with planned court hearings, client meetings and routine school runs in Ukraine. But when Russia began its onslaught on the country, in an act of internationally condemned aggression, their lives changed dramatically ...
Infrastructure 1 Is your state a party to the New York Convention? Are there any noteworthy declarations or reservations? Yes, Ukraine is a party to the New York Convention. It was ratified in 1960 by the Ukrainian Soviet Socialist Republic (SSR) (as a part of the former Soviet Union). Following the declaration of independence in 1991, Ukraine confirmed its obligations under all international treaties entered into by the Ukrainian SSR, including the New York Convention ...
Rozhen, who has dealt with paperwork at least once in his life, understands how important the role of a notary is. The notary certifies the powers of attorney of individuals, wills, contracts for the alienation of real estate, issues certificates of the right to inheritance and performs many other notarial acts ...
On February 24, a lot changed in Ukraine, and the judicial system was no exception. What new has the full-scale invasion of the Russian Federation brought to the resolution of legal disputes and what does the judiciary look like under martial law - we will consider further. The first months after the invasion Immediately after the Russian invasion, the courts took some time to recover from the shock ...
Due to introduction of restrictive measures in the territory of Ukraine during the quarantine period, the National Bank of Ukraine (hereinafter the "NBU"), by its Resolution No. 39 dated 26 March 2020 (the "Resolution"), introduced special rules for application by the banks of Ukraine of the requirements of the Regulation on determination by banks of Ukraine of the credit risk on active banking operations, approved by the Resolution of the Board of the NBU No. 351 of 30 June 2016 ...
One year ago, on June 21, 2022, the President signed the law on the ratification of the Council of Europe Convention on the prevention of violence against women and domestic violence and the fight against these phenomena. The Convention entered into force for Ukraine on November 1, 2022 ...
1 Which legislation sets out the regulatory framework for the marketing, authorisation and pricing of pharmaceutical products, including generic drugs? Which bodies are entrusted with enforcing these rules? The relevant legislation includes the following: • Law on Medicines 1996;
The rules of state aid work for the implementation of public-private partnership projects and require the state, as a partner, to comply with the conditions of the transfer of budgetary resources to private partners, in order to avoid a ban on the conclusion of state contracts due to the incompatibility of state aid with economic competition. The Ministry of Economy proposed a plan to restore Ukraine with a price tag of $750 billion of budget funds ...
According to official statistics, almost 104,000 couples got married in Ukraine during the first half of such a difficult year of 2022. It is interesting that during the same period of 2021, a little less than 86 thousand couples exchanged marriage vows. Such indicators indicate that the full-scale war did not prevent those who have a desire to create new families ...
Military action has made adjustments to the activities of the vast majority of companies in Ukraine. Unfortunately, for many employers, the issue of revising the terms of remuneration of staff in the direction of reduction has become relevant. The Law of Ukraine “On the Organization of Labor Relations in Martial Law” (the Law), which entered into force on March 24, reminded of the restriction of the constitutional right to work for the period of martial law ...
The military aggression of Russia and its satellites against Ukraine is not only a personal tragedy of Ukrainians and a threat to the existence of Ukrainian statehood. It also has an economic dimension in the form of huge material losses suffered by both Ukraine in general and each citizen in particular ...
