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 AMC completed revision of its procedural rules on merger notifications. The new Merger Regulation significantly reduces disclosure requirements and simplifies filing forms, especially for mergers with no or limited overlaps ...
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 ...
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 ...
While the Ukrainian Parliament continues heated debates over the open market for agricultural land, one thing remains clear - the lifting of the moratorium on sale of agricultural land is an inevitable process, which is largely driven by globalization and the expansion of influence of major world corporate groups in Ukraine. However, for the land market and agribusiness to become transparent and efficient, the relevant risk management systems have to be implemented ...
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 ...
As a general tendency, the public perception of trade unions in Ukraine is rather ambiguous. On the one hand, there is common understanding of the primary role of trade unions as public institutions for protecting the rights and interests of employees ...
In the final 3 months of 2019, the Verkhovna Rada of Ukraine adopted a great number of changes to construction laws. The following Ukrainian laws, among others, saw some significant changes: 1) "On Architectural Activities" No. 687-XIV dated 20 May 1999 ...
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 ...
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 ...
On 30 March 2020, the Ukrainian Parliament adopted the Law "On Amendments to Certain Legislative Acts Aimed to Ensure Additional Social and Economic Guarantees Due to the Coronavirus Disease (COVID-2019) Spread" (the Law), which introduces to the Ukrainian legislative environment new complex rules aimed at minimizing the negative impact of the spread of the COVID-19 in Ukraine. The below summary focuses on key changes introduced by the Law ...
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 ...
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 ...
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 ...
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 ...
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 ...
What is important to consider? Many Ukrainian citizens are forced to stay abroad due to a full-scale Russian invasion. Some were there before the war and could not return, others had to leave Ukraine after February 24. It is clear that something is very difficult to predict at the moment and it can happen that, depending on your circumstances, your stay abroad can be long ...
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 ...
On June 21, 2022, the government adopted Resolution No. 702 , which regulates the procedure for receiving partial unemployment benefits. From now on , self-employed persons and employees who have lost part of their income can count on assistance from the state. However, it should be noted that it is not the employee, but the employer who should seek help ...
In July, the Antimonopoly Committee asked the Ministry of Strategic Industries to update the conditions for providing state aid to companies that develop, manufacture, repair, and service aviation equipment and engines. What to update and how, the committee wrote in recently adopted recommendations . Asters lawyer Olena Gadomska told Mind what the latter envisage, why AMCU is resorting to such changes and who they will affect ...
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 ...
The global trading system has been pushed to its limits since Russia’s invasion of Ukraine 7 months ago. Olesia Kryvetska, a counsel with Asters law firm and head of the Ukrainian Bar Association’s International Trade Law Committee, details the heaviest implications since the beginning of the war, namely soaring commodity and energy prices, food security crises, and supply chain disruptions ...
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 ...
