LEGAL UPDATES
14 July 2016

Ukraine is changing the regulatory landscape for pharmaceutical business

On 31 May 2016, Ukrainian Parliament passed a law[1] to significantly simplify the market access for certain categories of medicinal products. In particular, the law introduces a streamlined registration (marketing authorization) process for any drugs already authorized by competent authorities of (i) the U.S., Switzerland, Japan, Australia, Canada and (ii) the EU under centralized authorization procedure, in each case for use in relevant countries. Such registration is to be performed within 17 business days and involve a limited documentation check, without a full-scale local review of the registration dossier. The law entered into effect on 19 June 2016. However, bringing it to life still requires approval of a number of by-laws that are being developed by the Ministry of Health of Ukraine. When implemented, simplified registration procedures are expected to reduce the market entry barriers for international pharmaceutical business.

6 July 2016

Companies will be obliged to collect and disclose information on their beneficial owners

According to a new Russian law, legal entities have to obtain and keep information on their beneficial owners, and to renew this information on a regular basis (at least once a year)

24 March 2016

Ukraine signed the Hague Convention on Choice of Court Agreements

On 21 March 2016, Ukraine signed the Hague Convention of 30 June 2005 on Choice of Court Agreements (“Convention”). This is a major step towards integration of Ukraine into European and global trade and investment environment. Availability of choice of court agreements in Ukraine will ensure yet another instrument of legal protection for businesses engaging in trade with Ukrainian parties or investing into the country.

15 March 2016

Control over the processing of Russian citizens’ personal data is tightened

Since September 2015, both foreign and Russian companies have been required to use databases located in Russia to process Russian citizens’ personal data (PD) (the so-called data localization rule).

1 March 2016

The New Status of News Aggregators: What Next?

In late February 2016 a draft law (No. 1004188-6) setting out to regulate the operations of so-called news aggregators was submitted to the State Duma. The reaction from the business community has been mixed, and public authorities are taking different views too. For example, German Klimenko, the Presidential Adviser on Internet Development, supported the initiative, while Deputy Minister Alexey Volin says the Ministry of Communications and Media does not support the draft law, which equates news aggregators and media.

25 February 2016

Single Pharmaceutical Market in the Eurasian Economic Union

On February 11, 2016 the Federal Law “On Ratifying the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Goods and Medical Equipment) Within the Framework of the Eurasian Economic Union” and Federal Law “On Ratifying the Agreement on Common Principles and Rules for the Circulation of Pharmaceuticals within the Framework of the Eurasian Economic Union” (Agreements) came into force.

19 February 2016

Three Russian giants – Sberbank, Gazprom and MTS Get Monopolies on Their Corporate Colours: Shades of Green, Blue and Red

In late 2015 and early 2016, Rospatent registered red, green and blue colours as trademarks for Sberbank, Gazprom and MTS. The companies have, therefore, secured their right to the particular shades: Sberbank now has “green, which is Pantone 349”, MTS has “red, Pantone 485”, and Gazprom has “blue, Pantone 300CV”.

15 January 2016

Cross-Border Loans: Assignment Ban Lifted, New Hurdles Imposed

Effective as of 1 January 2016, the National Bank of Ukraine (the “NBU”) adopted Resolution dated 30 December 2015 No. 996 (“Resolution 996”) introducing certain amendments to the procedure of registration of cross-border loans raised by Ukrainian borrowers.

24 December 2015

Russian Arbitration Reform: Key Provisions

On 29 December 2015, the Russian President signed the Federal Law “On Arbitration in the Russian Federation” (“The Law on Arbitration”) and Federal Law “On Amendments to Certain Laws of the Russian Federation…” providing for fundamental reform of domestic arbitration.

23 December 2015

Ukraine facilitates property and other registrations

On December 13, 2015, new legislation introducing a number of substantial novelties in the property registration system in Ukraine (the “New Law”) entered into force. Although already modernized in the past years, property registrations have been often seen as the area of typical bureaucracy and transparency issues. As briefly summarized below, the changes proposed in the New Law are generally aimed at facilitation of property registrations by ensuring higher accessibility of registrations.

8 December 2015

The NBU Reinforces FX Restrictions

The National Bank of Ukraine (the “NBU”) has adopted resolution No.863 dated 4 December 2015 (“Resolution 863”) aimed at stabilisation of the situation on Ukrainian FX market.

9 November 2015

Ukrainian Ministry of Healthcare changes authorization process for medicinal products

With effect from 30 October 2015, a new order of the Ministry of Healthcare of Ukraine (the “Order”) introduced a number of significant changes to Ukrainian drug review and authorization process.

6 November 2015

Legal alert: Sovereign Immunity: Russia Adopts a Restrictive Approach on a Reciprocal Basis

On November 3, 2015, the President of the Russian Federation signed the Federal Law № 297-FZ on Jurisdictional Immunities of Foreign States and Property of Foreign States in the Russian Federation (the Law). The Law will take effect from January 1, 2016 (Art. 18). By passing the Law, Russia has endorsed the restrictive theory of sovereign immunity entirely, and ruled out the dichotomy which exists between the Code of Civil Procedure and the Code of Commercial Procedure.

23 October 2015

Legal alert: National Bank of Ukraine modified some of its FX Restrictions

The National Bank of Ukraine (the “NBU”) adopted Resolution No. 718 dated 22 October 2015 “On Introduction of Amendments to Resolution of the Management Board of the NBU dated 03 September 2015 No. 581” (the “Resolution 718”) which modified certain of the NBU’s restrictions introduced (or prolonged) in September 2015.

13 October 2015

EPAM Legal Highlights: Introducing Federal Law "On the Free Port of Vladivostok"

On October 12, 2015, Federal Law of July 13, 2015 No. 212-FZ “On the Free Port of Vladivostok” (the “Free Port Law”) entered into force.