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In general, a medicinal product can be placed on the Bulgarian market after obtaining a marketing authorisation / certificate for registration issued under the Bulgarian Medicinal Products in Human Medicine Act or after completing the "centralised procedure" under Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency ("Regulation 726/2004").

The European Union is committed to the fight against climate change ("European Green Deal"). One of the pillars in this fight is the expansion of renewable energy sources. According to the current goals, the share of renewable energy sources within the Union should increase to 32% by 2030. In practice, however, the expansion of renewable energy is increasingly being slowed down by the interpretation of EU nature conservation regulations by the European Court of Justice ("ECJ"). Also, the latest decision of the ECJ is no "boost" for renewables. 

Concern around carbon footprints, climate change, greenhouse emissions and compliance with environmental regulations and anti-bribery and corruption legislation has been on the rise over the last 20 years. More recently, that concern has expanded to encompass an increased emphasis on sustainable development in business operations and supply chains. The drive for more accountability and transparency from financial institutions, private equity investors and governments around the globe has turned the spotlight on disparities in terms of pay, gender and diversity, as well as the use of slavery in manufacturing. What started as discrete areas of focus and/or regulation, now firmly fall under the mainstream umbrella term, “Environmental, Social and Governance” (“ESG”).

The Serbian government has continued to upgrade the legal framework for granting State aid, having recently adopted a Regional State Aid Regulation. A new State Aid Control Act has been in force in Serbia since early 2020 and the process of harmonising bylaws with the new law is underway.

On the 30th of July 2020, or more precisely the 1st of January 2021, a long-awaited amendment to the Labor Code will come into force. Its aim is among others to facilitate the enforcement of employees’ rights, to facilitate communication between the employer and employee, to increase the flexibility of working processes or, for instance, to reduce the administrative burden of some obligations placed on the employer. The Labor Code amendment reflects a wide range of practical problems and regulates a wide range of important institutions. In this short summary, we will discuss the most significant changes that will be brought about by the amendment.

On June 20, 2019, the European Parliament and the Council of the European Union adopted the Directive (EU) 2019/1023 on restructuring and insolvency (hereinafter: Directive). The objectives of the Directive are to make it easier for companies in financial difficulty to access restructuring measures at an early stage to prevent them from becoming insolvent, to lay down minimal rules on the discharge of debt incurred by insolvent entrepreneurs and to increase the efficiency of preventive procedures and insolvency procedures, primarily to shorten the length of the procedures.

For our Checking In feature, we reach out to partners and heads of practice across CEE to learn how specific practice areas are faring in their jurisdictions. This time around we asked Data Protection experts: Overall, how compliant would you say economic agents are with relevant local regulations on data protection, and what are the main gaps that have yet to be addressed?

Cloud solutions have proven to be cost-efficient, productive and flexible for any business sphere. Technically, they are not intended for downloading by users, as users only get access to certain functions. Still, sometimes download option is available. Hence a question: which type of agreement works better between a cloud provider and users, i.e. license, service or hybrid?

According to a Government Decree passed on 9 February 2021, lessees do not have to pay rent for a property owned by the Hungarian State or the local municipality (or by companies which are controlled by these) for the specified five-month period (February - June 2021). The decree specifies a list of 25 types of activities which are to be alleviated from paying rent, which includes:

Growing industrial cannabis as a business activity in the Republic of Serbia is not a new phenomenon. The act that specifically regulates this area is the Law on Psychoactive Controlled Substances adopted in 2010 with its amendments in 2018 (“Law”). Besides the aforementioned Law, the Rulebook on Growing Industrial Cannabis adopted in 2013 (“Rulebook”) regulates it in more depth, meaning the business of growing industrial cannabis has been in the books for around a decade.

The European Commission has presented a proposal for two regulations that aim to harmonize the rules of the digital space in the European Union. The first regulation called the Digital Services Act focuses on the regulation of digital services of all kinds, and primarily protects the recipient of the services from illegal content, infringement of their consumer rights, and other risks.

In February 2021 the State Secretary of Labour of the Ministry for Innovation and Technology announced a new measure to fight black employment. The amendment of the Act on the Service and Support to Subserve the Employment, and on the Supervisory of Employment (Act) is already in effect since 1 March 2021.

Stock incentive schemes granted by listed or unlisted companies such as s stock options, stock appreciation, restricted shares and stock awards are a common way of rewarding employees. Employees participating in stock incentive schemes are subject to individual income tax.

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