New amendments to the packaging waste legislation were promulgated in the 100th issue of the Bulgarian State Gazette dated 16 December 2022. The amendments are in the Ordinance on Packaging and Packaging Waste (the "Ordinance") and are officially in force as of 20 December 2022.

As early as 25 June 2023, legislation should come into force in the Czech Republic that could give consumers another powerful weapon in the battle against unfair business practices. This legislation introduces the so-called class action lawsuit, which will allow multiple victims, each typically holding small claims, to join together for united representation in court proceedings.

The Albanian Government is considering to impose an extraordinary payment for energy companies with regard to the profits that they have been realized due to the spike of energy prices caused by the ongoing war in Ukraine.

The year 2023 in Romania started with hopes for more legislative clarity concerning fire safety. Order No. 180 / 2022 issued by the Ministry of Internal Affairs for the Approval of the Methodological Norms on Fire Safety and Civil Protection Endorsements and Approvals (the “Fire Safety Norms”) was published in the Official Gazette of Romania on 27 December 2022.

The entire concept of golden shares can be explained in one sentence: golden shares make the adoption of certain corporate measures as well as decisions on amending certain provisions of the articles of association of a company dependent on the “yes” vote of the holder(s) of the golden shares.

Would you ever want to see digitally, Istanbul waking up to a rainy and gloomy day, an alien race that came to visit our species from a galaxy billion light year away, New York City under the post-apocalyptic acid rain, a peanut with a micro-scale civilization on it, the realistic portraits of people who actually never existed and no matter how far you go in the horizons of your imagination, a concrete and visual reflection of all your ideas?

On 26 January 2023, the Resolution of the Cabinet of Ministers of Ukraine "On Amendments to the Procedure for Investigation and Recording of Accidents, Occupational Diseases and Industrial Accidents" No. 59, dated 20 January 2023, (the "Resolution") came into effect. The Resolution, among other things, establishes the procedure for the timely and thorough investigation of workplace accidents caused by the military aggression of the russian federation against Ukraine.

The Corporate Sustainability Reporting Directive (CSRD) took effect on 5 January 2023. This directive amends the Non-Financial Reporting Directive of 2014 (NFRD) and introduces more detailed requirements for non-financial reporting in the area of ESG.

On 27 January 2023, after more than a year of delay, the Bulgarian parliament adopted Act on the protection of persons who report breaches ("Whistleblowing Act"). The Whistleblowing Act finally transposes the Whistleblowing Directive (Directive (EU) 2019/1937) beyond the deadline of 17 December 2021 for all member states. The Whistleblowing Act enters into force within 3 months as from its publication in the State Gazette, which was made on 2 February 2023.

It’s time to use the RRF for the promotion of energy storage in the CEE region.

Ministry of Mining and Energy published on 21st January, long awaited draft of the Amendments to the Renewable Energy Sources Act (RESA) with purpose to push forward further investments in RES sector by creating better legal framework for development of new projects.

Ukraine’s approach towards the circulation of cannabis has traditionally been strict: the cannabis market in Ukraine is not legalized, and the circulation of both cannabis itself and cannabinoids is generally prohibited. Both the Criminal Code of Ukraine and the Code of Administrative Offences of Ukraine provide for liability for illegal sowing or cultivation, manufacture, acquisition, storage, transportation, or shipment of cannabis.

In this article, we will review some long-awaited changes in Bulgarian legislation, as well as one particularly interesting precedent from the Supreme Court of Cassation case law. These were the highlights of autumn 2022 and we expect them to influence the development of national legislation in the field of healthcare/life sciences and consumer protection.

The “digitalization” buzzword can easily be found in the 21st century’s most-frequently-used vocabulary section. Something all businesses aspire to, digitalization can, depending on the specific area, represent a multitude of things, always being an inexhaustible power drive on a journey towards a modernized and efficient business playground.

The Romanian pharmaceutical sector has been constantly subject to legislative amendments and also scrutiny by numerous (tax, competition, criminal, regulatory) authorities. The base law on the healthcare system alone was modified more than 170 times in 16 years. While each authority has dealt with its own matters when regulating this sector, one of the main shortcomings is the lack of an integrated approach that, to the benefit of Romanian patients, looks holistically at aspects from clinical trials to pricing and reimbursement and claw-back tax.

A new trend is emerging in the National Institute of Pharmacy and Nutrition’s (OGYEI) recent case law on medicinal product promotion in Hungary. The OGYEI is more active, imposes higher fines, and its investigations extend to longer time periods and to a variety of promotional practices of pharma companies, instead of focusing on specific infringements as before. In numbers, the OGYEI published two to three times as many decisions annually in the past two years than before. Further, the imposed fines regularly exceed USD 75,000 and, in 2022, the OGYEI imposed its highest fine (approximately USD 100,000) in the last ten years.

Medical device manufacturers, importers, and distributors are advised to prepare for an important change in European and Polish laws on advertising for medical devices. Manufacturers do not always properly supervise their distributors in creating or revising promotional materials. This lack of oversight can lead to unexpected regulatory problems, especially under recent legal amendments. Preventive measures can help companies to avoid these problems.

The total consumption of medicines increased by 5% in 2021 compared to 2020. In financial terms, that is an increase of HRK 9.88 billion (or 17.4%) compared to 2020. Prescription-only medicines accounted for 92.9% of all consumption, while over-the-counter products accounted for 7.1%.