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Life sciences in Romania, encompassing pharmaceuticals, biotechnology, and medical devices, is a sector marked by both significant challenges and promising opportunities. As the country continues to integrate into the European Union’s regulatory and economic frameworks and as those frameworks evolve and become more complex, Romania faces the constant task of aligning its local industry with European and international standards. This alignment is crucial for fostering innovation, ensuring public health, and attracting foreign investment. The industry’s growth is influenced by many factors, such as financing, pricing and reimbursement, regulatory compliance and product liability, and sustainable public procurement tools and processes.

The European Public Prosecutor’s Office (EPPO) is an independent body of the European Union (EU) tasked with investigating criminal cases infringing the financial interests of the EU. The EPPO was formally established in 2017 and started operations in 2021. The first and current head of the European Chief Prosecutor is Laura Codruta Kovesi, former Chief Prosecutor of the National Anticorruption Directorate (Directia Nationala Anticoruptie; DNA), the Romanian agency tasked with investigating corruption cases.

In The Debrief, our Practice Leaders across CEE share updates on recent and upcoming legislation, consider the impact of recent court decisions, showcase landmark projects, and keep our readers apprised of the latest developments impacting their respective practice areas.

The Romanian Parliament has recently passed a new piece of legislation (“Law 124/2024”) allowing local authorities to extend until 31 December 2026 the validity term of the general urbanism plans (in Romanian: “planuri de urbanism generale” or “PUG”), which were drawn up and approved before 2003. Law 124/2024 entered into force on 10 May 2024 and approved Government Ordinance no. 33/2023 regarding the prolongation of certain validity terms in the urbanism and construction field (“GO 33/2023”).

The Romanian Energy Regulator (ANRE) recently published a proposal for a new procedure regarding the passporting in Romania of energy or natural gas supply and trading licenses issued in other EU countries, based on ANRE’s confirmatory decisions (New Passporting Procedure).

Former Tuca, Zbarcea si Asociatii Lawyers Mihai Dudoiu and Sergiu Negreanu have opened a new boutique law firm: Dudoiu, Negreanu & Associates – operating under the brand Legal.Ground.

Clifford Chance Badea has advised Premier Energy on its IPO and listing on the Bucharest Stock Exchange amounting to approximately RON 700 million. Dentons advised the bookrunners. Moldova's Turcan Cazac and Cyprus' Chrysses Demetriades & Co reportedly advised the bookrunners as well.

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. For this piece, we asked firm Labor experts:  Have whistleblowing regulations been implemented in your jurisdiction and would you advise companies to use an external solution or an in-house one? Why?

Filip & Company has advised Romania's RCS & RDS on signing two export credit facility agreements totaling EUR 117.16 million for the acquisition of goods and services to develop its telecom networks in Romania and Portugal and advised its Digi Spain Telecom subsidiary on a EUR 50 million uncommitted and unsecured credit facility agreement.

Romanian Knowledge Partner

Țuca Zbârcea & Asociații is a full-service independent law firm, employing cross-disciplinary teams of lawyers, insolvency practitioners, tax consultants, IP counsellors, economists and staff members. It also operates a secondary law office in Cluj-Napoca (Romania), and has a ‘best-friend’ agreement with a leading law firm in the Republic of Moldova. In addition, thanks to the firm’s dedicated Foreign Desks, the team provides the full range of services to international investors seeking to gain a foothold or expand their existing operations in Romania. Since 2019, the firm and its tax arm are collaborating with Andersen Global in Romania.

Țuca Zbârcea & Asociaţii is providing legal services in every aspect of business, covering all major areas of practice: corporate and M&A; litigation and international arbitration; corporate tax; public procurement; TMT; employment; insurance; banking and finance; capital markets; competition; healthcare and pharmaceutical; energy and natural resources; environmental; intellectual property; real estate; regulatory legal services.

Țuca Zbârcea & Asociaţii is a First-Tier law firm in all international legal directories and a multiple award-winning law firm both locally and internationally. It received the CEE Deal of the Year Award (DOTY Awards 2021) and the Law Firm of the Year Award: Romania (IFLR Europe Awards 2021). 

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