On May 26, 2021, the EU’s new Medical Device Regulation came into force, significantly changing the applicable regime, including – of particular interest to the dynamic Slovenian MedTech start-up community – by providing a new definition of software applications that need to be certified as medical devices.
Managed Entry Agreements consist of various forms of confidential arrangements between pharmaceutical companies and paying healthcare systems that aim to facilitate access to new technologies in public healthcare systems. MEAs make innovative and costly medicines or medical technologies affordable to patients by providing conditional access to a reimbursement system for a limited period and on balanced terms.
We are now one year on from the first lockdown, and although many worried in the early days of the pandemic that Romania’s court system might not be able to cope with the large number of insolvencies that were expected, in fact the highly-anticipated wave of restructurings is yet to happen, as the debt moratorium which was enacted and then extended and the availability of the state aid package as well as the generally supportive approach of the lenders have helped companies manage their debt service and need for liquidity. While there is no shortage of funding, the uncertainty of the lockdown period and its impact on future developments have resulted in more amend-and-increase or amend-and-extend transactions, with borrowers adding to their existing lender groups rather than seeking a full refinancing.
Economic, policy, and legislative factors have revived investors’ interest in Romania’s renewables sector over the last year. As the second-largest market in Central and Eastern Europe, Romania managed to attract about EUR 8 billion in renewables investments in the first wave from 2008-2016 – mainly in solar (over 1.5 GW) and wind (over 3 GW) – benefitting from the green certificate support scheme, although Romania reached its 2020 target for green energy and investments slowed down significantly over the last five years.
Annual reports make up a fundamental part of many regional CEE law firms’ marketing strategies, providing those firms with an annual opportunity to demonstrate their knowledge and expertise in a particular area, their geographic footprints, and their ownership and facility with the research and technological tools and manpower necessary for the production of such comprehensive projects.
CMS has advised co-organizers and dealers Bank Polska Kasa Opieki S.A. and BNP Paribas Bank Polska S.A., securities dealer ING Bank Slaski S.A., and securities administrator mBank S.A. on a bond issue program for InPost at a total maximum nominal value of PLN 1 billion, as well as the first issue of bonds.