Bulgaria: Duplicate marketing authorisation applications – during a pandemic, availability is all that matters

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.

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CEE legislation tracker: Hungary

Table of Contents 1 Financial Support Measures 2 Capital Markets 3 Employment 4 Real Estate & Construction 5 Tax & Duties 6 Corporate, M&A 7 EU & Competition 8 Courts and Authorities 9 Healthcare 10 Insolvency & Restructuring 11 Insurance 12 Intellectual Property 13 Telecom & Data Protection 14 Other

The role of energy communities in Austrian energy law

The legislative package relating to the Renewable Expansion Act (EAG package) contains the legal requirements for energy communities that, as new market participants, can make a significant contribution to the energy transition.

Employment Law Review – Austria

By Stefan Kühteubl and Martin Brandauer Employment law is extensively regulated by statutory mandatory law to ensure the protection of employees. Unlike in other countries, Austrian employment law is extremely fragmented and not codified in one single codex of law. Since Austria’s accession to the European Union in January 1995, EU law has played an […]

The deadlock in the sale of Romanian farmland located outside buildable areas continues

The end of 2020 and the beginning of this year have brought a lot of uncertainty to the sale of farmland located outside buildable areas. The uncertainty stems from the amendment of Law no. 17/2014 on the regulation of the sale-purchase of agricultural land situated outside buildable areas, and the amendment of Law no. 268/2001 on the privatisation of companies administrating the State’s publicly- and privately-owned land with an agricultural use, and for the creation of the Agency for the State’s Domain.

Latest Briefings

Romanian draft law on 5G technology under strong criticism from both public authorities and private stakeholders

The Draft law on the adoption of certain measures concerning informatic and communications infrastructures of national interest and the conditions for deployment of 5G networks initiated by the former Ministry of Transportation, Infrastructure and Communications has undergone a new series of examinations from the relevant public authorities as part of the legislative procedure.

Insurance Bulletin Spring 2021

Although the full impact of Covid-19 on the re/insurance industry remains unclear, the need to retain capital to meet potential losses has contributed to a general hardening of the market after 15 years of soft market conditions characterised by excess capacity, low prices and more relaxed policy terms.

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