Out of focus: EC proposals for changes in the European pharmaceutical legislation that went unnoticed – Part II

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In the previous article, we reviewed in detail some of the proposals of the European Commission for a comprehensive overhaul of European pharmaceutical legislation, contained in the new draft Directive on the Union code relating to medicinal products for human use (the “Directive”) and in the draft Regulation laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency (the “Regulation”), which were not addressed by the Bulgarian media.

Tsvetkova Bebov & Partners, a member of Eversheds Sutherland was invited to be the exclusive country contributor to the CEE Legal Matters Comparative Legal Guide: Capital Markets 2023 for Bulgaria.

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The CEE Legal Matters Comparative Legal Guide: Capital Markets 2023 offers an overview of key requirements for equity and debt offerings across the CEE region. It is intended to provide a high-level overview of the regulatory and listing regime (including regulated and non-regulated markets) and the typical offering process for equity and debt securities in a concise and consistent format across the various jurisdictions. In addition, the guide highlights ongoing continuing obligations and a brief summary of ESG considerations applicable to issuers.

Out of focus: EC proposals for changes in the European pharmaceutical legislation that went unnoticed – Part I

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On 26 April 2023, the European Commission presented its long-awaited proposal for a comprehensive reform of the European pharmaceutical legislation. The reform aims to replace Directive 2001/83/EC on the Community code relating to medicinal products for human use with a new Directive (“the Directive”) and the integration into a new general regulation (“the Regulation”) of the Regulations establishing the European Medicines Agency and the centralised procedure for the authorisation of medicinal products (Regulation No 726/2004), orphan medicinal products (Regulation No 141/2000), advanced therapy medicinal products (Regulation No 1394/2007) and medicinal products for paediatric use (Regulation No 1901/2006).

Digitalization of the order for payment procedure

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In the beginning of February 2023, amendments to the Civil Procedure Code (“CPC”), dedicated to the digitalization of the order for payment procedure were promulgated. In the motives of the draft law, it is noted that the changes are in line with the tendency in the European Union towards the digitalization of this procedure, as well as with the aim of allocating judicial resources in a more optimal way through the centralized distribution of the order for payment procedures among regional judges across the country.

Changes in the regime for admission of citizens of third countries for the purposes of highly qualified employment in Bulgaria

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On January 25, 2023, was promulgated an Act to Amend and Supplement the Labor Migration and Labor Mobility Act (“AAS the LMLMA”), adopted by the 48th National Assembly on January 19, 2023. The changes concern the conditions for entry and residence of citizens of countries outside the European Union (“EU”) on the territory of the Republic of Bulgaria for the purposes of highly qualified employment, as well as the procedure for issuing a long-term residence and work permit of the “European Union Blue Card” type, which is regulated by the Foreigners in the Republic of Bulgaria Act (“FRBA”) and the regulations for its application.