The Interpretation of EU States National Legislation Through the Lens of EU Directives

Dan Degan, Lawyer Romania and Adriatic Region, Viatris

If, in the initial legislative stages of the European Coal and Steel Community the decisions addressed directly to the enterprises that activated in this field were the most used instruments, to a later stage, around the 60s – 70s a lot more attention was devoted to regulations; a third phase, begun in the 80s until the late 90s brought to the fore the directive, as an indispensable instrument of the Community law. Of course, to reach this status the directive was considered, by its very nature, a decision addressed to the Member States , therefore an individual measure and not as a rule of general application.

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Romania Regulation General March 2023 Vol.16, No. 62, Winter 2023

Dan Degan

Dan Degan is an experienced Legal and Compliance professional, currently employed with Viatris in Bucharest, Romania. He has over 20 years of experience in the field and has held positions in companies like Amgen, Abbott and Novartis. Dan holds a LLM in Law from the University of Leicester (University), School of Law, a Post-graduation Degree in Legal Counselling and Business Management from "Petru Maior" University, Romania, and a University Degree in English and Romanian Philology from "Petru Maior" University, Romania.

Viatris

Viatris is headquartered in the United States, with three global centers in Pittsburgh, Pennsylvania, U.S., Shanghai, China, and Hyderabad, India. Viatris operates approximately 40 manufacturing facilities, which produce complex dosage forms, injectables, oral solid doses and active pharmaceutical ingredients. In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life (https://www.viatris.com/en/about-us).

Romania Regulation General March 2023 Vol.16, No. 62, Winter 2023