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Gloss to the Judgment of the Court of Justice of the European Union (Third Chamber) of 25 November 2021 in Case C‑488/20, Delfarma SP. Z o.o. v. Prezes Urzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych

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Mełgieś K. M.
Review of European and Comparative Law
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2023
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vol. 55
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issue 4
279-292
EN
Medicinal products are a special type of goods due to their importance for human health and life, and their trade is generally under the scope of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. The preamble to this act states that the essential aim of the rules governing the production, distribution and use of medicinal products must be to safeguard public health. Hence, in the above-mentioned directive, the rules related to the authorisation of medicinal products for marketing and pharmacovigilance are very important. At the same time, it should be noted that parallel import of medicinal products as a form of trade in an EU Member State in connection with their authorisation for marketing in another Member State, although it has a long tradition, has not had a clear normative pattern, and has not been subject to the scope of Directive 2001/83/EC. It is based on the achievements of the acquis communautaire developed in this area and the principle of free movement of goods (Article 34 TFEU) and its exceptions set out in Article 36 TFEU concerning the protection of human health and life. The commented judgment sets an example of one more verdict confirming the interpretation of Articles 34 and 36 TFEU, according to which national provisions of a Member State should be considered unacceptable, according to which the withdrawal of the marketing authorisation for the reference medicinal product in the country of import has the automatic effect of expiring the parallel import authorisation. At the same time, new circumstances affecting the safety of the medicinal product on the market were analysed to give the conclusion as declared in the sentence.
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The Evolution of One Health concept – A European perspective

100%
Mełgieś K. M.
Review of European and Comparative Law
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2024
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vol. 57
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issue 2
7-29
EN
Over the past years, the European Union has been engaged in activities aimed at finding solutions to protect health in accordance with interdisciplinary and transdisciplinary thinking in line with the One Health approach. The experiences related to the Covid-19 pandemic, clearly demonstrated the close connection between humans, animals, and the shared environment and increased interest for this approach to be applied and translated into action. This paper seeks to present the readiness of the European Union and its institutions for the challenges related to the political and legal approach and implementation of One Health concept.
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