Problems of Social Hygiene, Public Health and History of MedicineProblems of Social Hygiene, Public Health and History of Medicine0869-866X2412-2106Joint-Stock Company Chicot151410.32687/0869-866X-2024-32-4-772-777НеопределенThe development of regulation of pharmaceuticals turn-over in EU and the USA in 1992–2020. Report 2. Development of normative legal base of pharmaceuticals turn-over in EU in 1992–2001VolskayaE Avols-elena@yandex.ruN. A. Semashko National Research Institute of Public Health, 105064, Moscow, Russia170820243242504202525042025Copyright © 2025,2025<p>The article continues to consider problem of regulation of pharmaceuticals turn-over in the EU and the USA in 19922020. The history of development of European pharmaceutical legislation in 19922001 is considered. This stage is characterized by passing Directives (laws of indirect action) that were obligatory for implementation through their inclusion into national normative legal bases. In 2001 the passed laws were compiled into EU Pharmaceutical Code (Directive 2001/83) that regulates main sections of pharmaceuticals turn-over from their production to pharmaceutical control. The adoption of Code laid the foundation for EU legislation in the field of medications.</p>pharmaceutical marketEUmedicinal productpharmaceuticallegislationharmonizationregulationactivitiesdirectiveregulationsлекарственные средствафармацевтическое законодательствогармонизациярегулирование деятельностидирективарегламент[Federal Food, Drug, and Cosmetic Act. XML. Available at: https://www.govinfo.gov/content/pkg/COMPS-973/pdf/COMPS-973.pdf][Council Directive 92/25/EEC of 31 March 1992 on the wholesale distribution of medicinal products for human use. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A31992L0025][Council Directive 92/26/EEC of 31 March 1992 concerning the classification for the supply of medicinal products for human use. Available at: https://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX%3A31992L0026][Council Directive 92/27/EEC of 31 March 1992 on the labelling of medicinal products for human use and on package leaflets. Available at: https://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX%3A31992L0027][Council Directive 92/28/EEC of 31 March 1992 on the advertising of medicinal products for human use. Available at: https://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX%3A31992L0028][Kolipova Yu. Foreign Pharmaceutical Distribution. Development trends. Remedium. 2004;(1-2):42–6 (in Russian).][Volskaya E., Shashkova G. On the concept of information equilibrium. Remedium 2012;(1):14–7 (in Russian).][Shashkova G., Volskaya E. Development of legal regulation of information on medicinal products. Part 1. European experience. Remedium. 2004;(10):28–34 (in Russian).][Volskaya E., Klimanov M. On the Basics of Occupational Communications Protection in the Pharmaceutical Market. Remedium. 2012;(1):8–13 (in Russian).][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. Available at: https://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX%3A32001L0083][Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Available at: https://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX% 3A32001L0020][Case C-322/01. Reference to the Court under Article 234 EC by the Landgericht Frankfurt am Main (Germany) for a preliminary ruling in the proceedings pending before that court between Deutscher Apothekerverband eV and 0800 DocMorris NV. Available at: https://e-justice.europa.eu/caseDetails.do?plang=en&clang= fr&idTaxonomy=5665&idCountry=1][Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use. Available at: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0074:0099:EN:PDF][Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products. Available at: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=celex%3A32011L0062]