{"title":"[1992-2020 年欧盟和美国药品交易监管的发展。报告 2.1992-2001 年欧盟药品交易规范性法律基础的发展]。","authors":"E A Volskaya","doi":"10.32687/0869-866X-2024-32-4-762-771","DOIUrl":null,"url":null,"abstract":"<p><p>The article continues to consider problem of regulation of pharmaceuticals turn-over in the EU and the USA in 1992-2020. The history of development of European pharmaceutical legislation in 1992-2001 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>","PeriodicalId":35946,"journal":{"name":"Problemy sotsial''noi gigieny i istoriia meditsiny / NII sotsial''noi gigieny, ekonomiki i upravleniia zdravookhraneniem im. N.A. Semashko RAMN, AO ''Assotsiatsiia ''Meditsinskaia literatura''","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"[The 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 1992-2001].\",\"authors\":\"E A Volskaya\",\"doi\":\"10.32687/0869-866X-2024-32-4-762-771\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>The article continues to consider problem of regulation of pharmaceuticals turn-over in the EU and the USA in 1992-2020. The history of development of European pharmaceutical legislation in 1992-2001 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>\",\"PeriodicalId\":35946,\"journal\":{\"name\":\"Problemy sotsial''noi gigieny i istoriia meditsiny / NII sotsial''noi gigieny, ekonomiki i upravleniia zdravookhraneniem im. N.A. Semashko RAMN, AO ''Assotsiatsiia ''Meditsinskaia literatura''\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-07-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Problemy sotsial''noi gigieny i istoriia meditsiny / NII sotsial''noi gigieny, ekonomiki i upravleniia zdravookhraneniem im. N.A. Semashko RAMN, AO ''Assotsiatsiia ''Meditsinskaia literatura''\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.32687/0869-866X-2024-32-4-762-771\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Problemy sotsial''noi gigieny i istoriia meditsiny / NII sotsial''noi gigieny, ekonomiki i upravleniia zdravookhraneniem im. N.A. Semashko RAMN, AO ''Assotsiatsiia ''Meditsinskaia literatura''","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.32687/0869-866X-2024-32-4-762-771","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"Medicine","Score":null,"Total":0}
[The 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 1992-2001].
The article continues to consider problem of regulation of pharmaceuticals turn-over in the EU and the USA in 1992-2020. The history of development of European pharmaceutical legislation in 1992-2001 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.
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