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      Garantías y uso racional de los medicamentos, productos sanitarios, productos cosméticos y productos de higiene personal en las Fuerzas Armadas del Estado Español: análisis del Real Decreto 1155/2020, de 22 de diciembre Translated title: Guarantees and rational use of medicines, health products, cosmetic products and personal hygiene products in the Armed Forces of the Spanish State: analysis of Real Decreto 1155/2020, of December 22

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          Abstract

          RESUMEN: Los medicamentos, productos sanitarios, productos cosméticos y productos de higiene personal se ven sometidos a un régimen jurídico específico debido a su trascendencia sanitaria. Estos bienes son requeridos para las Fuerzas Armadas para el cumplimiento de las funciones que se les han asignado reglamentariamente, motivo por el cual, se ha aunado en una disposición normativa -de rango reglamentario- las peculiaridades relativas a su uso racional y garantías sanitarias, que son analizadas en el presente trabajo. Se establecen trascendentes requerimientos normativos, entre ellos, el registro de los elaborados farmacéuticos del Petitorio, la adecuación a la normativa vigente en materia de fabricación, distribución, farmacovigilancia, investigación clínica, etc. de estos productos en un plazo no superior a los cinco años. Se refuerza el régimen de incompatibilidades del personal militar, la figura de director técnico farmacéutico en el ámbito de la distribución. Asimismo, se clarifica la adopción de medidas cautelares.

          Translated abstract

          ABSTRACT: Medicines, health products, cosmetics and personal hygiene products are subject to a specific legal regime due to their health significance. These assets are required by the Armed Forces for the fulfillment of the functions that have been assigned to them by regulation, which is why the peculiarities related to their rational use and sanitary guarantees have been combined in a normative provision -Royal Decree- are analyzed in the present work. Transcendent regulatory requirements are established, among them, the registration of the pharmaceutical products of the ‘Petitory’, the adaptation to the current regulations on manufacturing, distribution, pharmacovigilance, clinical research, etc. of these products in a period not exceeding five years. The regime of incompatibilities of military personnel, the figure of pharmaceutical technical director in the field of distribution, is reinforced. Likewise, the adoption of precautionary measures is clarified.

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          El medicamento de fabricación industrial en la España contemporánea

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            Historia de la Farmacia

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              Páginas de historia de la farmacia

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                Author and article information

                Journal
                sm
                Sanidad Militar
                Sanid. Mil.
                Ministerio de Defensa (Madrid, Madrid, Spain )
                1887-8571
                December 2021
                : 77
                : 4
                : 229-232
                Affiliations
                [1] Madrid orgnameUniversidad Complutense de Madrid, orgdiv1Facultad de Farmacia orgdiv2Departamento de Farmacia Galénica y Tecnología Alimentaria
                Article
                S1887-85712021000400229 S1887-8571(21)07700400229
                10.4321/s1887-857120210004000011
                113f279b-c244-4078-9973-babddc48ae08

                http://creativecommons.org/licenses/by/4.0/

                History
                : 28 September 2021
                : 20 July 2021
                Page count
                Figures: 0, Tables: 0, Equations: 0, References: 10, Pages: 4
                Product

                SciELO Spain

                Categories
                Informe

                buenas prácticas de distribución,clinical trials,pharmacovigilance,good distribution practices,good manufacturing practices,Military Pharmacy,Pharmaceutical Legislation,ensayos clínicos,farmacovigilancia,normas de correcta fabricación,Farmacia Militar,Legislación Farmacéutica

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