Resumo

NOGUERA-PENA, A. 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. Sanid. Mil. [online]. 2021, vol.77, n.4, pp.229-232.  Epub 09-Maio-2022. ISSN 1887-8571.  https://dx.doi.org/10.4321/s1887-857120210004000011.

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.

Palavras-chave : Pharmaceutical Legislation; Military Pharmacy; good manufacturing practices; good distribution practices; pharmacovigilance; clinical trials.

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