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[西班牙社区药房更年期食品补充剂法律框架分析]

[Analysis of the legal framework on food supplements for menopause in Spanish community pharmacies].

作者信息

Rubio Rubio Francisco Ignacio, Cabezas López María Dolores, Valverde Merino María Isabel, Martínez Martínez Fernando, Zarzuelo Romero María José

机构信息

Grupo de Investigación Atención Farmacéutica, Facultad de Farmacia, Universidad de Granada, Granada, España.

Grupo de Investigación Atención Farmacéutica, Facultad de Farmacia, Universidad de Granada, Granada, España.

出版信息

Gac Sanit. 2023 Feb 15;37:102290. doi: 10.1016/j.gaceta.2023.102290. eCollection 2023.

Abstract

OBJECTIVE

To analyze the legal framework for the marketing of specific food supplements prescribed and indicated for menopause symptoms, so that it is verified if according to the effects on health that they produce, should be considered in the category of food supplements, or in others included in our legal system.

METHOD

An exhaustive review of the legal frameworks applicable to food supplements used both in Spain and in Europe, collecting those aspects that are related to legal concepts such as the definition of medicine for human use, medicine based on medicinal plants, or the so-called "frontier products".

RESULTS

There is a large number of products that can be called "frontier products", they can fit into different product categories, they can fit into different product categories, since some of the plants in their formulation are also authorized for use as industrial medicines or medicines based on traditional medicinal plants.

CONCLUSIONS

There are currently specific food supplements for menopause that raise reasonable doubts about their inclusion in other legal categories, both as medicines for human use, or as herbal medicines, so the legislator would need to enable more agile mechanisms and more frequent reviews of the new certainties that science finds, and that can change the status of these products.

摘要

目的

分析针对更年期症状所开具和标明的特定食品补充剂的营销法律框架,以便核实根据其对健康产生的影响,它们应被归类为食品补充剂类别,还是应被纳入我国法律体系中的其他类别。

方法

详尽审查西班牙和欧洲适用的食品补充剂法律框架,收集与人类用药品、基于药用植物的药品或所谓“边缘产品”等法律概念相关的方面。

结果

有大量产品可被称为“边缘产品”,它们可归入不同的产品类别,因为其配方中的一些植物也被批准用作工业药品或基于传统药用植物的药品。

结论

目前有针对更年期的特定食品补充剂,对于将它们归入人类用药品或草药等其他法律类别存在合理疑问,因此立法者需要建立更灵活的机制,并更频繁地审查科学发现的新情况,这些新情况可能改变这些产品的地位。

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