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Revista de la OFIL

versão On-line ISSN 1699-714Xversão impressa ISSN 1131-9429

Resumo

MADURGA-SANZ, M. Cosmetovigilance, the last vigilance?. Rev. OFIL·ILAPHAR [online]. 2023, vol.33, n.3, pp.284-288.  Epub 28-Fev-2024. ISSN 1699-714X.  https://dx.doi.org/10.4321/s1699-714x2023000300012.

Recently, the Spanish Agency for Medicines and Health Products (AEMPS, for its acronym in Spanish) has launched an app for the spontaneous reporting of unwanted effects associated with the use of cosmetics. It allows reporting by each type of professional who uses these cosmetic products, by healthcare professionals who can identify these unwanted effects or adverse reactions, and by the citizens themselves who use them daily. This tool, "NotificaCS", allows the application of the European cosmetovigilance regulation, which came into force since 2013. As well as it facilitates the spontaneous reporting of these effects through the Spanish Cosmetovigilance System (SECV, for its acronym in Spanish), created by decree of 2018. The Spanish and European regulations for cosmetic products are reviewed. Another example of the collaborative work of the 27 member states of the European Union. It also describes the similarities with the surveillance of other products, from medicines to medical devices, biocides and personal care products. All of them different, but similar in their regulation, and in their surveillance, with tools like the NotificaRAM app, used for more than 10 years. One more surveillance of products that are for health or can affect health. And ultimately, while waiting for Nutrivigilance, which must be launched to monitor the effects of functional foods, nutraceuticals, dietetics, or food supplements that, it is known, can have pharmacological effects, directly or through drug interactions, that affect health.

Palavras-chave : Cosmetics; cosmetovigilance; nutrivigilance; pharmacovigilance; European Union.

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