{"id":35663,"date":"2026-05-28T11:39:12","date_gmt":"2026-05-28T09:39:12","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=35663"},"modified":"2026-05-28T11:41:22","modified_gmt":"2026-05-28T09:41:22","slug":"injectable-fillers-clarifications-from-the-italian-ministry-of-health-on-intended-users-and-distribution","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/en\/2026\/05\/28\/injectable-fillers-clarifications-from-the-italian-ministry-of-health-on-intended-users-and-distribution\/","title":{"rendered":"Injectable Fillers: Clarifications from the Italian Ministry of Health on Intended Users and Distribution"},"content":{"rendered":"

On May 11, 2026, the Italian Ministry of Health published a Circular<\/a> clarifying the distribution and sales modalities of injectable fillers<\/strong>, both resorbable and non-resorbable, intended for professional use.<\/strong><\/p>\n

The communication follows reports submitted to the Directorate-General for Medical Devices and Pharmaceutical Services. The Circular aims to prevent and limit improper use of aesthetic medical devices<\/strong>, also considering that these products may be sold through online channels, pharmacies, and para-pharmacies.<\/strong><\/p>\n

MDR and intended use<\/strong><\/h3>\n

The Circular recalls that injectable fillers<\/strong> fall within the scope of Regulation (EU) 2017\/745 on medical devices (MDR)<\/strong>. Therefore, fillers may only be placed on the market if they comply with the General Safety and Performance Requirements and only when used in accordance with the intended purpose<\/strong> defined by the manufacturers (Art. 5 MDR).<\/strong><\/p>\n

The Ministry reiterates that injectable fillers are devices intended exclusively for professional use<\/strong>, excluding self-administration. Consequently, their distribution must be organized consistently with this intended purpose, ensuring that injectable fillers do not become freely accessible to the general public<\/strong>.<\/p>\n

As a result, any distribution model allowing direct access to fillers by non-qualified individuals is not compliant<\/strong>, as it is not consistent with the principle of intended use under the European Regulation.<\/p>\n

Supply chain verification obligations<\/strong><\/h3>\n

The communication refers to Article 14 of Regulation (EU) 2017\/745<\/strong>, which requires distributors<\/strong> to verify that the device is supplied in compliance with the conditions established by the manufacturer, including those relating to intended users.<\/p>\n

Accordingly, as specified in the Circular, pharmacies, para-pharmacies, distributors<\/strong>, and e-commerce operators<\/strong> are required to verify <\/strong>that devices are supplied in compliance with the conditions established by the manufacturer<\/strong>, including those relating to intended users and intended purpose.<\/strong><\/p>\n

Sales must therefore not be structured in a way that makes fillers directly accessible to individuals lacking the necessary professional qualifications.<\/p>\n

In practice, this means that distributors must ensure and verify that fillers are not accessible to the unqualified general public.<\/strong><\/p>\n

Reference to AIFA and public health protection<\/strong><\/h3>\n

The Circular also refers to the information note issued by the Italian Medicines Agency (AIFA) on September 8, 2023<\/strong>, which had already highlighted the public health risks associated with improper use of fillers <\/strong>and reiterated that aesthetic medicine procedures must be performed exclusively by licensed physicians with specific professional expertise.<\/p>\n

The Ministry is therefore acting to strengthen public health protection and prevent non-compliant use of devices requiring specific professional competence.<\/p>\n

>>> Complife team supports companies in the medical and aesthetic sector in placing products on the market in Italy, Europe, and worldwide, in full regulatory compliance.<\/p>\n

SOURCE:
\nhttps:\/\/www.salute.gov.it\/new\/it\/news-e-media\/notizie\/filler-ad-uso-iniettivo-chiarimenti-su-modalita-di-distribuzione-e-vendita\/<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

On May 11, 2026, the Italian Ministry of Health published a Circular clarifying the distribution and sales modalities of injectable fillers, […]<\/p>\n","protected":false},"author":115,"featured_media":35668,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-35663","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en"],"acf":[],"yoast_head":"\nInjectable Fillers: Clarifications from the Italian Ministry of Health on Intended Users and Distribution - Thema Med<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"http:\/\/www.thema-med.com\/en\/2026\/05\/28\/injectable-fillers-clarifications-from-the-italian-ministry-of-health-on-intended-users-and-distribution\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Injectable Fillers: Clarifications from the Italian Ministry of Health on Intended Users and Distribution - 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