Message 001
Communication from the Commission - TRIS/(2023) 3072
Directive (EU) 2015/1535
Notification: 2023/0619/FR
Notification of a draft text from a Member State
Notification – Notification – Notifzierung – Нотификация – Oznámení – Notifikation – Γνωστοποίηση – Notificación – Teavitamine – Ilmoitus – Obavijest – Bejelentés – Notifica – Pranešimas – Paziņojums – Notifika – Kennisgeving – Zawiadomienie – Notificação – Notificare – Oznámenie – Obvestilo – Anmälan – Fógra a thabhairt
Does not open the delays - N'ouvre pas de délai - Kein Fristbeginn - Не се предвижда период на прекъсване - Nezahajuje prodlení - Fristerne indledes ikke - Καμμία έναρξη προθεσμίας - No abre el plazo - Viivituste perioodi ei avata - Määräaika ei ala tästä - Ne otvara razdoblje kašnjenja - Nem nyitja meg a késéseket - Non fa decorrere la mora - Atidėjimai nepradedami - Atlikšanas laikposms nesākas - Ma jiftaħx il-perijodi ta’ dewmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Nu deschide perioadele de stagnare - Nezačína oneskorenia - Ne uvaja zamud - Inleder ingen frist - Ní osclaíonn sé na moilleanna
MSG: 20233072.EN
1. MSG 001 IND 2023 0619 FR EN 03-11-2023 FR NOTIF
2. France
3A. Direction générale des entreprises
SCIDE/PNRP
Bât. Sieyès -Teledoc 143
61, Bd Vincent Auriol
75703 PARIS Cedex 13
d9834.france@finances.gouv.fr
3B. Bureau des dispositifs médicaux et autres produits de santé
Sous-direction de la politique des produits de santé, de la qualité des pratiques et des soins
Direction générale de la santé
Ministère de la santé et de la prévention
14 avenue Duquesne, 75007PARIS
4. 2023/0619/FR - S10S - Medical devices
5. Decree on the supply of injectable hyaluronic acid
6. Hyaluronic acid-based devices
7.
8. The purpose of this text is to regulate the supply of medical devices and injectable hyaluronic acid-based products, in view of their serious risks to human health. It thus limits the supply of these products to doctors and dental surgeons for their professional use, or, on their prescription, to a patient.
In addition, it prohibits the online sale of these products, as well as their importation as part of an online sale, to individuals for reasons of public health. However, online sales are still possible for healthcare professionals authorised to give injections (doctors and dental surgeons).
In light of the prohibition of online sales and of importation as part of an online sale, a notification under Article 3(4) of Directive 2000/31 (e-Commerce Directive) will be given.
9. Hyaluronic acid-based injections, in that they affect the integrity of the human body, can only be performed by doctors or dental surgeons as part of therapeutic treatment for them. Otherwise, in accordance with Article L. 4161-1 of the Public Health Code, they constitute an illegal practice of medicine.
In recent months, the French authorities have observed, through professionals, associations or complaints, an increase in illegal injections for cosmetic purposes, by persons not qualified as doctors. These illegal injections proliferate mainly on social networks and especially among young adults but also minors. These injections are dangerous since they can induce serious side effects, even to the extent in particular of causing tissue necrosis.
In order to put an end to these fraudulent practices and to safeguard the health of patients or users, the Ministry of Health and Prevention wishes to restrict access to injectable hyaluronic acid-based devices currently accessible to all citizens, including online sales, by regulating the supply of these products.
10. References to basic texts: There are no reference texts
11. No
12.
13. No
14. No
15. No
16.
TBT aspects: No
SPS aspects: No
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European Commission
Contact point Directive (EU) 2015/1535
email: grow-dir2015-1535-central@ec.europa.eu
