Thursday, October 9, 2014Authorities

ANSM : an update on cosmetovigilance

Télécharger le compte-rendu de la réunion du GT "Produits Cosmétiques" du 8 juillet 2014

The ANSM has just published the minutes of the last meeting of the WG"Cosmetic Products". On the menu: an assessment of vigilance, in terms of obligations and figures, in France and in Europe, with an initial review of cooperation between Member States 9 months after its implementation by the Cosmetics Regulation.

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The meeting of this working group was held on 8 July, but the minutes were not published until 6 October on the ANSM website. On the agenda, mainly, a complete overview on the vigilance of cosmetics and tattoo products.

Vigilance

The session began with a presentation of vigilance by two representatives of the Directorate of Legal and Regulatory Affairs of the ANSM. They recalled the legislative framework (European Cosmetics Regulation 1223/2009 and French DDADUE law 2014-201), the key definitions and obligations of the various stakeholders (responsible persons, distributors, health professionals) in terms of reporting serious adverse reactions as well as the penalties applicable to them in the event of breaches. They also recalled the possibility for end-users (professional users and consumers) to report directly any adverse reactions. The obligations of national competent authorities with regard to the management and reporting of serious adverse reactions throughout the European Union were also mentioned.

Assessment of French cosmetovigilance 2013

In a second stage, the ANSM presented the latest cosmetovigilance figures. With 151 adverse reactions (ARs) reported over one year, the trend remains stable but the numbers could increase again in 2014 (100 incidents had already been reported at the end of June).

In …

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