At the regulatory congress organized by the Cosmetic Valley in Chartres, France, in November 2016, Sophie Roques-Violin, Director of the Market Surveillance Inspection Department, and Vanessa Picot, Cosmetic Product Inspector, both at the ANSM (French National Agency for Medicines and Health Products Safety), made a presentation of their action and provided the results of the controls carried out on the cosmetics market over the year 2016.
Sophie Roques-Violin started by emphasizing the fact that supervisory authorities have always helped the industry anticipate regulatory changes. Proof of this, she said, ‘a few years ago, I spread the word to manufacturers to prepare the implementation of the new Regulation, and today’s ANSM actions are taken in the same spirit.’
Inspection Directorate and INSMAR Division
The Inspection Directorate (DI) represents one of the three major trades of the ANSM: assessment, inspection, and controls.
Sophie Roques-Violin reiterated its values:
• Impartiality: equity and harmonization of practices
• Transparency: publication of all the decisions made by the DI on the ANSM website
• Competence: accreditation programme for inspectors
• Rigor: guarantee of credibility
• Commitment: improving the practices that guarantee product quality and safety of health products and consumers
INSMAR Division
The INSMAR Division, for INspection in MARket Surveillance, takes action in three fields:
• Medical devices
• In vitro diagnostic medical devices
• Cosmetic and tattoo products
These three product types share a common point: they are not subject to the pre-market authorization, which, as Sophie Roques-Violin reminded, involves the responsibility of operators.
The missions of the INSMAR Division involve different areas of action:
• Inspections and their administrative consequences …
