Cosmetovigilance – Regulatory requirements & compliance through ARISg

With an increased focus on cosmetovigilance driven by regulatory agencies across countries, the safety departments need to understand the impact of these regulations, the general cosmetovigilance process and ensure compliance. Under the new EU Regulation (EC) No 1223/2009, cosmetic companies are required to have information clearly available to the Regulatory Authorities concerning their cosmetic products formulation as well as safety assessments of those products, derived from the reports received from Consumers, Health Care Professionals, Aesthetic Professionals, National Competent Authorities and the scientific literature. In the US, FDA cosmetovigilance monitors the safety of cosmetic products that are being marketed and acts on products that are established to be harmful to consumers when used as intended. The agency has a number of ways to monitor these products including Voluntary Cosmetic Registration Program (VCRP), Inspections, Product Surveys, Cosmetic Ingredient Review (CIR) expert panel and Reports from consumers and health care providers. In Japan, Article 7 of the Ministerial Ordinance on Good Vigilance Practice (GVP) for drugs, quasi-drugs, cosmetics, and medical devices (GVP Ordinance) stipulates the obligation of MAHs to collect safety information and its scope.

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