Law Policy Management,, and Regulation of Health
Mehdi Moazzami goudarzi
Articles in Press, Accepted Manuscript, Available Online from 23 August 2025
Abstract
Background and objective: Cosmetovigilance is a recent concept. The term itself has just been indexed. It is a form of health public surveillance with a public health objective; it therefore differs from the surveillance carried out by industrialists, who aim at the safety of the product for commercial ...
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Background and objective: Cosmetovigilance is a recent concept. The term itself has just been indexed. It is a form of health public surveillance with a public health objective; it therefore differs from the surveillance carried out by industrialists, who aim at the safety of the product for commercial purposes, and differs from peer surveillance whose purpose is medical. Cosmetovigilance concerns cosmetic products. The 2006 European resolution has laid the ground work for a cosmetovigillance system based on case notifications. As of 2013, the new European regulation requires that serious undesirable effects reported to the competent authority should be transmitted to the competent authorities of the other Member States and to the person responsible for the cosmetic product. Two problems are yet to be solved: causality assessment and reporting categories. Result and discussion: Cosmetovigilance systems are genuine means of obtaining information on the safety of cosmetic products and their ingredients. They can be used by Europe to check that new directives ensure a high level of safety. Cosmetovigilance makes it possible to rule out or control potentially hazardous ingredients and can thus set our minds at ease about the products placed on the market. Until now, there is no act to design and establish local cosmetovigillance system from the side of official authority in IRAN
New Technologies Health and Law
Mehdi Moazzami Goudarzi
Abstract
Background and Objective: Cosmetovigilance is a recent concept. The term itself has just been indexed. It is a form of health public surveillance with a public health objective; it therefore differs from the surveillance carried out by industrialists, who aim at the safety of the product for commercial ...
Read More
Background and Objective: Cosmetovigilance is a recent concept. The term itself has just been indexed. It is a form of health public surveillance with a public health objective; it therefore differs from the surveillance carried out by industrialists, who aim at the safety of the product for commercial purposes, and differs from peer surveillance whose purpose is medical. Cosmetovigilance concerns cosmetic products. The 2006 European resolution has laid the ground work for a cosmetovigillance system based on case notifications. As of 2013, the new European regulation requires that serious undesirable effects reported to the competent authority should be transmitted to the competent authorities of the other Member States and to the person responsible for the cosmetic product. Two problems are yet to be solved: causality assessment and reporting categories. Methods: This applied research, conducted with an analytical-comparative approach, examines and compares the cosmetovigilance systems in Iran and the European Union from legal and executive perspectives. Data were collected through library and documentary studies and then extracted and compared using qualitative content analysis of key indicators. The temporal scope of the research extends from the implementation of European Regulation 1223/2009 to 2025, and the geographical scope includes Iran and the member states of the European Union.Conlusion: Cosmetovigilance systems are genuine means of obtaining information on the safety of cosmetic products and their ingredients. They can be used by Europe to check that new directives ensure a high level of safety. Cosmetovigilance makes it possible to rule out or control potentially hazardous ingredients and can thus set our minds at ease about the products placed on the market. Until now, there is no act to design and establish local cosmetovigillance system from the side of official authority in IRAN.
