Implications of the portal for the surveillance of cosmetic products

The AEMPS (Spanish Agency of Medicines and Health Products) has launched a portal for the surveillance of cosmetic products, which allows professionals in the cosmetic and health sector, distributors and citizens in general to report any negative or undesirable effects observed in a cosmetic product.

Alejandro Alonso Dregi, partner in the commercial area, explains how it works and its implications in his article for the Revista VPC: "The "Cosmetovigilance" system is one of the pillars in the fight against the marketing of products that do not meet the minimum conditions of safety and hygiene for users". And it adds about its usefulness: "to collect, record, evaluate and monitor all undesirable effects, in order to know their nature and frequency, thus being able to take the necessary measures to prevent their occurrence, reduce their incidence and protect public health".

Our commercial lawyer comments on the launch of this cosmetic vigilance portal: "the Spanish Cosmetovigilance System (SECV) is undoubtedly one of the most effective and benchmark at European level. In fact, Spain is one of the few EU countries that imposes on healthcare professionals (since February 28, 2018, that is, since the publication in the Official State Gazette of Royal Decree 85/2018, of February 23, regulating cosmetic products) the notification of serious cases of unwanted effects produced by cosmetic products, in accordance with Article 10 of the referred Royal Decree".

Alonso Dregi concludes that the cosmetic product surveillance portal (called NotificaCS) is therefore "a tool that will make it easier for the cosmetic product manager to properly comply with its obligations, with efficiency and immediacy, thus transmitting confidence to the market and anticipating situations that can lead to reputational damage, sometimes irreversible if appropriate measures are not taken in time".