It is a document required filing with the Spanish Agency for Medicines and Health Products (AEMPS) for imports of cosmetics and personal care as well as perfumes.
This Statement of responsibility must be reflected all company data (name, address, contact, tax number ...) and also stores used for import and technical professional manager and responsible for controlling the whole process of such importation.
The Responsible Declaration replaces the sanitary import license in cosmetics, personal care products and perfumes, but not in the rest of sanitary products. Assuming with this a reduction in the processing times.
The procedure is simple: first the Responsible Declaration must be presented, the product is communicated to the European notification portal and it matters. Furthermore, if this is the first time that this product is imported, it is essential to carry out the subsequent safety study.
La notificación al portal debe realizarse por la persona responsable introduciendo la información que figura en la aplicación y que se corresponde con la relacionada en el artículo 13 del Reglamento, junto con el etiquetado y la fotografía del envase. También deben notificar aquellos distribuidores que comercialicen un cosmético ya comercializado en otro estado miembro y traduzcan o modifiquen su etiquetado con objeto de cumplir la legislación nacional.
Through this portal must submit the necessary documentation to the Agency for Medicines and Health Products. In such documentation as indicated above should make it clear that stores approved by the Competent Authority, acting owned or subcontracted owned.
These stores always have a specific size depending on the activity of the company and type of product. Apart it is essential to have a medical technician responsible to ensure the release of imported and distributed lots. Without authorization the company may not market imported products that you want.
The purpose of this Declaration and responsible for the electronic filing of documents is also important for poison centers, as this can quickly treat any poisonings as well as national authorities in undertaking a better control of the market.