In short

The Spanish Agency for Medicines and Medical Devices (“AEMPS

This new application has been fully operational since April 29, 2022, replacing the obsolete COSMET, active since 2004. All product and installation data collected in the old application has been migrated to the new one. However, Cosmet will not shut down until the end of 2022 to allow companies to verify that information has been migrated correctly.

The new computer system allows interested parties to carry out the following procedures:

  • Authorization of biocides and personal care products.
  • Modification and extension of the authorization of biocides and personal care products.
  • Modification and extension of the authorizations of the biocidal installations above.
  • Electronic payment of fees and download of the authorizations signed numerically.

Therefore, all requests for the above procedures to the AEMPS must now be made via this new platform, accessible by clicking on this link.

To access the application, national companies must identify themselves via the CLAVE platform, while foreign companies must select their country of origin and identify themselves by e-mail and password. The new application home screen will display the list of active applications at all times, for both products and installations, sorted by seniority. The AEMPS has published an additional user manual for the new application, available on this link.

The AEMPS has also published new instructions for the application for authorization of personal care products, which can be consulted by clicking on this link. The application takes into account the existence of a wide variety of personal care products, with specific information being requested for each type of product. In Spain, the marketing of personal care products requires prior authorization from the AEMPS. A cet égard, les entreprises doivent soumettre à l’AEMPS la documentation technique du produit (innocuité et efficacité), les informations fournies aux utilisateurs finaux et un rapport d’évaluation sur la classification, l’étiquetage et l’emballage du produit fini, conformément à la mise en œuvre de les objectifs de la stratégie de durabilité de l’UE pour les produits chimiques.