Spain: New AEMPS application for the registration of biocidal products and personal care products

In short

The Spanish Agency for Medicines and Medical Devices (“AEMPS“) has launched a new application with the aim of facilitating the registration and improving the communication of biocidal products and personal care products, as well as concerning the facilities that manufacture, import and store biocidal products in Spanish territory.

More in detail

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 close until the end of 2022 to allow companies to verify that information has been correctly migrated.

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.
• Authorization of facilities for the manufacture, import and storage of biocidal products located in Spain.
• Modification and extension of the authorizations of the biocidal installations above.
• Electronic payment of royalties and upload of digitally signed releases.

Consequently, all requests for the above procedures with 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 a complementary user manual for the new application, which can be consulted at the address 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. In this regard, companies must submit to the AEMPS the technical documentation of the product (harmlessness and efficacy), the information provided to end users and an evaluation report on the classification, labeling and packaging of the finished product, in line with the implementation of the objectives of the EU sustainability strategy for chemicals.