Mandatory use of webportal for SmPC and PIL in Spain

The Spanish Agency (AEMPS) launched in March 2013 a web application that offers MAH the option to enter the SmPC and PIL in electronic format in fragmented form. From February of this year this application must be used for any type of variation (for electronic entry of the Summary of Product Characteristics and Patient Information Leaflet).

Posted on the AEMPS website on 12 February 2015

Revipharm can help you with the electronic submission of the SmPC and PIL to the AEMPS in the required format. For more information contact us: info@revipharm.es