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 16 February onwards, this application must be used for any type of variation, whether new or ongoing to submit the revised SmPC and/or PIL.
Asphalion offers the service to prepare the electronic submission of the SmPC and PIL in the required format.
For more information, please refer to this link (information only available in Spanish) or contact us [email protected]
