In the past, a Spanish Digital Certificate was required to access the Spanish portal RAEFAR and management texts tool. Therefore, in cases where the MAH did not have a local contact in Spain, AEMPS was more flexible on the requirements of national activities handled through these portals.
From beginning 2017 a Spanish Digital Certificate to access RAEFAR is not needed anymore, but credentials are still mandatory and have to be requested to AEMPS. That means anyone can access the portal despite not being located in Spain and without a Digital Certificate.
If you are interested in this and other related national topics, join our webinar, Speed up Spain – An approach to Regulatory procedures in Spain, which will take place on 19th June at 15:00h CEST. The topics covered in the webinar include Spanish authorities’ portals and databases, and mandatory National Requirements that have to be performed before launch-to-market and during maintenance period.
The webinar will be run by Asphalion experts with large experience in National Procedures, Carmen Ulla, Regulatory Affairs Director, and Michael Schaub, Director Munich Office.
Do not miss the opportunity and register for the webinar without charge here: https://asphalion.com/webinar/eaf/