Recently the royal decree concerning the hospital exemption for the production of advanced therapy medicinal products is published (March 1, 2017). The Federal Agency for Medicines and Health Products organized an information session on April 24, 2017. The following information is provided by FAMHP during the information session and will also be available on the FAHMP website:

• ATMP – Hospital exemption legal framework
• Procedure to apply for a hospital exemption for ATMP
• Content of the application dossier
• Pharmacovigilance activities to be performed by the holder
• Application for GMP-certification
• Inspection of a ATMP-HE