To overview: Risk assessment and researchĭif­fer­en­ti­a­tion and clas­si­fi­ca­tionĬlin­i­cal In­ves­ti­ga­tions and Per­for­mance Eval­u­a­tions Re­quest for waiv­ing the au­tho­ri­sa­tion To overview: Reports and Corrective ActionsĪp­pli­ca­tion for a de­ci­sion on the re­quire­ment to ap­prove a clin­i­cal in­ves­ti­ga­tion of a med­i­cal de­vice Plac­ing med­i­cal de­vices on the mar­ket To overview: Medicinal products information Phar­ma­covig­i­lance Risk As­sess­ment Com­mit­tee (PRAC) To overview: Periodic Safety Update Reports (PSURs)

Pe­ri­od­ic Safe­ty Up­date Re­ports (PSURs) Risk in­for­ma­tion on medic­i­nal prod­ucts List of medicines un­der ad­di­tion­al mon­i­tor­ingĮu­ro­pean Database on Ad­verse Drug Re­ac­tion Re­ports Rote-Hand-Briefe and In­for­ma­tion Let­ters To overview: Issues Relevant for LicensingĮU-reg­u­la­tion on medic­i­nal prod­ucts for chil­dren Pub­li­ca­tion of clin­i­cal tri­als re­sults acc. Par­al­lel im­port of medic­i­nal prod­ucts To overview: Types of Marketing AuthorisationĬom­ple­men­tary and Al­ter­na­tive Medicines (CAM) and Tra­di­tion­al Medic­i­nal Prod­ucts (TMP)ĭe­cen­tralised Pro­ce­dure (DCP) - Mu­tu­al Recog­ni­tion Pro­ce­dure (MRP)

Vol­un­tary Har­mon­i­sa­tion Pro­ce­dure ( VHP)