This overview shows the periods of validity and areas of application for different versions of ICD-10- GM in addition, it may also contain a reference to the publication in the Federal Gazette of the date that the version became effective. New information in the topic licensing New information in the topic medical devices New information in the topic medicinal products New information in the topic clinical trials New information in the topic Pharmacovigilance
OUTLOOK VERSION HISTORY CODE
New information in the topic code systems Study Submission and User Registration To overview: DRKS - German Clinical Trials Register Scientific Advice and Pre-submission MeetingĬHMP Committee for Medicinal Products for Human UseĬOMP Committee for Orphan Medicinal ProductsĭRKS - German Clinical Trials Register Kick-off Meeting through the Innovation Office at the BfArM Pilot of a nationwide electronic death certificate National project rare diseases coding Request German translations of SNOMED CT concepts Notification of Medical Devices and In vitro Diagnosticsĭatabase Information Medical Devices Notificationĭatabase Information In Vitro Diagnostic Medical Devices Notificationsĭatabase Information Medical Devices AddressesĪpplication for a SNOMED CT affiliate licence 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 Registered Online Medicine Retailers To overview: Medicinal products information Pharmacovigilance Risk Assessment Committee (PRAC)
![outlook version history outlook version history](https://i.ytimg.com/vi/owPHUGX_5aA/maxresdefault.jpg)
OUTLOOK VERSION HISTORY UPDATE
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)