by In2Pharma | Feb 5, 2018 | News
EU As from 1 January 2018, it is obliged to submit the common technical document (CTD) electronically for variations of human medicines, registered via the Mutual Recognition Procedure (MRP) or Decentralised procedure (DCP). This eCTD format is mandatory for the...
by In2Pharma | Sep 6, 2017 | News
EU As from the third quarter of 2018, also purely national marketing authorization applications have to be submitted in eCTD format. For follow-up procedures (e.g. variations, renewal applications) of these national procedures, the switch to electronic format will be...
by In2Pharma | Jun 21, 2017 | News
MEB As from June 1st 2017, submission of regulatory information by applicants for marketing authorizations regarding human medicines must be submitted electronically (eSubmissions) to the Medicines Evaluation Board (MEB). All submissions have to be technically valid...
