by In2Pharma | Mar 20, 2023 | News
Luxembourg On 20 January 2023, the Luxembourg authorities updated their document ‘Procedure for marketing authorisation applications in Luxembourg’, version 3.A new tab was created in the excel file with information regarding the Product information. The DPM of...
by In2Pharma | Mar 15, 2019 | News
Europe EMA launched a five-month pilot study to increase the correct submissions of initial marketing authorisations applications (MAAs). The pilot is a result of the 2016 EMA survey that showed validation issues occur in 90% of all initial applications. The pilot...
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...
