by In2Pharma | Aug 23, 2024 | News
Luxembourg La Division de la Pharmacie et des Médicaments de la Direction de la Santé (DPM) has published updated instructions for the distribution of DHPC (version 3.0 – 06/2024) and aRMM (version 4.0 – 06/2024) in Luxembourg. A change in the updated version is...
by In2Pharma | Sep 3, 2021 | News
Europe On 26 July 2021, EMA has launched the IRIS platform, a secure online platform to report marketing status changes and withdrawn product notifications of centrally authorised medicinal products (CAPs) to EMA.The marketing status overview will provide to EMA and...
by In2Pharma | Sep 3, 2021 | News
Europe EMA published a guideline, effective from 1 January 2022, on quality documentation for medicinal products when used with a medical device (first version). The guideline describes the information that should be presented in the Quality part of a MA dossier for a...