Download the 10 key requirements to launch your medicinal product in the EU: Local Representatives National Codes Blue Box Serialization Local Databases Local launch Date Notification Promotional Materials Educational Materials Local Wholesale Distribution Authorization (WDA) Shared Pack and Stock…
Our experts at BlueReg are covering the different pathways to accelerate your medicinal product launch in Europe. The different subjects covered are : 1. Regulatory Strategy - How to prepare the regultory launch sequence for your first medicinal product in…
Variations are any change to the currently approved content of a Marketing Authorisation (MA) dossier and are essential in the lifecycle management of a medicinal product. For human use, this mainly concerns articles 8(3), 9, 10, 10a, 10b, 10c of…