In this White Paper, we will be sharing all the Q & A’s from our previous Webinar on ‘How to accelerate your medicinal product launch in Europe’. We have divided the Q & A’s into 4 main topics...
The promotion of medicinal products is governed by different regulations and codes in the European Union (EU). In particular, the Directive 2001/83/EC ‘of the European parliament and of the Council of 6 November 2001 on the Community code relating…
BlueReg supported a US‑based client with its promotional launch campaign in Europe for their new medicinal product.BlueReg provided full coverage for all aspects of setting up and coordinating the global and local reviews of the various promotional items of the…
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…