Licencing

Radiopharmaceuticals as pharmaceuticals have to be registered. The documentation (Module 2-5) for Marketing Authorisation Applications (MAA) in Europe and USA is identical. The Module 1 contains the specific regional information.

Common Technical Document (CTD) provides guidance for the compilation of dossiers for applications for marketing authorisation in Europe, USA and Japan and is applicable in Europe for centralized procedure, mutual recognition procedure (MRP), decentralised procedure (DCP) and the national procedure, respectively.

All Medi-Radiopharma products are registered in Hungary and MR-Procedures are used to get product licences in other European Member States.

Outside Europe we follow National Licensing Rules in each country.