VI.C.5. Collaboration with the World Health Organization and the European Monitoring Centre for Drugs and Drug Addiction

In accordance with Article 28c(1) of Regulation (EC) No 726/2004, the Agency shall make available to the WHO (in practice the Uppsala Monitoring Centre (UMC) as the WHO Collaborating Centre for International Drug Monitoring) all suspected adverse reaction reports occurring in the EU. In this regard, ICSRs from the EU submitted to the EudraVigilance database by competent authorities in Member States and marketing authorisation holders are transmitted to the WHO electronically in ICHE2B(R3) format in line with the latest version of the EudraVigilance Access Policy for Medicines for Human Use35 . Details are set out in a service level agreement between the Agency and the WHO, accessible on EMA website36 . This replaces the requirements of EU Member States participating in the WHO Programme for International Drug Monitoring to directly report to WHO suspected adverse reactions reports occurring in their territory. A business process map and a process description for the submission of ICSRs, from the EudraVigilance database to the WHO Collaborating Centre for International Drug Monitoring, are presented in VI. App 4.

The Agency and the European Monitoring Centre for Drugs and Drug Addiction shall also exchange information that they receive on the abuse of medicinal products including information related to illicit drugs [REG Art 28c(2)].