Bartłomiej Ochyra, Adam Przybyłkowski

Signal management: new responsibilities and tools for marketing authorisation holders – how to prepare for the legal obligation the continuous monitoring of the EudraVigilance database 
2018-05-10

On 22 February 2018 a pilot period of one year monitoring of EudraVigilance database (EV) by marketing authorisation holders (MAHs) was started. During this process MAH is obligated to continuously monitor the data available in EV with a frequency proportionate to the identified risk, the potential risks and the need for additional information. It should be highlighted that a pilot concerns only these MAHs whose products contain the active substances or their combinations included in the list of active substances involved in the pilot. Please note that the EV database is not the only data source used to signal detection. Continuous monitoring of the EV database should be carried out in parallel with the analysis of other data sources, including the MAH database. This task is a big challenge, especially for small pharmaceutical companies.

Keywords: signal detection, EudraVigilance database, continuous monitoring, marketing authorization holder responsibilities

© Farm Pol, 2018, 74(5): 309–315