EMA and the European Commission have agreed some transitional arrangements in order to streamline the implementation of this new process. Additional EMA IT systems were also affected during that period. It identified the stakeholders affected, their needs and interests. Each Member State had the possibility to align its own communication ich guidelines for stability testing pdf with the one prepared by EMA.
The document is regularly updated and should be consulted as a first reference before contacting the Agency’s service desk. They also include detailed documentation on the changes in reporting, downloading and analysis of data. ICSR download functionality to enable marketing authorisation holders to download ICSRs concerning their products or ICSRs reported with a substance for which they hold a marketing authorisation in the EEA.
EMA granted marketing authorisation holders access to EVDAS to use signal detection, analytical and reporting functions to the extent necessary to fulfil their obligation. How can I be informed about the change? They are also listed below.