Notification of Adverse Drug Effects

Regulated by the 6th BfArM announcement on the notification of side effects and the misuse of medicines, every marketing authorisation holder is obliged to carry out regular searches, scientific evaluation and electronic notification of adverse effects of medicines to the competent authorities. The case reports must also be recorded as “Line Listings” in the PSUR. PhytoLab takes over for you all the activities that are required in this context on your behalf, including the electronic transmission of suspected cases in XML format – including to the EMA.