Global Drugs & Biologics Update
February 24, 2015
Europe |
| European Medicines Agency (EMA) |
| Guidance |
Post-marketing data submission requirements clarified |
EMA has issued guidance that clarifies the data submission obligations of marketing authorization holders concerning newly authorized medicines and variations to existing marketing authorizations. The data required by the pharmacovigilance amendments of 2010 must be submitted using the eXtended EudraVigilance Product Report Message (XEVPRM) format into a central database maintained by EMA. |
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