PHARMACOVIGILANCE SYSTEM MASTER FILE (PSMF) The Pharmacovigilance System Master File (PSMF) is a detailed description of all aspects related to how a pharmaceutical company is… Read more »
Read MoreIt is difficult to get clear information about the requirements for local contact persons for pharmacovigilance in the EU as these are determined by the… Read more »
Read MoreIf a change of qualified person for pharmacovigilance/responsible person for EudraVigilance (QPPV/RP), named person or legal representative within the organisation occurs, you need to notify… Read more »
Read MoreEU PSMF number For the EU the PSMF number is a unique code (MFL EVCODE) that is assigned by the eXtended EudraVigilance Medicinal Product Dictionary… Read more »
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A sponsor who is planning to submit a marketing application (or supplement to an application) for a new active ingredient, new indication, new dosage form,… Read more »
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