How to register a QPPV?

Marketing Authorization Holders (MAHs) are legally required to have a Qualified Person for Pharmacovigilance (QPPV) based in the European Union (EU) in place at all times. The QPPV must be registered in Eudravigilance. MAHs are also required to provide the name, phone number and email address of a regulatory contact point. This can be a staff member or a department. In addition, commercial and non-commercial sponsors and national competent authorities should nominate a responsible person (RP) for EudraVigilance and register them in Eudravigilance.

Change of the EU QPPV/RP

If the QPPV or RP changes within an organization, the organization must nominate a new QPPV or RP within 10 calendar days. The existing QPPV/RP cannot be removed from EudraVigilance until their replacement is registered, and registration documents for the newly appointed QPPV/RP need to be included. Thus, on the EMA website EudraVigilance: how to register, the EudraVigilance registration documentation has been updated. Among other things, it is now pointed out that the EMA reserves the right to contact the previous QPPV/RP if necessary in order to validate the variation applied for. In addition to the new QPPV/RP, the previous QPPV/RP should also sign the cover letter or reasons should be given as to why this is not possible. The document New Organization First User EU QPPV/RP or Change of EU QPPV/RP has also been updated. It describes measures that are required for the registration or change of the QPPV/RP. It also refers to the signature of the previous QPPV/RP for the cover letter and that the EMA must be informed within 10 days in the event of a change.