The CMDh recently published a revised version of the Q&A paper regarding variations. With the revision of the document a new question 1.9 has been introduced: “How do I notify an update of the contact details of the qualified person for pharmacovigilance (QPPV)?”

The answer is that changes of the contact details of the QPPV or location of the PSMF are introduced via the Art. 57 database and do not require variations anymore.


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