Is an Update of the QPPV´s Contact Details a Variation?

The Co-ordination Groups for Mutual Recognition and Decentralized Procedures (CMDh and CMDv) 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)?"

Answer:

  • For medicinal products for human use changes of the contact details of the QPPV or location of the PSMF (pharmacovigilance system master file) are introduced via the Art. 57 database and do therefore not require a variation.
  • Medicinal products for veterinary use: If a Detailed Description of the Pharmacovigilance System (PVS) is authorized as part of the marketing authorization (MA), a change in the QPPV should be submitted via a Type IAIN variation provided that the PVS itself remains unchanged. In all other cases, the change in QPPV can be simply notified within an upcoming single or grouped variation provided the change is indicated in the cover letter. In this case, the applicant includes an update of the contact details of the QPPV as editorial change.

 More information can be found in the Q&A - List for the submission of variations according to Commission Regulation (EC) 1234/2008.

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