Requirements for the qualified person for pharmacovigilance and reporting of appointment/change of the QPPV to SÚKL

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3. Requirements for the qualified person for pharmacovigilance and reporting of appointment/change of the QPPV to SÚKL
In force from:
31.01.2025

Pursuant to Sec. 91a(2) of the Act on Pharmaceuticals, the marketing authorization holder shall provide the name, surname and contact details of the qualified person for pharmacovigilance to SÚKL.

This obligation applies to all marketing authorization holders, regardless of the location of the PSMF.

QPPV shallreside and operate in the EU, Norway, Iceland or Liechtenstein. GVP Module I – Pharmacovigilance systems and their quality systems, defines the requirements to be fulfilled by QPPV. In order to carry out their activities, QPPVs must have

  • Both theoretical and practical knowledge for the performance of pharmacovigilance activities,
  • Expertise and access to expertise in the fields of medicine, pharmaceutical sciences, epidemiology, and biostatistics,
  • where the QPPV does not have medical education, the marketing authorisation holder shall ensure that the QPPV is assisted by a medically trained person and this assistance shall be duly documented.

How to report QPPV appointment/change to SÚKL

Marketing authorization holders shall inform the Pharmacovigilance Department of SÚKL via e-mail to farmakovigilance@sukl.gov.cz. The subject of the e-mail shall include information on the type of change (QPPV change or appointment) and the name of the marketing authorization holder. For shared pharmacovigilance systems, only the first marketing authorization holder indicated on the front page of the PSMF shall be included in the subject of the e-mail, the other marketing authorization holders shall be listed in the body of the e-mail.

The contact information in the body of the e-mail must include name, e-mail address, telephone number, and postal address of the QPPV.

Deadline for reporting QPPV appointment/change to SÚKL

Marketing authorization holders shall notify the Pharmacovigilance Department of SÚKL within 7 calendar days following the appointment/change of the QPPV or change of their contact details.