Qualified Person for Pharmacovigilance
Under the European and national legislation, every marketing authorisation holder must appoint a qualified person to oversee its pharmacovigilance activities (Qualified Person for Pharmacovigilance or QPPV).
This person is known as the European Qualified Person for Pharmacovigilance (EU-QPPV) and must be resident in Europe. Following European Economic Area (EEA) agreements, the QPPV may also reside and operate in Norway, Iceland or Liechtenstein. Appointing a national contact person for pharmacovigilance is also required if the QPPV resides outside the Netherlands or if the QPPV does not master the Dutch language in speech and writing.
You can register the national contact person for Pharmacovigilance by providing the details to the Medicens Evaluation Board (MEB). It is no longer necessary to also register the national contact person with the inspectorate.
As the requirements for the national contact person for pharmacovigilance are not specified in the Dutch legislation, the Health and Youth Care Inspectorate and the MEB provide the following guidance:
The national contact person for pharmacovigilance must:
- Report to the QPPV (reporting in this context relates to pharmacovigilance tasks and responsibilities and not necessarily to line management).
- Master the Dutch language in speech and writing (this local contact person should not only act as contact person for the national competent authorities, but may also have contact with patients and health care professionals).
- Be knowledgeable with the relevant Dutch legislation, guidelines and procedures.
- Be medically qualified (basic medical training at academic level), or have access to a medically qualified person.
- Have a good back up procedure in place in case of absence.