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  5. Pharmacovigilance


Pharmacovigilance is the science and activities relating to the identification, assessment, understanding, and prevention of adverse effects and health problems which are related to the use of medicinal products. It strives to find an appropriate balance between the therapeutic effects of those medicinal products in treating the condition for which they are intended, and any adverse health effects. International legislation demands that these activities are conducted by marketing authorization holders (MAHs), practitioners and authorities in a structured and coordinated manner.

In the Netherlands, the Medicines Evaluation Board (MEB) has been designated as the national competent authority for the coordination of pharmacovigilance. They are responsible for the safety monitoring of medicinal products in the Netherlands and make the final decision about the authorisation of these products.

Every marketing authorization holder (MAH) for a medicinal product is responsible for the quality and safety of its products. The Dutch Health Care Inspectorate is the supervisory authority which monitors the pharmacovigilance activities of these MAHs in the Netherlands. Every marketing authorization holder is subject to regular inspections.

Qualified Person for Pharmacovigilance (QPPV)

Under the European and national legislation, every marketing authorisation holder must appoint a qualified person to oversee its pharmacovigilance activities. 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 MEB and to IGZ.

As the requirements for the national contact person for pharmacovigilance are not specified in the Dutch legislation, the Health Care Inspectorate (IGZ) 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.

Pharmacovigilance System Master File (PSMF)

As of July 2015, every MAH is required to have a Pharmacovigilance System Master File (PSMF) which is a paper or electronic document describing the pharmacovigilance system of the MAH. The information contained in the PSMF should be an accurate and up-to-date reflection of the pharmacovigilance system under the QPPV’s responsibility. It should be located either at the site in the EU where the main pharmacovigilance activities of the marketing authorisation holder are performed or at the site in the EU where the QPPV operates.
MAHs are required to submit information concerning all medicinal products for which they hold a marketing authorisation in the EU, to the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD). This also applies to the pharmacovigilance details such as the name and contact details of the (EU)QPPV and the location of the PSMF.

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