As a marketing authorisation holder you are required to appoint an EU Qualified Person responsible for Pharmacovigilance (QPPV). Additionally, if the QPPV is resident outside the Netherlands or does not speak and write Dutch, you are required to appoint a national contact person.
The national contact person for pharmacovigilance acts as an intermediary with the authorities, and also as the point of contact for patients and medical healthcare practitioners.
Guidelines for a national contact person
The MEB and the Health and Youth Care Inspectorate (IGJ) have compiled guidelines for a national contact person. This person:
- Should have a thorough command of both spoken and written Dutch.
- Should have knowledge of the relevant national legislation, guidelines and procedures.
- Should have a medical qualification (university medical school graduate), or have access to someone with medical training. These arrangements must be clearly recorded.
- Should maintain contact with the QPPV concerning the range of duties related to pharmacovigilance.
- Should have a back-up procedure in place in the event of absence.
Please notify the MEB of your national contact person for pharmacovigilance by means of the registration form.