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 is not fluent in the Dutch language, you should appoint a national contact person.
The national contact person for pharmacovigilance:
- acts as contact person with the authorities
- acts as contact person for patients and medical healthcare practitioners
- should be appointed at the moment that a marketing authorisation holder will market a product in the Netherlands.
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.
Registration
Please notify the MEB of your national contact person for pharmacovigilance by means of the registration form.