National contact person for pharmacovigilance

Changes in QPPV (including contact details) should be notified through the article 57 database of the European Medicines Agency (EMA). There is no need to inform the MEB separately of this.

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 has to be registered at the MEB, please use the registration form below. 

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. In other words: as long as the product is not marketed in the Netherlands or if it is only available via a compassionate use programme, there is no need to appoint a national contact person for pharmacovigilance. 

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. This does not necessarily have to be a deputy, as long as the back-up procedure is clear. Optionally, a second contact person can be registered via the registration form. 

Registration

Please notify the MEB of your national contact person for pharmacovigilance by means of the registration form.

Please use this registration form also for:

• The appointment of a new contact person or simply a change of the contact details.
• The appointment of a second contact person (optional). You can indicate if the person operates as a deputy, in case of absence of the first contact person, or is responsible for  part of the product portfolio.