Pharmacovigilance
The Inspectorate oversees the pharmacovigilance activities of pharmaceutical companies (more specifically, the holders of the drug registration and marketing authorisation for the Netherlands).
Pharmacovigilance is the science and associated activities which deal with the identification, assessment, understanding and prevention of undesirable side effects and health problems which are related to the use of prescription drugs. It strives to find an appropriate balance between the therapeutic effects of those drugs in treating the condition for which they are intended, and any adverse health effects ('side effects'). International legislation demands that these activities are conducted by pharmaceutical companies, practitioners and authorities in a structured and coordinated manner.
Under the Dutch Geneesmiddelenwet (Medicines Act), every market 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. Every EU-QPPV is subject to regular inspections.
Detailed Description Pharmacovigilance System (DDPS)
If you are the registration holder for one or more pharmaceutical drugs, you can download the reply form for the DDPS analysis here (in Dutch only). Please return the form and the generic part of your DDPS to Farmacovigilantie@igz.nl.
Legislation
Medicines Act
European Directive 2001/83/EG
Regulation (EC) 726/2004
Regulation (EC) 540/95
Volume 9A
Meer informatie