Detailed Description of Pharmacovigilance System

The Detailed Description of Pharmacovigilance System (DDPS) is an important part of monitoring veterinary medicinal products.  Pharmacovigilance is the monitoring of adverse events and suspected adverse events.

Een DDPS vormt een verplicht onderdeel van het wetenschappelijk dossier dat u als handelsvergunninghouder indient om een markttoelating van een diergeneesmiddel te kunnen verkrijgen. De eis voor het opstellen van een DDPS als onderdeel van het wetenschappelijk dossier staat in Artikel 12(3) van Richtlijn 2001/82/EC.

A DDPS is an obligatory part of the scientific dossier that you as a marketing authorisation holder submit in order to obtain marketing authorisation for a veterinary medicinal product.  The requirement for the compilation of a DDPS as part of the scientific dossier can be found in Article 12(3) of Guideline 2001/82/EC.

In a DDPS you give a detailed description of your pharmacovigilance system and demonstrate that you are competent to collect and evaluate reports of adverse events in the correct manner.

You also indicate that you have a QPPV (Qualified Person PharmacoVigilance). This is a person within your company who is responsible for the correct processing of all pharmacovigilance data.

All requirements which a DDPS must fulfil can be found in the documents below:

Submitting a DDPS

The DDPS is an integral part of the process of submitting an application for marketing authorisation of a veterinary medicinal product.  If your DDPS has already been approved, it does not have to be assessed again.  In this case a DDPS declaration form should be submitted. However, the DDPS should still be included under annex 5.20 of the application form.

Changes in a DDPS

When changes occur in a DDPS, you as the marketing authorisation holder should submit a request for changes.