Pharmacovigilance and orangeglobal

In recent years, pharmacovigilance (PV) has acquired increasing importance in patient safety. This is reflected not least in a series of new or revised laws, regulations and directives at national and EU level governing various aspects of pharmacovigilance. The German Medicinal Products Act (AMG) and various regulations that are based on the AMG (particularly the AMWHV), regulate the requirements for PV. As a result of the 16th AMG amendment for the implementation of the EU specifications, the PV regulations will be greatly expanded. At the level of the European sources of law, Directive 2001/83/EC and Directive (EC) No. 726/2004 form the superordinate legal basis for PV regulation.

As a result of the EU Pharma Package 2010, the above-named EU directive and regulation were expanded. The Commission Implementing Regulation (EU) No. 520/2012 has also substantiated the requirements for the practice of PV. Furthermore, Regulation (EU) No. 658/2007 about financial sanctions in case of violations against certain obligations related to central marketing authorisations comes into play, also from the perspective of PV. Many Good Vigilance Practice (GVP) modules have also been finalised in recent years or are in the process of finalisation. These are sets of guidelines that further substantiate the expectations for implementing pharmacovigilance in practice in compliance with directives as part of the conduct of pharmacovigilance in the EU. GVP applies to marketing authorisation holders, the European Medicines Agency (EMA) and the regulatory authorities of Member States.

All of these laws, rules, regulations and directives specifically address the complexity of the issues surrounding pharmacovigilance. Due to the increasing volume of work, many companies are starting to realise that they have a need for outsourcing and are looking for suitable solutions. In orangeglobal you have a strong, experienced partner at your side, whom you can trust to handle the sometimes very time-critical processes efficiently.