Objectives of the conference
2015 marks the 50th anniversary of the European Union Pharmaceutical Legislation. Without any doubt, this legislation has considerably improved the safety, quality and efficacy of all kinds of medicines in the European Union and beyond. However, questions have been raised as to whether the whole legislative and regulatory system for pharmaceuticals has not become too complex, hence hindering access to important medicines - either as a prescription or as a non-prescription medicine. More proportionality has therefore become an important issue in the debate on the future regulation of medicines. This concerns the marketing authorisation system in general including the procedures for variations but in more specific terms also the implications of the legislative provisions on pharmacovigilance and falsified medicines.
Immediate changes in the pharmaceutical legislation are unlikely to happen. The conference will therefore focus on adjustements in the implementation of existing rules and consequently on improvements which can be made in a shorter time frame.