Specific Request EAHC/2011/Health/14 for the Implementation of Framework Contract EAHC/2010/Health/01 Lot 1
21 December 2012
This study investigates the availability of medicinal products for human use in the EU and EEA, focussing on the authorisation procedures for medicinal products, a principal area of EU competence1
For the purposes of this study, availability of medicinal products is understood to mean the availability to patients of medicinal products in a pharmacy setting. Following the Terms of Reference and due to the fact that the majority of existing information refers to availability of individual products, the study uses medicinal products for human use as the unit of analysis. However, in most cases it is the limited availability of active substances rather than limited availability of individual products that constitutes a public health risk. Therefore, where possible, the study also aims to explore the public health implications associated with non-availability of active substances.
In addition to collecting and analysing the data on availability, the study also investigates the problem drivers and examines the effectiveness of existing European legislative provisions in addressing these problems, making recommendations where relevant.