PARALLEL IMPORTS OF PHARMACEUTICALS Regulation and rebranding
The parallel import of pharmaceuticals is a topic that entails various issues. Among these issues, there is the problem of pharmaceuticals re-packaging that may involve rebranding.
Parallel trade in the EU was evaluated to amount to € 5,202 million (value at ex-factory prices) in 2016. Figure 1 reports an estimated share of parallel imports in pharmacy market sales for 2016 (1).
Drugs, like other goods and products, are subject to the principle of free movement of goods in the internal market, which applies to the EEA - European Economic Area (including EU member States, Iceland, Liechtenstein and Norway).
According to this principle, it is possible to practice the parallel import of pharmaceuticals, i.e. to purchase drugs, by authorized wholesalers, in an EEA Member in which these drugs are sold at a lower price, and to sell them in another Member State.
Parallel distributors must ensure that pharmaceuticals are released for free circulation in the EEA (2) and, must have a Parallel Import Authorization (AIP), granted in Italy by Agenzia Italiana del Farmaco, AIFA.
The AIP is granted with a simplified procedure with respect to that of ma ...