The Court of Milan has recently ruled twice on the issue of re-packaging of medical devices imported into Italy from another EU country (decisions of 21 September 2009 and of 23 October 2009, Roche Diagnostic s.p.a. c. BB Farma Ltd.). Particularly, the Court made relied on the so called principle of trade mark exhaustion within the European Union as well as on the relevant community case law stressing that re-packaging can be permitted only to the extent that it is necessary in order to allow the product to enter into the market of a Member State by virtue of national laws and rules. On the other hand, the right holder can prevent importation should the re-packaging be exclusively aimed at gaining commercial profits. In the light of said considerations, the Court of Milan hold BBFarma did not provide enough evidence on the necessity of re-packaging, also considering that the marketing within Italian territory would have been possible by simply stick a new label on the original packaging. Moreover the burden of proof relevant to the necessity of re-packaging lies on the parallel importer.