EU warns Ireland over PI applications

The European Commission has threatened to take the Republic of Irelandto the European Court of Justice over what it considers to be the unacceptably long times taken by the Irish authorities to approve parallel import applications for medicines.

The length of the procedures for these products, which average approximately two and a half years, constitute an illegal trade barrier, and the majority of them could be replaced by use of a simplified procedure, according to a reasoned opinion from the Commission. It has given the Irish government two months in which to produce a solution to the problem.

Meantime, the review which Ireland has requested by the Organization for Economic Cooperation and Development of its national regulatory practices and domestic regulatory reforms has now been completed and is due to be published on April 24.