The Pharmaceutical Journal
Vol 268 No 7187 p274-79
2 March 2002

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Formulation changes will not stop parallel importing in Europe

Parallel imports do not have to be withdrawn from the market if manufacturers replace the original product with a slightly different formulation, the European Court is expected to rule.

Giving an opinion on a German case involving Ferring's Minirin (desmopressin) spray, the advocate-general, whose opinion is usually accepted by the court, says that parallel trade of Minirin cannot be halted in Germany because Ferring withdrew its own authorisation in order to relaunch an essentially identical product containing a different preservative.

The chief executive of the German PI trader involved (Eurim-Pharm) said: "This opinion clearly states that a marketing authorisation for a parallel-traded product, once granted, possesses its own legal status, independent of that of the original marketing authorisation. Provided the European Court comes to the same conclusion, which we expect, it would bring to an end manufacturers' tactics of playing around with several approvals for essentially identical products, designed only to remove existing parallel-traded products, at least temporarily, from the market. If the opinion is upheld, Eurim-Pharm is also in a position to claim damages from Ferring."