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French Administrative Supreme Court annuls marketing authorisation for procedural reasons

18 February 2020

Florida Palm Biogaran is a herbal medicinal product for the treatment of moderate urinary disorders associated with benign prostatic hyperplasia. On 31 December 2019, the French Administrative Supreme Court annulled the marketing authorisation (MA) for the medicinal product on procedural grounds. As a result, the medicine should no longer be prescribed or dispensed.

The French Administrative Supreme Court's decision follows an administrative recourse by the pharmaceutical company Pierre Fabre, which markets Permixon, another Florida Palm-based medicinal product. In its application for a MA, Biogaran relied on Permixon's bibliographical data (via an abridged procedure) as Biogaran contended that its application related to a medicinal product for which the active substance had been in well-established medicinal use for at least ten years in France, the European Community or the European Economic Area, and has recognised efficacy and an acceptable level of safety. However, since the active substance used in the composition of Florida Palm Biogaran is obtained from a different extraction process than the one used by Pierre Fabre for Permixon, the French Administrative Supreme Court ruled that the two medicinal products cannot be considered similar, and therefore the abridged procedure was not applicable.

Following the annulment of the MA, the decisions related to the inscription on the reimbursement lists of Florida Palm Biogaran have been cancelled accordingly.

In response, the French National Agency for Medicines and Health Products Safety (ANSM) has stated that the court's decision is not linked to any reason relating to the safety or quality of the medicinal product.

A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, February 2020 Issue (Thomson Reuters).