Authorization For Metrodin in Germany and Ireland Questioned

Despite the European Union Committee for Proprietary Medicinal Products' favorable opinion on Ares Serono's Metrodin HP (urofillitropin; hFSH) in February 1993, Germany and Ireland have so far not granted authorization to this pharmaceutical product, European Commissioner Martin Bangemann has said in a recent answer to a written question by Member of the European Parliament Freddy Blak.

Further to the CPMP opinion, "the Commission has closely followed the progress of all members states and has repeatedly invited member states to update their positions," he said, adding that "the most recent request in this case was in July 1994," but this fertility treatment, described by Dr Bangemann as "an important new medicinal product," is still not available throughout the EY, he said.

The situation will shortly change, he stressed. While the CPMP at present only delivers a scientific opinion and the authorization decision remains in the competence of each member state, from the beginning of 1995 authorization decisions on this type of product will be made centrally, with the setting up of the European Medicines Evaluation Agency, he said.