Inden afslutningen af den gensidige anerkendelsesprocedure i alle EU - medlemsstaterne (bortset fra Sverige) indbragte Frankrig en sag for EMEA ud fra den betragtning, at graviditetsforebyggelsesprogrammet som foreslået i produktresuméet under den gensidige anerkendelsesprocedure ikke var acceptabelt og krævede ændringer af forskellige afsnit i produktresuméet.
Before the end of a mutual recognition procedure in all EU Members States (except Sweden), France presented to the EMEA a referral considering that the pregnancy prevention programme as proposed in the MRP summary of product characteristics was not acceptable and requested amendments to various sections of the SPCs.