Comparative Course and Outcome of the Mutual Recognition Procedure with Two Related Progestagen-Only Contraceptive Products: Cerazette® and Implanon

In 1998, NV Organon successfully completed two Mutual Recognition Procedures (MRPs) for two progestagen-only contraceptive products: Cerazette® (tablet) and Implanon® (subdermal implant). Two different reference member states (RMS) were involved. For Cerazette® the Swedish Medicines Product Agency acted as the RMS, whereas the Dutch Medicines Evaluation Board acted as the RMS for Implanon®. This article compares the two MRPs. It discusses the progress and contents of the two procedures in terms of the approval times needed for the products in each RMS, the validation process, the start of the actual procedure, the number and types of questions raised by the concerned member states, and the results of the break-out session. Furthermore, the effect of each MRP on the outcome of the contents of the Summary of Product Characteristics (SmPC) and the time required for issuing the national marketing authorizations will be discussed. Based on the experience of NV Organon, it is concluded that the MRP is a mature European registration procedure, providing that good cooperation between the RMS and the pharmaceutical company is established.