Information related to the implementation of the Commission's Decision on the re-classification status of ellaOne
The European Commission has issued the Implementing decision on the change in classification status from prescription to non-prescription for the emergency contraceptive ellaOne (ulipristal acetate). This Decision came into effect on 9 January 2015 and is legally binding to all European Union Member States, including Croatia and it is issued based on the recommendation of the European Medicines Agency (EMA).
The marketing authorisation holder in the EU, Laboratoire HRA Pharma has committed itself to implement the variation within six months from the Decision issuing and the implementation of this Decision is planned gradually during 2015 in all EU Member States, except in those Member States where the dispension of contraceptives requires a medical prescription. With an aim of preparation for the non-prescription dispensation of ellaOne, number of activities will be carried out within this period in Croatia and other EU Member States where this decision is binding.
Until the fulfillment of the conditions for dispensation of ellaOne without prescription, the dispensation of this medicine will remain solely as prescription only. Also, we would like to highlight that the emergency contraception with ellaOne may be used only on occasional circumstances and may not replace the regular contraception.
More information is available under the link below.