Information related to the implementation of the Commission's Decision on the re-classification status of ellaOne
20.01.2015
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) that HALMED made publicly available on 21 November 2014. 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.
Before starting the dispensation of ellaOne without prescription in Croatian pharmacies, as a necessary prerequisite, medicinal product will be produced with newly approved labelling and package leaflet adapted to the non-prescription status. Also, before changing the prescription status of ellaOne, as an additional measure, the marketing authorisation holder has decided to prepare informational educational materials and to carry out an extensive educational programme in cooperation with professional organisations in order to improve the knowledge of healthcare professionals on emergency contraception with an aim of providing scientific information to the medicine users. The marketing authorisation holder in the EU, Laboratoire HRA Pharma, will carry out these activities in collaboration with the local representative in Croatia, Arenda d.o.o. HALMED will inform healthcare professionals and the general public about the beginning of ellaOne dispensation without prescription.
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.
HALMED will promptly make available on its webpages all relevant information related to the implementation of the Commission's Decision on the change in classification status from prescription to non-prescription for the medicinal product ellaOne.
