The European Commission, in a historic ruling, has confirmed the authorisation of the emergency contraceptive, ellaOne® (ulipristal acetate, 30mg), to be accessible direct from pharmacies without the need for a prescription from a doctor. This is the first ever decision of its type regarding any oral contraceptive product applicable to all EU member states, according to national implementation procedures. This new ruling will empower over 120 million women across the whole EU to gain direct access to emergency contraception (press release available on www.hra-pharma.com).
This legally-binding decision follows an earlier positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP), which concluded that ellaOne® works best if used during the first 24 hours, and can be used safely without a medical prescription. Today’s decision is a further testament to the acceptance of the need for women to be offered improved access to emergency contraceptive options.
ellaOne® will first be available in pharmacy without a prescription in some European countries from next month (February 2015) with a full launch program taking place across the EU during the rest of the year.