Change in status to facilitate access for women across Europe

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended a change in classification status from prescription to non-prescription for the emergency contraceptive ellaOne^® (ulipristal acetate). This means that the medicine could be obtained without a prescription in the European Union (EU).

This recommendation is the first-ever of its type regarding an oral contraceptive product, which should apply in all EU member states in 2015, after a final endorsement by the European Commission.

ellaOne^® first became available in Europe with a medical prescription at the end of 2009. This was then followed by its launch in the United States in 2010 after approval by the Food and Drug Administration (FDA). These approvals were based on full clinical tests and research. ellaOne^®  has already been used by more than 3 million women in 70 countries over the past 5 years.

Based on the assessment of available data, the CHMP found that ellaOne^® can be used safely and effectively without medical prescription.

Professor Anna Glasier, from the University of Edinburgh (Scotland), agreed that the newly announced enhanced access for women is a key milestone and said, “ellaOne^® is a highly effective emergency contraceptive which we’ve been using for 5 years now, and making it more accessible and available more quickly from pharmacies is a logical and sensible thing to do. Women need to get access to emergency contraception as soon as possible in order to be in the best position to avoid an unintended pregnancy; this is a matter of public health”.

This CHMP recommendation will now be sent to the European Commission for a legally binding decision within 2 months.
HRA Pharma expects ellaOne^® to be available directly from pharmacies in 2015 across the European Union.