Change in status to facilitate access for women in the European Union

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).

ellaOne is an emergency contraceptive used to prevent unintended pregnancy if taken within 120 hours (five days) of unprotected intercourse or if a contraceptive method has failed. It works by preventing or delaying ovulation. ellaOne works best if taken within 24 hours. Removing the need to obtain a prescription for this medicine should speed up women’s access to the medicine and therefore increase its effectiveness.

Based on the assessment of available information, the CHMP found that ellaOne can be used safely and effectively without medical prescription. ellaOne has been authorised in the EU since 2009 and extensive information on its risks and benefits has been collected and studied. Its safety profile is comparable to levonorgestrel-containing emergency contraceptives, which are the most frequently used emergency contraceptives in the EU. Levonorgestrel-containing emergency contraceptives are already available without prescription in most EU countries and are registered for use up to 72 hours after unprotected intercourse or contraceptive failure.

This CHMP recommendation will now be sent to the European Commission for a legally binding decision.


Posted on the EMA website on 21 November 2014