EllaOne (ulipristal acetate), an emergency contraceptive, is to be made available without a prescription from community pharmacies throughout the European Union.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended a change in the classification of the drug from prescription to non-prescription status. The move follows a request for the change from the licence holder Laboratoire HRA Pharma.
After reviewing all the available data, the CHMP found that EllaOne demonstrates a safety profile similar to that of levonorgestrel-containing emergency contraceptives, which are already available without a prescription in 23 European countries.
The EMA states that the drug works best when taken within 24 hours of unprotected sex or contraceptive failure. “Removing the need to get a prescription for this drug should speed up women’s access to it and therefore increase its effectiveness,” it adds.
The CHMP recommendation will now be put before the European Commission for a legally binding decision.
The Royal Pharmaceutical Society (RPS) has welcomed the change. “This reclassification is a benefit to public health as it widens the options for women at risk of unplanned pregnancy while maintaining professional standards of provision,” says RPS president Ash Soni.