European Medicines Agency released recommendations on the classification status of ellaOne
The European Medicines Agency (EMA) on its webpages has published a press release on the recommendations that will be forwarded to the European Commission for final Decision concerning the classification status of ellaOne. The entire press release is accessible below.
The European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) has endorsed a recommendation on the change in classification of the emergency contraception ellaOne (ulipristal acetate) from the prescription only medicine to OTC. This means that this medicine may be available in the EU without prescription.
ellaOne is an emergency contraception used to prevent pregnancy if taken within 120 hours (five days) after an unprotected intercourse or failure in contraception. This medicine prevents or delays ovulation. The best effect is achieved if taken within 24 hours. The alleviation of the prescription regime for this medicine should facilitate access to this medicine for women and therefore increase its efficacy.
Based on the review of the available data, the CHMP concluded that ellaOne could be used safely and efficaciously without medical prescription. ellaOne was authorised in 2009 and comprehensive amount of information on its benefits and risks have been collected and investigated. The safety profile of this medicine is has been compared with profiles of levonorgestrel-containing emergency contraceptives which are the most commonly used contraceptives in the EU. Levonorgestrel-containing emergency contraceptives are in the most of the EU countries available without prescription and authorised for use within 72 hours after an unprotected intercourse or failure of contraception.
This CHMP recommendation will now be forwarded to the European Commission for adoption of a legally binding decision.
The marketing authorisation holder for ellaOne is Laboratoire HRA Pharma.This is a type II variation, where the marketing authorisation holder applies for a change in classification of ellaOne in the EU, or a change in dispensing status from "prescription” to "without prescription”
Levonorgestrel-containing emergency contraceptives, i.e. Norlevo, Levonelle and Postinor are classified as OTC. in 23 European countries. The exception is Malta, where emergency contraceptives are not placed on the market and the following countries where levonorgestrel-containing emergency contraceptives are available only as prescription medicines: Croatia, Germany, Greece, Hungary, Italy, Liechtenstein and Poland.
When reviewing the change in classification status from prescription to non-prescription, the role of the EMA is to assess whether the medicine may be used in a safe and efficacious manner and to forward to the European Commission a recommendation on the change in classification status. In case of a positive decision of the European Commission, this change in classification status from prescription to non-prescription should generally be implemented in all EU member states. Any exception as regard the non-prescription status of this medicine falls within the scope of member states.