EU Commission releases "ellaOne" morning-after pill from prescription requirement
Measures at EU level The EU Commission has released the emergency contraceptive "ellaOne" (active ingredient: Ulipristal) from prescription-only status. In doing so, the Brussels-based authority has followed the recommendation of the European Medicines Agency (EMA), which had come out in favor of a release in November. This decision applies to all 28 EU member states. The "morning-after pill" containing ulipristal acetate was approved in 2009 in the central European approval procedure. Until now, it has only been available on prescription, unlike older levonorgestrel preparations, which have been available without prescription in Austria since 2009.
Situation in Austria
The Commission's implementing decision issued on 07.01.2015, which made the medicinal product "ellaOne 30 mg tablet" available without a prescription, has already been implemented by the Federal Office for Safety in Health Care due to the immediate effect of this decision.The requirement that a pre-existing pregnancy must be ruled out before use has also been restricted. Only in the event of delays in menstrual bleeding or if pregnancy symptoms occur must pregnancy still be ruled out before use.
The following important aspects must be observed for over-the-counter dispensing:
- An emergency contraceptive in no way replaces a regular contraceptive method.
- An existing pregnancy cannot be terminated by taking it.
- The "morning-after pill" does not provide protection against sexually transmitted diseases.
- Preventing pregnancy is not possible in every case, especially if there is uncertainty about the exact time of unprotected sexual intercourse.
- It is strongly recommended to be checked by a gynecological specialist.
Further information:
Implementing decision of the EU Commission dated 07.01.2015:http://ec.europa.eu/health/documents/community-register/html/h522.htm
Queries (specialist):
Dr. Christoph Baumgärtel, Tel.: 050555/36004
E-mail: christoph.baumgaertel@ages.at
Queries (for media):
Communications Management, Tel.: 050555/25000
E-mail: presse@ages.at
