Further information regarding the implementation of Commission’s Decision on the reclassification status of ellaOne
The Agency for Medicinal Products and Medical Devices (HALMED) would like to offer further information regarding the implementation of Commission’s Decision on the reclassification status of ellaOne from prescription only to OTC.
Medicinal products for the Croatian market may be authorised, depending on the regulatory procedure type, either HALMED or the European Commission. ellaOne is authorised by the European Commission, via centralised procedure, where the EC authorises the medicinal products in all EU member states, based on the scientific assessment by the European Medicines Agency.
Under Article 4, Paragraph 4 of Directive 2001/83/EC, Commission’s Decision on the reclassification of ellaOne will not impact the implementation of the national legislation prohibiting or restricting sale, distribution or use of medicines such as contraceptives or abortive products. So, those EU member states where the distribution of contraceptives is limited by legislation to prescription only, are not obliged to follow Commission’s decision on the reclassification status (Rx-to OTC-Switch). Al other member states, not having this provision on prohibition or restriction in their national legislation, are required to implement Commission’s Decision.
This is exactly what HALMED posted on its webpages on 20 January 2015, where it was explicitly indicated that; "the implementation of this decision is planed gradually during 2015 in all EU member states, except in those, where distribution of contraceptive is by legislation required on prescription”, taking account that before coming into effect of this decision, ellaOne was being distributed in Croatia exclusively on prescription, but this was not stipulated by legislation.
Therefore, exactly opposite to the allegations in certain media, the European Commission in its answers to questions from delegates, confirmed the information on national exemptions that HALMED made publically available about, already in January 2015. However, as the Croatian legislation does not contain any provision prohibiting or restricting distribution of emergency contraceptives exclusively on prescription, Croatia is required to implement Commission’s Decision.
Also, on 22 April 2015, when we informed on our webpages on the beginning of distribution of ellaOne without prescription, we stated that Commission’s Decision is : "mandatory to all EU member states, including Croatia”, hence we even than were in the category of states not having other provisions stipulated by our national legislation and therefore obliged to implement Commission’s Decision.
Furthermore, opposite to certain media allegations, experts of the European Medicines Agency concluded that ellaOne is a contraceptive preventing pregnancy and not an abortive product. The mechanism of action of ellaOne is to prevent or delay ovulation and in case that the pregnancy has already occurred, ellaone will not disrupt it. Based on a thorough review of all benefits and risks of use of ellaOne, the European Medicines Agency concluded that this medicinal product may be used safely and efficaciously without medical prescription.