For both products, the license requires the pharmacist to make sure the product is suitable for the patient and that the patient understands how to correctly use it. Previously, such a conditional license has only been granted to the so called morning after pill.
Fimea predicts that these conditional OTC switches will be a growing category in the future. This would indicate that other applications are being handled by the authority.
In the beginning of 2015, Fimea launched a self-care programme, which aimed at making self-care more available to patients without compromising patient safety. In the programme Fimea states that the growing pressure on the health care system requires the authority to also look into making OTC’s more available to patients.
As a result of the programme, PIF’s member companies have reported that discussions with the Fimea around switch applications are now more productive. Also Fimea has stated, that the quality of switch application has somewhat improved.