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Olha Demianiuk

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Ukraine has adopted the new law on pharmaceuticals (“Law”) that fundamentally changes the regulatory framework for pharmaceuticals. The Law is largely based on EU laws, although certain provisions, including as regards parallel importation of pharmaceuticals and regulatory data protection, are not aligned with EU laws and may create hurdles for companies operating in the Ukrainian market. The Law will be enacted within 2.5 years after the expiry/lifting of martial law. In this video, we present these and…

In brief In its decision of 12 September 2022 (C-1256/2020), the Swiss Federal Administrative Court (FAC) confirmed that interpretive software that uses indicators such as calendar days and body temperature to monitor fertile and infertile phases of a menstrual cycle to achieve natural conception or prevent undesired pregnancy, qualifies as a medical device. This means that such software is subject to a conformity certification procedure with a notified body. In its reasoning, the FAC primarily focused…