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Sweden: Administrative Court Upholds Prohibition on Sale of COVID-19 Test Kits

(May 8, 2020) On May 4, 2020, the Administrative Court of Uppsala ruled that sales of Zandcell AB’s COVID-19 test kits were prohibited in Sweden because the producer had not proven that the product met the legal requirements for medical devices under Swedish and European Union law. (Uppsala Administrative Court, Decision No. 240-20 (May 4, […]

New Zealand; Singapore: New Declaration on Trade in Essential Goods for Combating the COVID-19 Pandemic

(Apr. 17, 2020) On April 15, 2020, the governments of New Zealand and Singapore “launched a new trade initiative to ensure supply chain connectivity and the removal of blockages to trade in a list of essential products that includes medicines, medical and surgical equipment.” The initiative builds on a joint statement by the two countries in […]

Italy: Law to Establish Compliance with European Union Obligations Enacted

(June 17, 2019) On May 25, 2019, new legislation establishing measures for Italy to comply with obligations arising from its European Union (EU) membership was enacted in Italy. (Law No. 37 of May 3, 2019, Provisions for Compliance with the Obligations Deriving from Italy’s Membership in the European Union – European Law 2018) (Law No. […]

Sweden: Supreme Administrative Court Declares E-Cigarettes Not Medical Devices

(Feb. 26, 2016) On February 17, 2016, the Swedish Supreme Administrative Court issued a decision in which it found that e-cigarettes are not medical devices and therefore are not regulated by the Läkemedelsverket (Medical Products Agency). (Supreme Administrative Court 2016-02-17 ref 1385-15 (Case 1385-15), download at Press Release, E-cigaretter är inte läkemedel (Feb. 17, 2016), […]