In Germany, do hand disinfectants for hygienic and surgical hand disinfection have to be approved as medicinal products or may biocidal products also be used?

In the European Economic Area – including Germany – hand disinfectants containing 2-propanol that have not been approved as medicinal products by the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) may also be used for hygienic and surgical hand disinfection.

For hand disinfectants containing 2-propanol, the European Union resolved to classify them as biocidal products in the Commission Implementing Decision 2016/904 of June 8, 2016.

1 Durchführungsbeschluss (EU) 2016/904 der Kommission vom 8. Juni 2016 gem. Art. 3 Abs. 3 der Verordnung (EU) Nr. 528/2012 des Europäischen Parlaments und des Rates über 2-Propanol-haltige Produkte für die Händedesinfektion. ABl. L 152/45.

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