Verordnung des Bundesministers für Soziales, Gesundheit, Pflege und Konsumentenschutz, mit der die Verordnung betreffend COVID-19-Sonderregelungen für Medizinprodukte (COVID-19-MedizinprodukteV) geändert wird
379. Verordnung des Bundesministers für Soziales, Gesundheit, Pflege und Konsumentenschutz, mit der die Verordnung betreffend COVID-19-Sonderregelungen für Medizinprodukte (COVID-19-MedizinprodukteV) geändert wird
Auf Grund des § 81 Abs. 1 des Medizinproduktegesetzes, BGBl. I Nr. 122/2021, wird verordnet:
Die Verordnung betreffend COVID-19-Sonderregelungen für Medizinprodukte (COVID-19-MedizinprodukteV), BGBl. II Nr. 86/2021, wird wie folgt geändert:
1. § 5 erhält die Paragraphenbezeichnung ?§ 6.?; nach § 4 wird folgender § 5 eingefügt:
?§ 5.
(1) Apotheken sind im Zuge der Abgabe von kostenlosen SARS-CoV-2-Antigentests zur Eigenanwendung, die gemäß § 81 Abs. 4 des Medizinproduktegesetzes, BGBl. I Nr. 122/2021, in Verkehr gebracht werden, berechtigt, die Handelspackung zur Auseinzelung bzw. Stückelung zu öffnen und ausgeeinzelt bzw. gestückelt an den Anwender abzugeben. Diesfalls gelangen die Verpflichtungen für Hersteller nach diesem Bundesgesetz nicht zur Anwendung.
(2) Tests gemäß Abs. 1 dürfen in fremdsprachiger Kennzeichnung abgegeben werden, sofern dem Anwender die zugehörige Gebrauchsinformation in deutscher Sprache mitübergeben wird.
(3) Die Apotheke hat im Zuge der Abgabe sicherzustellen, dass alle zur Durchführung notwendigen Bestandteile des jeweiligen Test-Kits mit dem Test an den Anwender abgegeben werden. Weiters sind dem Anwender alle für die Nachverfolgung...
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