Due to the revision of the therapeutic products legislation and the complete revision of the Medicinal Products Licencing Ordinance (implementation scheduled for 1 January 2019), an adaptation of the operating licences issued by Swissmedic is necessary. For activities with blood and blood components, from 1 December 2018 the general application forms for medicinal products (Basisformular and Zusatzblatt Arzneimittel) have to be used.
Authorisations
Authorization for importing individual batches
Since 01.01.2023, in addition to issuing individual import licenses for blood, blood products and immunological medicinal products for humans, Swissmedic is also responsible for issuing individual import licenses for immunological medicinal products from animals.
Diese Wegleitung bezeichnet die für die Untersuchung von Spenderblut und Plasma geeigneten Tests, umschreibt die technischen Anforderungen für die Durchführung von Tests mittels Nukleinsäure-Amplifikationstechnik (NAT) und verweist auf Empfehlungen zur Überprüfung der Kompatibilität von labilen Blutprodukten mit der Empfängerin oder dem Empfänger.
In order to standardise document names, the published "Administrative Ordinances" (VV) are being replaced by "Guidance documents" (WL). The function and effects of the document are not changed as a result of the name change.
During the transitional phase, small adjustments to existing Administrative Ordinances will continue to be made and will be published as such, with the corresponding information. Over time, however, Administrative Ordinances will be successively phased out.
We thank you for your understanding and would be pleased to respond to any questions or comments at qm@swissmedic.ch.