Gemäß § 8. (2) Gewebeviglianzverordnung ist das BASG dazu verpflichtet, die von der Europäischen Kommission verfasste Zusammenfassung der von den Mitgliedstaaten eingegangenen Berichte zu veröffentlichen (Bericht nur auf englisch verfügbar).

Referenced at:

• Tissue vigilance

products with a new marketing authorization or produced by a novel technique or a technique that is novel for a specific manufacturer. These medicinal products are subject to batch release for a specified [...] (OMCL)? 2. Are there any exemptions to the requirement of official batch release? 3. Importation from a third Country: 1. Which medicinal products require official batch release by the Official Medicines [...] vaccines, toxins, sera or allergens used for defence against notifiable epizootic diseases according to §16 Act on epizootic diseases (Tierseuchengesetz RGBl. Nr. 177/1909). In accordance with Regulation on

Press Release - Kick Off Meeting CHESSMEN, Rome, 10.02.2023

Referenced at:

• European Network

below: Application: Conformity assessment bodies that intend to become a notified body must submit an application to the BASG to initiate a designation procedure. This application must contain all the necessary [...] assessment: An important step in the designation procedure is the on-site audit. A team of experts from the BASG, together with a team of experts assembled by the European Commission, carries out an on-site [...] applications for designation, the documents MDCG 2021-15 together with MDCG 2021-17 (MDR) and/or MDCG 2021-16 together with MDCG 2021-18 (IVDR) must be submitted to medizinprodukte@basg.gv.at . In addition, the

Dem Bundesamt für Sicherheit im Gesundheitswesen wurde von der italienischen Behörde mitgeteilt, dass (zusätzlich zu den bereits bekannt gegebenen Regionen) in Barletta-Andria-Trani (Region Apulia), aufgrund der Auffindung von WNV NAT positive Pferden, für Spender von Blut und Blutkomponenten die ID WNV NAT Testungen eingeführt wurde.

Referenced at:

• WNV Update Italy

Given the current circulation of Zika virus,the evidence of an association between Zika virus infection during pregnancy and congenital malformations of the central nervous system (CNS),the association between Zikavirus infection and Guillain–Barré syndrome(GBS)and the risk of local vector-borne transmission in Europe during the 2016 summer season, EU/EEA Member States shouldconsider a range of mitigation measures.

Referenced at:

• Zika virus disease epidemic eight update

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Referenced at:

• Tissue vigilance

e/n - - 13 3 13 - - Pulmonalklappe/n - - 4 17 16 - - Gefäße 9 9 19 3 9 - Pericard - - - - - - - Anderes Gesamt : 17 16 - 5 - - - aufgeteilt in: Herz 17 16 - - - - - Pulmonalis- bifurkation - - - 5 8 - [...] Femur komplett 16 26 4 - - - 1 Femurkopf,- hals 1636 1620 392 582 429 - 94 Diaphyse - - 19 23 17 - 8 Corticalis - - 155 38 21 - 4 Spongiosa - - 2842 1211 8183 36 - Tibia: Tibia komplett 16 2 4 - - - 1 Diaphyse [...] Verteilung Endprodukt Ausfuhr Einfuhr Knochenmark 33 21 795 27 40 1 16 Periphere Blutstammzellen (PBSC) 900 609 7027 864 1333 6 58 Donorlymphozyten 16 13 456 18 102 2 6 Nabelschnurblut 1517 716 2998 23 666 4 19

Referenced at:

• Tissue vigilance

Dem Bundesamt für Sicherheit im Gesundheitswesen wurde von der dänischen Behörde mitgeteilt, dass sie von der dänischen Gewebebank Cryos International (DK257551) darüber informiert wurde, dass bei dem Spender 8632 das Asperger-Syndrom diagnostiziert wurde.

Referenced at:

• Cryos International – 8632

reduction of stock be reported multiple times per year? 16. How should a marketing authorisation holder proceed if they want to report, correct, or end a (repeated) temporary reduction of stock? 17. What happens [...] submitted from April 21, within a period of 14 days. Please note that in the event of a revision of the annex, the BASG will not notify marketing authorisation holders if a medicinal product is no longer [...] reporting are available in both German and English. 16. How should a marketing authorisation holder proceed if they want to report, correct, or end a (repeated) temporary reduction of stock? These functions