specifically provide a definition for the legal representative, nevertheless the legal interpretation is in analogy to that of the medicinal product legislation (AMG): §2a (16) AMG A Sponsor is a natural or legal [...] investigated in the context of a clinical trial for a medicinal product, or a medical device/IVD is being used without CE mark or outside its intended purpose (see 1.2). If a device is investigated where [...] and requires approval. 5.4.2. Restart The restart of a CI/PS after a temporary halt constitutes a substantial amendment and requires the submission of a substantial amendment to the BASG using the amendment

Referenced at:

• Clinical investigations with medical devices

Dem Bundesamt für Sicherheit im Gesundheitswesen wurde von der ECDC (European Centre for Disease Prevention and Control) mitgeteilt, dass in Serbien in der aktuellen Saison insgesamt 16 humane WNV-Infektionen verzeichnet wurden.

Referenced at:

• West Nile Virus (WNV) - Serbia

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

Reaktionen Reaktion BioNTech/Pfizer Moderna AstraZeneca Jannsen Fieber 1.936 397 10.079 16 Kopfweh 2.161 360 9.433 16 Schmerzen an der Impfstelle 1.577 434 6.244 8 Müdigkeit 1.643 305 5.104 9 Gelenkschmerzen [...] Nebenwirkungen Alter in Jahren Anzahl Personen unbekannt 521 über 75 753 65-75 756 45-64 7.968 18-44 14.043 16-17 32 Geschlechterverteilung Abbildung 2. Geschlechterverteilung der Personen mit vermuteten Nebenwirkungen [...] Geschlechterverteilung der Personen mit vermuteten Nebenwirkungen Geschlecht Anzahl Personen Weiblich 16.678 Männlich 7.313 unbekannt 82 Bericht über Meldungen vermuteter Nebenwirkungen nach Impfungen zum

Referenced at:

• Reports COVID-19 Vaccination

e or a certificate of marketability is required, a movement declaration is required. A Named Patient Use always refers to a previously known patient. This reference must be proven. In contrast, a Compassionate [...] for named patient use versus compassionate use If a physician requires a medicinal product for a Named Patient Use that is not approved in Austria, a distinction must be made: Unpredictable acute need [...] entitled to sell pharmaceutical products in a contracting party of the EEA if they have a licence in accordance with § 63 AMG or have the equivalent authority of a member state. Conditions for import or shipment

Formular zur Meldung eines Qualitätsmangels durch Zulassungsinhaber; [Aktualisiert: 12.06.2024]

Referenced at:

• Quality defects

Precautionary batch recall, as there may be glass splinters in the 60 ml bottles

Zika virus infection outbreak, Brazil and the Pacific region

Referenced at:

• Zika virus infection outbreak, Brazil and the Pacific region

do I receive an email as soon as a new document is uploaded? A notification email is sent when a procedure is started, when a new communications entry is creaed and when a procedure is closed. The receiver [...] types should be used? 11. How can I provide a consultant with a restricted access to the eService "Authorisation and Lifecycle MP"? 12. Does my company need a local contact in Austria to register for the [...] data types should be used? Following a variation, texts should be uploaded as Word files, with changes highlighted accordingly. 11. How can I provide a consultant with a restricted access to the eService

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Referenced at:

• Tissue vigilance