The Austrian Medicines Act (“Arzneimittelgesetz”) regulates under § 16c. (1): "The marketing authorisation holder or the holder of a registration must ensure that the package leaflet are available at the

e attribute must have a value equal to the current sequence. P/F Refer to EU m1 specification. When submitting a first submission initialising a regulatory activity or proving a reformatted application [...] stability-data-var.pdf 32a-app 32a1-fac-equip manufacturer optional folder facilities-and-equipment-report.pdf 32a2-advent-agent substance optional folder adventitious-agents-report.pdf 32a3-excip-substance multiple [...] May-24 • eCTD Validation Criteria 16.BP11 - New B/P validation criteria added 16.3 - updated 15.BP1 - updated 9.9 - Clarification added in the comment • "Files and Folders Q&A" sheet updated (removed reference

Referenced at:

• AGES eValidator

Recall due to deviations from the specified values regarding appearance and pH value

advice meeting is scheduled for a maximum of 2 hours. The meeting will be chaired by a BASG representative. After a round of welcome and introduction, the applicant shall give a presentation of the background [...] applying for Scientific Advice Item 5 If the application is submitted by a legal representative of the Applicant (e.g., a consultant), a letter of authorisation specific to the consultant and procedure in question [...] application form, the applicant is asked to attach a document containing a List of Questions, including justifications of the applicant’s positions. A template for this List of BASG / Austrian Medicines

Referenced at:

• Scientific advice by BASG

granted as a temporary exemption for a group of (unnamed) patients if the medicinal product in question meets the following criteria: the medicinal product is used to treat, prevent or diagnose a chronic [...] disability or a life-threatening disease, the disease cannot be treated satisfactorily with approved and available authorised medicinal products, based on the scientific data provided, there is a realistic [...] is either already in a centralised marketing authorisation procedure in accordance with Article 6 of Regulation 726/2004/EC or it is in clinical trials in the European Union or a third country. Distinction

pränatalen Screening eines vom Spender gezeugten Fötus, eine 16p13.11-Duplikation entdeckt wurde. Der Spender VIND weist eine Duplikation am 16p13.11p12.3 auf, welche mit unterschiedlichen klinischen Merkmalen [...] Mikulits Nina am 9.8.2023 mailto:gewebevigilanz@basg.gv.at 2023-08-09T12:59:30+0200 Informationen zur Prüfung finden Sie unter http://www.signaturpruefung.gv.at

Referenced at:

• Cryos International-Aarhus - Donor VIND

From 1 January 2007 to23 March 2016, Zika virus transmission was documented in a total of 61 countries and territories.

Referenced at:

• ZIKA VIRUS MICROCEPHALY AND GUILLAIN-BARRÉ SYNDROME

Traisengasse 5 l 1200 Wien l ÖSTERREICH l www.basg.gv.at F_INS_VIE_CLTR_I125_05 Gültig ab: 16.01.2025 2 von 5 Salzburg A Phase 3 Randomized, Open-Label, Multicenter Study of Zanubrutinib (BGB 3111) Plus Anti-CD20 [...] www.basg.gv.at F_INS_VIE_CLTR_I125_05 Gültig ab: 16.01.2025 4 von 5 vaccine, when administered to healthy adults aged of 18-75 years old. ACcomplisH: A Phase 2, multicenter, double-blind, randomized, placebo- [...] CLTR_I125_05 Gültig ab: 16.01.2025 5 von 5 Pancreatic Ductal Adenocarcinoma (ASPIRE). Hämatologie und internistische Onkologie, Feschnigstr. 11, 9020 Klagenfurt am Wörthersee A Phase 3, Single-Arm, Multicenter

Referenced at:

• Good Clinical Practice

require a license, if... 2. a medical doctor, dentist or veterinarian, licensed for independent exercise of profession in Austria, confirms, that the medicinal product is urgently required to avert a life [...] intended to facilitate the urgently needed treatment of a specific patient to avert a life-threatening or chronically debilitating situation. A Cave: English translations of Austrian legal documents are [...] , in contrast, provides a framework where data (primarily on safety) on the medicinal product, can be collected (according to a treatment plan) after approval by the Agency. A Compassionate Use Program

Referenced at:

• Compassionate use/Named Patient Use

Recall due to incorrect expiry date