place a product on the market may submit an application to the Federal Office for Safety in Health Care (BASG) to determine whether this product falls within the definition of a medicinal product or a veterinary [...] Section 49a AMG or Section 2 (5) TAMG. Alternatively, persons wishing to place a product on the market can submit an informal enquiry to BASG by e-mail , which is answered by e-mail without a formal expert [...] BGBl. I 122/2021, as amended. We would like to point out that a fee-based application for qualification/classification can only be made by a manufacturer or authorised representative legally based in Austria

Diese Gebührenverordnung findet Anwendung auf alle Anbringen, die ab dem 01.01.2018 beim BASG eingegangen sind.

Referenced at:

• Fees

already undergone a readability test? 2.2. Does a readability test have to be performed when a Package Leaflet is adapted to the new QRD template? 3. Does the Package Leaflet (PL) of a new application for [...] 21 KB 21/07/2021 6. Does a certain type of readability test have to be performed? No, but the application dossier must contain a description of the test and a justification why a particular type of test [...] be documented in the results report. 2.2. Does a readability test have to be performed when a Package Leaflet is adapted to the new QRD template? No, if a readability test has been performed previously

- 15 344 16 - 17 323 18 - 44 26.397 45 - 64 15.814 65 - 75 2.309 über 75 1.598 1.650 92 344 323 26.397 15.814 2.309 1.598 0 5.000 10.000 15.000 20.000 25.000 30.000 unbekannt 5 - 11 12 - 15 16 - 17 18 - [...] https://info.gesundheitsministerium.at https://www.ages.at/mensch/krankheit/krankheitserreger-von-a-bis-z/coronavirus#c12444 https://info.gesundheitsministerium.at/ Bericht über Meldungen vermuteter [...] ung der Personen mit vermuteten Nebenwirkungen Geschlecht Anzahl Personen Weiblich 32.319 Männlich 16.052 divers/inter/offen/unbekannt 156 Anzahl Meldungen von vermuteten Nebenwirkungen Tabelle 3. Anzahl

Referenced at:

• Reports COVID-19 Vaccination

Current information from the meeting on 16.08.-18.08.2021: special issue Ipilimumab

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

definition of a gene therapygenetically modified organism In case of CUP with a medicinal product that fulfilsfulfills the definition of a gene therapy or with a medicinal product that constitutes a genetically [...] use of a non-licensed medicinal product or a medicinal product outside the limitations of the SmPC in a non-interventional study is no possible according to the definition in § 2a para 3 AMG. § 2a para 3 [...] According to § 8a paragraph 2 AMG the applicant for a CUP can either be a manufacturer, if also the sponsor of approved clinical trials for the respective medicinal product, or the applicant for a marketing

Referenced at:

• Compassionate use/Named Patient Use

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

zur Art der Spende ............................................................................... 16 3/108 Tabellenverzeichnis Tabelle 1: Übersicht der Aktivitäten der Gewebebanken „Muskuloskelettales [...] Tabelle 11: Angaben zu den Spenden .................................................................. 16 4/108 Abkürzungsverzeichnis AGES AT ATMPs BASG BGBl DLI ET EWR GSG ICSI Österreichische Agentur für [...] Zellen österreich- weit. 6/108 Rechtliche Grundlagen Das Gewebesicherheitsgesetz (GSG) sieht gemäß § 16 (1) vor, dass Gewebebanken nach dem Stand der Wissenschaft entsprechende Dokumentationen über ihre

Referenced at:

• Tissue vigilance

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