Symptoms associated with Zika virus (ZIKV) infection are generally mild and most people who become infected do not develop any symptoms. However, since the 2015‒2017 epidemic in the Americas, ZIKVhas been recognised asbeingassociated with severe neurological disorders

Referenced at:

• Zika virus transmission worldwide

European Union/European Economic Area(EU/EEA)Member States should consider a range of mitigation measures

Referenced at:

• Zika virus disease epidemic ninth update

§ 11a AMG 1.000 EURO IV.6 Registrierung von traditionellen pflanzlichen Arzneispezialitäten im dezentralen Verfahren oder gegenseitigen Anerkennungsverfahren gemäß § 18a AMG mit Österreich IV.6.a IV.6 [...] 6.a.1 IV.6.a.2 als erstzulassender Staat (Reference Member State - "RMS") wenn einer gemeinschaftlichen Pflanzenmonographie nach Artikel 16h Abs. 3 der Richtlinie 2001/83/EG entsprochen wird wenn nicht [...] 14 wird wie folgt geändert: VII.3 Betriebsüberprüfung gemäß §§ 59a, 67 AMG, § 68 MPG, § 26 GSG, § 18 BSG oder § 6a Abs. 1b GESG VII.3.a im Inland pro begonnenen Inspektionshalbtag 1.000 EURO VII.3.b im

Referenced at:

• Official announcements

pursued by the amendment with a view to providing clarity on the information sharing obligations introduced in Article 10a. PART A – GENERAL 1. From when does the new Article 10a of the MDR/IVDR apply? The [...] in the context of a supply interruption where the manufacturer does not directly supply to the health institution: On 1 May 2025, a manufacturer of a CE-marked pacemaker confirms that a supply interruption [...] Regulatory o A loss of compliance with a condition in Article 120 of the MDR / Article 110 of the IVDR to place a legacy device7 on the market o Delay in certification of the type of device (including a corresponding

Referenced at:

• Manufacturer and representative

The preparations Xenical and alli (active ingredient: orlistat) have been approved throughout Europe since 1998 and 2007, respectively, for weight reduction in adults who are overweight (body mass index BMI > = 28 kg/m2 in conjunction with a slightly…

licence for a proprietary medicinal product transferable? No. In that case, a new application for a marketing authorisation for parallel imports shall be submitted. 4. A parallel import licence for a product [...] at a given time? If so, at what time? 2. Are parallel imports subject to PSUR? 3. Is the parallel import licence for a proprietary medicinal product transferable? 4. A parallel import licence for a product [...] the German "Besonderheitenliste"? In Germany, for example, a lactose warning must be affixed. 13. The primary container (e.g. a syringe) is in a closed tray. Must the tray be opened to open the primary container

products with a new marketing authorisation 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 [...] epizootic diseases according to §16 Act on epizootic diseases (Tierseuchengesetz RGBl. Nr. 177/1909 ). How is the procedure for receipt of a batch release certificate? If a batch shall be marketed the applicant [...] by means of novel techniques or which are new to a particular manufacturer. These proprietary medicinal products shall be subject to batch release for a transitional period to be determined. These medicinal

Dienstabzeichens für Kontrollorgane des Bundesamtes für Sicherheit im Gesundheitswesen Auf Grund des § 6a Abs. 5 des Gesundheits- und Ernährungssicherheitsgesetz – GESG, BGBl. I Nr. 63/2002, zuletzt geändert [...] Inkrafttreten § 2. Diese Verordnung tritt mit 01. März 2012 in Kraft. Müllner Türk Berger Wien, am 16. Februar 2012 Anlage

Referenced at:

• Legal ordinances of BASG

Zusammenfassung der jährlichen Berichterstattung über ernste unerwünschte Reaktionen und Zwischenfälle bei Blut und Blutbestandteilen (2020) - Bericht nur auf englisch verfügbar

Referenced at:

• Haemovigilance

Up-to-date information from the 11.12.-14.12.2023 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.