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

§ 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

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

for the registration of a traditional herbal medicinal product? 3. Under which conditions can a medicinal product be registered in accordance with Article 12 AMG? 4. What is a ‘corresponding’ herbal medicinal [...] exclusively designed for administration in accordance with a specified strength and posology. A corresponding product has been in medicinal use throughout a period of at least 30 years, including at least 15 years [...] No additional demonstration of the traditional use is required when a reference is made to a Community Monograph according to Article 16(h)3 of Directive 2001/83. For combinations with vitamins or minerals

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Referenced at:

• Tissue vigilance

it is not always possible to check all content to which a link has been created on a case-by-case basis. The pages for consumers were prepared in a way that is easy for laypeople to understand with AI support [...] but are also intended to encompass the diversity of a group of people. Where it is emphasized that all other gender identities should also feel welcome, a colon is now used (e.g., Mitarbeiter:innen). In this [...] types are automatically removed from the email and placed in a quarantine directory. In this case, both the sender and the recipient receive a notification. The following file types as attachments are classified

gemäß § 18a (1) Arzneimittelgesetz (AMG) I.1.a als erstzulassender Staat (Reference Member State - RMS) Update I.1.a.1 bei neuem Wirkstoff 42.463 EURO I.1.a.2 bei bekanntem Wirkstoff 32.415 EURO I.1.a.3 Repeat [...] Zulassung im nationalen Verfahren I.3.a Zulassung gemäß § 9a AMG I.3.a.1 bei neuem Wirkstoff 11.562 EURO I.3.a.2 bei bekanntem Wirkstoff 7.563 EURO I.3.b Zulassung gemäß §10a AMG (bibliographische Antragstellung) [...] klinischen Prüfung nach § 37a AMG oder § 40a MPG 538 EURO XII.5 Meldung einer NIS gemäß § 2a Abs. 3 AMG 648 EURO XII.6 Meldung eines Compassionate use Programms gemäß § 8a AMG XII.6.a unter Vorlage eines Gutachtens

Referenced at:

• Official announcements

Austria for the issuance of a CPP (Certificate for a Pharmaceutical Product) be reported? 23. What is to be done in case of a marketing cessation (temporary or permanent) for a medicinal product with an [...] to set a quota for the goods in stock in order to ensure supply and avoid stockpiling or parallel exports? In the case of a domestic quota of a prescription-only medicinal product for human use, a shortage [...] submit a statement of facts to medicineshortage@basg.gv.at . 24. Is a shortage to be notified if there is a temporary or permanent marketing cessation? No shortage notification is necessary for a permanent

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

es: The death of a patient, user or other person, the temporary or permanent serious deterioration of the health of a patient, user or other person, A serious public health hazard. A corrective action [...] action to eliminate the cause of a potential or existing noncompliance or other adverse situation. A field safety corrective action means a corrective action taken by a manufacturer for technical or medical [...] permanent serious deterioration of a patient's, user's or other person's state of health a serious public health threat If there is a suspicion of counterfeiting of a medical device, this must be reported