The applicants see the procedures in the eService portal and should enter an e-mail address to be actively informed about the completion of the procedure. Otherwise, the respective procedures can be found [...] (available only in German). ). If necessary, the table data property "Repeat headings" must be activated for column headings in the Word document. In the german-speaking area, tables are read from top

quality of medicinal products and, with this knowledge, actively supports applicants in the approval of their medicinal products. BASG actively invests in the know-how of its employees. Regular training [...] consistently high level. Additionally, Austria actively participates in shaping relevant committees. Austria is strongly participating in decisions and activities of the Coordination group for Mutual recognition [...] to the assessment of Certificates of Suitability (CEPs) and a key member in the development of the Active Substance Masterfile (ASMF) repository. Furthermore, the well-established Case Managers ensure prompt

Devices Agency (AGES Medizinmarktaufsicht) during the procedure? Do I have to check the eService actively for new documents or do I receive an email as soon as a new document is uploaded? Is the communication [...] as the texts can be submitted to several member states at once. Do I have to check the eService actively for new documents or do I receive an email as soon as a new document is uploaded? A notification

manufacture or control medicinal products. The activities have to encompass the qualitative analysis of medicinal products, of quantitative analysis of active substances and of the testing required to ensure [...] training or the qualified activity is equivalent to the requirements in § 8 para 2 or § 9 para 2 AMBO 2009 . Note: If the relevant professional training or qualified activity was acquired or carried out [...] processes, stores or distributes human blood or blood components without any further manufacturing activities must have a Responsible Person at its disposal. Therefore, according to § 5 (4) QS-VO Blut, changes

facilities Radioactive irradiation In Article 5(1) of Directive 2002/98/EC it is laid down that activities relating to the collection and testing of human blood and blood components, whatever their intended

example, the extent of actual pharmacovigilance activities in Austria (number of cases/PSUR statistics), requirements from RMPs, service provider activities, etc. Another selection criterion for an inspection [...] Pharmacovigilance Practice (GVP) modules that regulate the implementation of pharmacovigilance activities. The first GVP modules came into force in July 2012, and further modules were published in the

The manufacturer informed its customers on 04 December, 2019, that the stated value of the active pharmaceutical ingredient content was too high.

Referenced at:

• Colistinsulfat

single assessment (PSUSA) procedure. During a PSUSA procedure PSURs of medicines containing the same active substances or combinations, even if they are subject to different marketing authorisations and are

Italy is currently experiencingfour clusters of autochthonous chikungunya cases in the cities of Anzio,Latina and Rome in the Lazio region,and the city of GuardavalleMarinain theCalabria region. Autochthonous transmissionof mosquito-borne infectionsis not unexpectedin areas where Aedes albopictusmosquitoes are established and at a time when environmental conditions are favouring mosquito abundance and activity.

Referenced at:

• Clusters of autochthonous chikungunya cases in Italy: First Update

Two related clusters involving autochthonous transmission of chikungunya virus have been detected in the cities of Anzio and Rome, two areas located 60 km apart in the Lazio region of Italy. Transmission of this type, in areas where Aedes albopictusmosquitoes are established and at a time when environmental conditions are suitable for increased mosquito abundance and activity, is not unexpected.

Referenced at:

• Clusters of autochthonous chikungunya cases in Italy