sequences within an ongoing regulatory activity, the related sequence attribute should be populated with the number of the sequence that started this regulatory activity. Due to some inconsistencies of im [...] P/F Refer to EU m1 specification. When submitting a first submission initialising a regulatory activity or proving a reformatted application, the related sequence attribute should be populated with the [...] is the intent to assure the INN data field is completed. It is strongly recommended to re-use the active ingredient name as of the application form. Separation of multiple names by colon. 14.9 Envelope

Referenced at:

• AGES eValidator

The 2016/2017 yellow fever outbreak in Brazil was declared over in September 2017. The upsurge of human cases since December 2017 and non-human primate epizootics since September 2017 indicates a resurgence of the circulation of yellow fever virus in Brazil, and more particularly in São Paulo State.

Referenced at:

• Outbreak of yellow fever in Brazil

The 2016/2017 yellow fever outbreak in Brazil was declared over in September 2017. The upsurge of human cases since December 2017 and non-human primate epizootics since September 2017 indicates a resurgence of the circulation of yellow fever virus in Brazil, and more particularly in São Paulo State.

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

Referenced at:

• Fees

Zusammenfassung der jährlichen Berichterstattung über ernste unerwünschte Reaktionen und Zwischenfälle bei Blut und Blutbestandteilen (2016) - Bericht nur auf englisch verfügbar

Referenced at:

• Haemovigilance

Advice) V.3.a bei im EWR neuen Wirkstoffen (new active substances), sowie Biosimilars 9138 EURO V.3.b bei im EWR bekannten Wirkstoffen (existing active substances) 5712 EURO V.4 Labortechnische Analysen

Referenced at:

• Official announcements

As of November 1, 2017, parts of the Mutual Recognition Agreement (MRA) between the EU and the US entered into force. This agreement updates the original, unratified 1998 agreement and enables mutual recognition of inspection results (Good…

Italy is currently experiencing four clusters of autochthonous chikungunya cases in the cities of Anzio, Latina and Rome in the Lazio region, and the city of Guardavalle Marina in the Calabria region. Autochthonous transmission of mosquito-borne infections is not unexpected in areas where Aedes albopictus mosquitoes are established and at a time when environmental conditions are favouring mosquito abundance and activity.

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

Five events of local transmission of malaria have been reported recently in the EU. Three of these events were associated with either mosquito-borne transmission around an imported case (introduced malaria) or an imported infected mosquito (airport malaria),in Greece and northern Cyprus (P. vivax), and in France (P. falciparum),and two were most likelyassociated with nosocomial transmission of P. falciparum,in Italy and in Greece,either mosquito-borne or iatrogenic.

Referenced at:

• Multiple reports of locally-acquired malaria infections in the EU