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

The fees valid on the date of application at BASG after 01.01.2020.

Referenced at:

• Fees

The fees valid on the date of application at BASG after 01.01.2019.

Referenced at:

• Fees

The fees valid on the date of application at BASG after 01.07.2020.

Referenced at:

• Fees

on gi os a Ti bi a ko m pl et t Ti bi a D ia ph ys e Ti bi a Sp on gi os a Kn or pe l, Ch on dr oz yt en Se hn en , Bä nd er Fa sz ie n M us ke lz el le n Sc hä de l- ka lo tt en An de re s A.ö. Krankenhaus [...] al s Fe m ur D ia ph ys e Fe m ur Co rt ic al is Fe m ur Sp on gi os a Ti bi a ko m pl et t Ti bi a D ia ph ys e Ti bi a Sp on gi os a Kn or pe l, Ch on dr oz yt en Se hn en , Bä nd er Fa sz ie n M us ke [...] al s Fe m ur D ia ph ys e Fe m ur Co rt ic al is Fe m ur Sp on gi os a Ti bi a ko m pl et t Ti bi a D ia ph ys e Ti bi a Sp on gi os a Kn or pe l, Ch on dr oz yt en Se hn en , Bä nd er Fa sz ie n M us ke

Referenced at:

• Tissue vigilance

Assessment of the Advisory Board on Classification regarding well & active Eukalyptus-Balsam für Babys und Kleinkinder (German only)

Referenced at:

• Decisions of the AGBR

Assessment of the Advisory Board on Classification regarding Akuz (German only)

Referenced at:

• Decisions of the AGBR

Zika virus infection outbreak, Brazil and the Pacific region

Referenced at:

• Zika virus infection outbreak, Brazil and the Pacific region

§ 07a SLITone ULTRA Alternaria alternata ALL-0071 ALK-Abello A/S 1376017 4/16/13 Einstimmig Bescheid Zulassung nach § 07a SLITone ULTRA Ambrosia artemisiifolia ALL-0070 ALK-Abello A/S 1375518 4/16/13 [...] national Atenolol 1A Pharma 100 mg - Filmtabletten 1-24386 1A Pharma GmbH 1413624 6/13/13 Einstimmig Bescheid Zulassungsverlängerung national Atenolol 1A Pharma 50 mg - Filmtabletten 1-24385 1A Pharma GmbH 1413621 [...] Zulassung nach § 09a (VOLL) Rhidate 4 mg Retardkapseln 1-31884 Geymonat SpA 1388605 5/7/13 Einstimmig Bescheid Zulassung nach § 09a (VOLL) Rhidate 2 mg Retardkapseln 1-31883 Geymonat SpA 1388237 5/7/13 Einstimmig

Referenced at:

• BASG approval procedure

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