Context sidebar

Information

18.07.2018

Adaptation of the Guidance document «Time limits for authorisation applications» to be submitted immediately

ZL000_00_006e_WL

10.07.2018

Changes to the Guidance document on time limits for authorisation applications

The changes to the Guidance document take immediate effect.

11.06.2018

Anpassung der Merkblätter „Erläuterungen zur Patienteninformation“ und „Erläuterungen zur Fachinformation“ per sofort

ZL000_00_016d_MB / ZL000_00_017d_MB

04.06.2018

Adaptation of the table overview “Countries with comparable control of human medicinal products” to be submitted immediately

ZL000_00_009e VZ

28.05.2018

Modifications to guidance document "Formal requirements" and Modifications to the table "Documents to be submitted"

ZL000_00_001e_WL / ZL000_00_002e_VZ

01.05.2018

Adaptation of the guidance document enter into force immediately

ZL000_00_015e_WL

13.03.2018

Adaptation of the table overview of documents to be submitted immediately

ZL000_00_002e_VZ

13.03.2018

Adaptation of the form Variations requiring notification immediately

ZL301_00_001e_FO

13.03.2018

Adaptation of the Guidance document Formal requirements immediately

ZL000_00_001e_WL

09.02.2018

Modifications to guidance document "Formal requirements" and Modifications to the table "Documents to be submitted"

ZL000_00_001e_WL / ZL000_00_002e_VZ

09.02.2018

Anpassung des Merkblatts Zulassung Musterpackung im Meldeverfahren

ZL305_00_001d_MB

06.02.2018

Adaptation of the guidance document formal requirements enter into force immediately

ZL000_00_001e_WL

31.01.2018

Adaptation of the form application for extension of authorisation enter into force immediately

ZL201_00_001e_FO

16.01.2018

Adaptation of the form Application for Authorisation / Variation human medicines enter into force immediately

ZL000_00_003e_FO

01.01.2018

Updating of guidance document and FAQ document "Authorisation Biosimilar"

ZL101_00_003e_WL

Supplementary information

Zuteilung IT-Gruppen zu Case Management (XLS, 274 kB, 31.05.2018)

Top of page