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Information

12.06.2019

Adaptation of the Guidance document Temporary authorisation for human medicinal products HMV4

ZL109_00_001e_WL

12.06.2019

Adaptation of the Guidance document Fast-track authorisation procedure HMV4

ZL104_00_002e_WL

29.05.2019

Adaptation of the Guidance document Authorisation biosimilar HMV4

ZL101_00_012e_WL

09.05.2019

Adaptation of the Guidance document Variations and extensions HMV4

ZL300_00_001e_WL

09.04.2019

Adaptation of the Guidance document Orphan Drug HMV4

ZL100_00_002e_WL

09.04.2019

Modification of various documents relating to authorisation

ZL000_00_006e_VZ / ZL000_00_022e_WL / ZL000_00_023e_WL / ZL000_00_034e_WL

08.04.2019

Publication of time windows for submitting replies to the List of Questions for applications in the fast-track and temporary authorisation procedures

Dates of the meetings

20.02.2019

Adaptation of the Guidance document No marketing interruption of distribution HMV4

ZL203_00_002e_WL

18.02.2019

Adaptation of the Guidance document Renewal and discontinuation of authorisation on change of status (main authorisation/export licence) HMV4

ZL201_00_001e_WL

18.02.2019

Adaptation of the Guidance document Description of document protection HMV4

ZL000_00_024e_WL

05.02.2019

Modification of various documents relating to authorisation

ZL000_00_020e_WL / ZL100_00_002e_WL / ZL000_00_014e_WL / ZL300_00_003e_FO / ZL000_00_035e_FO

31.01.2019

Adaptation of the form Information for application Art.13 TPA HMV4

ZL101_00_004e_FO

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

Supplementary information

Allocation of IT groups to Case Management (XLS, 275 kB, 01.04.2019)

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