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Information

20.08.2019

SwissPAR HMV4 guidance document modified

ZL000_00_030e_WL

14.08.2019

Adaptation of the form Variations and extensions HMV4

ZL300_00_003e_FO

09.08.2019

Modification of various documents relating to authorisation

ZL000_00_006e_VZ / ZL000_00_022e_WL / ZL105_00_004e_FO

01.08.2019

Adaptation of the Guidance document Fast track authorisation procedure HMV4

ZL104_00_002e_WL

01.08.2019

Adaptation of the Guidance document Procedure with prior notification HMV4

ZL101_00_013e_WL

15.07.2019

Questions and answers on variations and extensions HMV4

Revision

15.07.2019

Medicinal products with orphan drug status

Eligibility for procedure with prior notification and modification of billing practice for fast-track authorisation procedure

12.07.2019

Information on GCP inspections

09.07.2019

Adaptation of the Guidance document Formal requirements HMV4

ZL000_00_020d_WL

08.07.2019

Renewal of authorisation for medicinal products whose authorisation expired as of 1 January 2020

19.06.2019

New templates for manuscripts of Information for healthcare professionals and Patient information

mandatory from 1 July 2019

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

Supplementary information

Allocation of IT groups to Case Management (XLS, 275 kB, 01.08.2019)

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