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Information

18.10.2019

Adaptation of the Forms Renewal of authorisation HMV4

ZL201_00_008e_FO / ZL201_00_010e_FO

01.10.2019

Questions and answers about the revised therapeutic products legislation

30.09.2019

Fixed texts for medicinal products which are being reallocated from dispensing category C to B as of 2019

Adaptation of fixed texts for medicinal products that may continue to be dispensed by pharmacies without a medical prescription after expert advice.

27.09.2019

Adaptation of the form New authorisation for co-marketing of medicinal product HMV4

ZL108_00_002e_FO

23.09.2019

Adaptation of the Guidance document Fast-track authorisation procedure HMV4 and the Guidance document Temporary authorisation for human medicinal products HMV4

ZL104_00_002e_WL / ZL109_00_001e_WL

09.09.2019

Adaptation of the Guidance document Packaging for human medicinal products HMV4

ZL000_00_021e_WL

09.09.2019

Adaptation of the Form Renewal of authorisation HMV4

ZL201_00_007e_FO / ZL201_00_008e_FO / ZL201_00_010e_FO

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

Supplementary information

Allocation of IT groups to Case Management (XLS, 275 kB, 01.10.2019)

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