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Information

01.12.2019

Modification of various documents relating to authorisation

ZL000_00_024e_WL / ZL101_00_007e_WL / ZL300_00_001e_WL

22.11.2019

Potential nitrosamine contamination: request to perform a risk evaluation

Marketing authorisation holders of human medicinal products asked to conduct their own evaluation of the potential risk of contamination with nitrosamines.

05.11.2019

Revised requirements regarding combination products

29.10.2019

Adaptation of the Directory Overview of documents to be submitted HMV4

ZL000_00_006e_VZ

29.10.2019

Adaptation of the Form Variations and extensions HMV4

ZL300_00_003e_FO

29.10.2019

Adaptation of the Guidance document Formal requirements HMV4

ZL000_00_020e_WL

22.10.2019

New templates: product information and patient information for human medicinal products – minimum requirements as per HMV4

ZL000_00_048d_VL / ZL000_00_049d_VL

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

Supplementary information

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

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