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01.04.2020

Changes to the guidance document Temporary authorisation of human medicinal products HMV4

ZL109_00_001e_WL

01.02.2020

Guidance document Authorisation according to Art. 14 para. 1 abis-quater TPA HMV4 updated

The new version of the guidance document enters into force on 1 February 2020.

01.01.2020

New guidance document on Medicinal Product Names HMV4

ZL000_00_043e_WL

01.12.2019

Modification of various documents relating to authorisation

ZL000_00_024e_WL / ZL101_00_007e_WL / ZL300_00_001e_WL

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

24.10.2019

Adaptation of the Guidance document Authorisation of herbal medicinal products HMV4

ZL101_00_008e_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

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