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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 Guidance document Packaging for human medicinal products HMV4

ZL000_00_021e_WL

18.10.2019

Adaptation of the Forms Renewal of authorisation HMV4

ZL201_00_008e_FO / ZL201_00_010e_FO

27.09.2019

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

ZL108_00_002e_FO

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

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

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