ZL101_00_005e_WL Guidance document Authorisation of human medicinal product with new active substance

Name: ZL101_00_005e_WL Guidance document Authorisation of human medicinal product with new active substance
Creator: Swiss Agency for Therapeutic Products
Keywords: authorization,guidances,human-medicinal-products,medicinal-products

Information

Type

Guidance

Regulated products

Medical Devices

Published

September 1, 2024

Last updated

September 1, 2024

Description

Guidance document on authorizing human medicinal products with new active substances.

Organization

Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭

Country / Region

Switzerland

License

Other (Non-Commercial)

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4 Main files

ZL101_00_005d_WL Wegleitung Zulassung Humanarzneimittel mit neuer aktiver Substanz

Updated on September 1, 2024

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/de/dokumente/zulassung/zl_hmv_iv/zl101_00_005d_vwlnleitungfuerdiezulassungvonhumanarzneimittelnmi.pdf.download.pdf/zl101_00_005d_wlzulassungHumanneuerwirkstoff.pdf
Permalink: https://data.openrid.co/en/datasets/r/f017eae2-3b78-4b86-a843-6bd9e027cb63
MIME Type: application/pdf

Created on: September 1, 2024
Modified on: September 1, 2024

ZL101_00_005e_WL Guidance document Authorisation of human medicinal product with new active substance

Updated on September 1, 2024

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/zulassung/zl_hmv_iv/zl101_00_005d_vwlnleitungfuerdiezulassungvonhumanarzneimittelnmi.pdf.download.pdf/ZL101_00_005e_WL%20Guidance%20document%20Authorisation%20of%20human%20medicine%20with%20new%20active%20substance%20and%20major%20variatio.pdf
Permalink: https://data.openrid.co/en/datasets/r/2689cee3-e2a5-47f6-acef-58e32528a0ce
MIME Type: application/pdf

Created on: September 1, 2024
Modified on: September 1, 2024

ZL101_00_005i_WL Guida complementare Omologazione di medicamenti per uso umano con nuovo principio attivo

Updated on September 1, 2024

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/it/dokumente/zulassung/zl_hmv_iv/zl101_00_005d_vwlnleitungfuerdiezulassungvonhumanarzneimittelnmi.pdf.download.pdf/ZL101_00_005i_WL%20Guide%20compl%C3%A9mentaire%20Autorisation%20m%C3%A9d.%20humain%20nouveau%20principe%20actif%20modification%20essentielle.pdf
Permalink: https://data.openrid.co/en/datasets/r/31dcbcd8-61c9-4f76-aa8f-d633e845cf12
MIME Type: application/pdf

Created on: September 1, 2024
Modified on: September 1, 2024

ZL101_00_005f_WL Guide complémentaire Autorisation d’un médicament à usage humain contenant un nouveau principe actif

Updated on September 1, 2024

pdf

URL: https://www.swissmedic.ch/dam/swissmedic/fr/dokumente/zulassung/zl_hmv_iv/zl101_00_005d_vwlnleitungfuerdiezulassungvonhumanarzneimittelnmi.pdf.download.pdf/ZL101_00_005f_WL%20Guide%20compl%C3%A9mentaire%20Autorisation%20m%C3%A9d.%20humain%20nouveau%20principe%20actif%20modification%20essentielle.pdf
Permalink: https://data.openrid.co/en/datasets/r/8e7456bf-e3b5-4817-8660-dd1ef69d5f43
MIME Type: application/pdf

Created on: September 1, 2024
Modified on: September 1, 2024

ZL101_00_005e_WL Guidance document Authorisation of human medicinal product with new active substance

Information

Type

Regulated products

Published

Last updated

Description

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Country / Region

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