Request for early access authorization

Name: Request for early access authorization
Creator: National Agency for the Safety of Medicines and Health Products
Keywords: access,authorization,guidances,procedures,requests

Information

Original link

Type

Guidance

Regulated products

Medical Devices

Last updated

February 9, 2024

Description

Procedure Request for early access authorization

Organization

National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷

Country / Region

France

License

Other (Non-Commercial)

Feedback

Suggest an improvement to this page

11 Main files

Téléchargez l'infographie Process d’AAP pre-AMM (15/11/2021)

Updated on November 15, 2021

pdf

URL: https://ansm.sante.fr/uploads/2021/11/15/process-pre-amm-slide-28-juin.pdf
Permalink: https://data.openrid.co/en/datasets/r/9d593db2-f2ba-47e1-8144-0dcd42953dd7
MIME Type: application/pdf

Created on: November 15, 2021
Modified on: November 15, 2021

Téléchargez l'infographie Process d’AAP post-AMM (15/11/2021)

Updated on November 15, 2021

pdf

URL: https://ansm.sante.fr/uploads/2021/11/15/process-post-amm-slide-28-juin-v2.pdf
Permalink: https://data.openrid.co/en/datasets/r/f8de4aed-b3aa-4abf-b38f-3b909d4cc102
MIME Type: application/pdf

Created on: November 15, 2021
Modified on: November 15, 2021

Guide de dépôt - Version au 08/07/2021 (04/08/2021)

Updated on August 4, 2021

pdf

URL: https://ansm.sante.fr/uploads/2021/08/04/acces-precoces-guide-accompagnement-des-laboratoires-1.pdf
Permalink: https://data.openrid.co/en/datasets/r/1e107b15-e136-43e5-bcd1-1fc177645d70
MIME Type: application/pdf

Created on: August 4, 2021
Modified on: August 4, 2021

Modèle de dossier type (04/08/2021)

Updated on August 4, 2021

docx

URL: https://ansm.sante.fr/uploads/2021/08/04/acces-precoces-matrice-de-dossier-type.docx
Permalink: https://data.openrid.co/en/datasets/r/60bb067b-87b2-4495-80fd-99856027f7e3
MIME Type: application/vnd.openxmlformats-officedocument.wordprocessingml.document

Created on: August 4, 2021
Modified on: August 4, 2021

Modèle de protocole d'utilisation thérapeutique et de recueil de données (PUT-RD) (09/02/2024)

Updated on February 9, 2024

docx

URL: https://ansm.sante.fr/uploads/2024/02/09/modele-de-protocole-dutilisation-therapeutique-et-de-recueil-des-donnees-v2-1-22112023.docx
Permalink: https://data.openrid.co/en/datasets/r/cec54f11-9c1f-41e0-81cb-e892816dfc74
MIME Type: application/vnd.openxmlformats-officedocument.wordprocessingml.document

Created on: February 9, 2024
Modified on: February 9, 2024

Modèle de RCP, notice, étiquetage - Format pdf (27/09/2021)

Updated on September 27, 2021

pdf

URL: https://ansm.sante.fr/uploads/2021/09/27/20210927-apac-modele-rcp-notice-etiquetage-aap.pdf
Permalink: https://data.openrid.co/en/datasets/r/af4bb481-b22e-4159-ae19-d56d168e0bd3
MIME Type: application/pdf

Created on: September 27, 2021
Modified on: September 27, 2021

See the 11 main files