Quality documentation for medicinal products when used with a medical device - Scientific guideline

Name: Quality documentation for medicinal products when used with a medical device - Scientific guideline
Creator: European Medicines Agency
Keywords: draft,drug-device,guidelines,medical-devices,medicinal-products,overview,quality,requirements,scientific

Information

Original link

Type

Miscellaneous

Regulated products

Medical Devices

Last updated

December 8, 2021

Description

Guideline for quality documentation of medicinal products used with medical devices.

Organization

European Medicines Agency (EMA) 🇪🇺

Country / Region

European Union

License

Other (Public Domain)

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3 Main files

Guideline on quality documentation for medicinal products when used with a medical device - First version

Updated on July 23, 2021

pdf

URL: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-quality-documentation-medicinal-products-when-used-medical-device-first-version_en.pdf
Permalink: https://data.openrid.co/en/datasets/r/842f107a-0c71-4960-9bfe-03cb362aea5c
MIME Type: application/pdf

Created on: July 23, 2021
Modified on: July 23, 2021

EMA/CHMP/QWP/BWP/259165/2019

Overview of comments received on 'Draft guideline on the quality requirements for drug-device combinations - First version'

Updated on December 8, 2021

pdf

URL: https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-guideline-quality-requirements-drug-device-combinations-first-version_en.pdf
Permalink: https://data.openrid.co/en/datasets/r/d3d36338-27fc-42c6-8f9a-a5486d19e083
MIME Type: application/pdf

Created on: December 8, 2021
Modified on: December 8, 2021

EMA/CHMP/QWP/BWP/725078/2021

Draft guideline on the quality requirements for drug-device combinations - First version

Updated on June 3, 2019

pdf

URL: https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-quality-requirements-drug-device-combinations-first-version_en.pdf
Permalink: https://data.openrid.co/en/datasets/r/e69bad5d-9daa-47c6-8a96-f40d608b6546
MIME Type: application/pdf

Created on: June 3, 2019
Modified on: June 3, 2019