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

Title:
Guideline on quality documentation for medicinal products when used with a medical device

https://www.gmp-compliance.org/files/guidemgr/guideline-quality-documentation-medicinal-products-when-used-medical-device-first-version_en.pdf

Origin/Publisher:

EMA

Document Type:
Guideline
Content:
This guideline describes the information that should be presented in the Quality part of a marketing authorisation dossier for a medicinal product when it is used with a medical device, or device part

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