Limitations to the use of ethylene oxide in the manufacture of medicinal products (human) - Scientific guideline

This document describes the circumstances where sterilisation with ethylene oxide can be applied.

Keywords: Ethylene oxide, sterilisation, carcinogenic

Document history

Revised note for guidance on limitations to the use of ethylene oxide in the manufacture of medicinal products - Superseded

Adopted Reference Number: EMEA/CVMP/271/01 Rev. 1 Summary:

This Rev.1 revision revises the coverpage (only) of the Note for guidance on limitations to the use of ethylene oxide in the manufacture of medicinal products (CPMP/QWP/159/01 & EMEA/CVMP/271/01 Rev.1). None of the text of the note for guidance (guideline) has been changed, only the cover page and the format.

Note for guidance on limitations to the use of ethylene oxide in the manufacture of medicinal products

Adopted Reference Number: CPMP/QWP/159/01 Legal effective date: 01/04/2001

Concept paper on a proposal to limit the applicability of the CPMP/CVMP Note for guidance on limitations to the use of ethylene oxide in the manufacture of medicinal products to veterinary medicinal products - Superseded

Adopted Reference Number: EMA/CHMP/SWP/211900/2015 Summary:

The proposed guideline will replace 'Note for Guidance on Limitations to the Use of Ethylene Oxide in the Manufacture of Medicinal Products’ (CPMP/QWP/159/01).