EDQM Draft guideline on ‘Content of the dossier for sterile substances’ released for public consultation (Catapult's regulatory round-up - May 2024)
Year: 2024
Type: other
Abstract: EDQM has drafted a guideline ‘Content of the dossier for sterile substances’ (PA/PH/CEP (23) 54) which is now available for public consultation until 15 August 2024. It is intended for applicants as a guide for compiling a dossier in order to obtain a Certificate of Suitability (CEP) for a sterile substance. This guidance document can be downloaded here. Published on the 5th of June in Catapult's regulatory round-up for May 2024.
Source: OpenEdition (OpenEdition)
DOI: 10.58079/12m73
Author: Adelage
Language: English
Topic: Healthcare Regulation
Subfield: Health Information Management
Field: Health Professions
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W6936765505
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