EDQM Draft guideline on ‘Content of the dossier for sterile substances’ released for public consultation (Catapult's regulatory round-up - May 2024)

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.

Publication Details

Journal
Industrias Culturais (Universidade de Coimbra)
Published
2024-11-04
DOI
https://doi.org/10.58079/12m73
Primary Topic
Agricultural safety and regulations
Type
article
Field-Weighted Citation Impact
0.00
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article

EDQM Draft guideline on ‘Content of the dossier for sterile substances’ released for public consultation (Catapult's regulatory round-up - May 2024)

Industrias Culturais (Universidade de Coimbra)
Agricultural safety and regulations
article

EDQM Draft guideline on ‘Content of the dossier for sterile substances’ released for public consultation (Catapult's regulatory round-up - May 2024)

article en

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.

Industrias Culturais (Universidade de Coimbra)
Openalex Percentile: Top 53%
Agricultural safety and regulations
DOIOpen Access PDFOpenAlex
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EDQM Draft guideline on ‘Content of the dossier for sterile substances’ released for public consultation (Catapult's regulatory round-up - May 2024) · Industrias Culturais (Universidade de Coimbra) (2024) | TGRS Research Map | TGRS