EMA – Update of the EMA’s guidance documents on pre-authorisation and post-authorisation procedural advice for users of the centralised procedure

Those two guidance documents in the form of Q&As address a number of questions which users of the centralised procedure may have regarding the pre-authorisation and post-authorisation procedures: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (web version of the Q&A) European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (web versions of the Q&As) Find more guidance on Marketing authorisation...

Publication Details

Journal
Industrias Culturais (Universidade de Coimbra)
Published
2025-05-16
DOI
https://doi.org/10.58079/13xye
Primary Topic
Pharmaceutical Quality and Counterfeiting
Type
article
Field-Weighted Citation Impact
0.00
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article

EMA – Update of the EMA’s guidance documents on pre-authorisation and post-authorisation procedural advice for users of the centralised procedure

Industrias Culturais (Universidade de Coimbra)
Pharmaceutical Quality and Counterfeiting
article

EMA – Update of the EMA’s guidance documents on pre-authorisation and post-authorisation procedural advice for users of the centralised procedure

article en

Abstract

Those two guidance documents in the form of Q&As address a number of questions which users of the centralised procedure may have regarding the pre-authorisation and post-authorisation procedures: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (web version of the Q&A) European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (web versions of the Q&As) Find more guidance on Marketing authorisation...

Industrias Culturais (Universidade de Coimbra)
Openalex Percentile: Top 44%
Pharmaceutical Quality and Counterfeiting
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EMA – Update of the EMA’s guidance documents on pre-authorisation and post-authorisation procedural advice for users of the centralised procedure · Industrias Culturais (Universidade de Coimbra) (2025) | TGRS Research Map | TGRS