EMA – Revision of the EMA post-authorisation procedural advice for users of the centralised procedure
Year: 2024
Type: other
Abstract: The EMA published its last version of the post-authorisation procedural advice for users of the centralised procedure. This guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures. It provides an overview of the Agency’s position on issues, which are typically addressed in discussions or meetings with MAHs in the post-authorisation phase. More information on post-authorisation on the EMA Website.
Source: OpenEdition (OpenEdition)
DOI: 10.58079/12j9o
Author: Vroby
Language: English
Topic: Healthcare Regulation
Subfield: Health Information Management
Field: Health Professions
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W6899018811
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