The European Directorate for the Quality of Medicines & HealthCare is seeking comments from interested parties on a draft guidance document on the topic of “Traceability of Medicines in Hospital Settings”.
The objective of this project is to provide regulatory authorities and stakeholders with a guidance document on the minimum requirements to be fulfilled for full in-hospital traceability of medicines, from their arrival on-site until their administration to patients.
Please read the draft Guidance Document and share your comments with the EDQM via this survey: Request for Comments on a Draft Council of Europe Guidance Document on Traceability of Medicines in Hospital Settings.
To facilitate the processing of responses from a wide range of interested parties, we can only accept comments submitted by national competent authorities and European or national associations, organisations or bodies. The document can nonetheless be shared with individual members of the aforementioned bodies but any comments received must be compiled into a single response to be sent by the authority, association, organisation or body to the EDQM.
The closing date for this survey and the public consultation is 3 May 2024. Please note that comments sent after this deadline will not be taken into consideration.
For any practical questions, please contact the EDQM Secretariat.
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