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Request for Comments on a Draft Council of Europe Guidance Document on Traceability of Medicines in Hospital Settings


Dear Sir or Madam,


The European Directorate for the Quality of Medicines & HealthCare (EDQM) (Council of Europe) is seeking comments from interested parties on a draft guidance document on Traceability of Medicines in Hospital Settings.


Patient safety is a critical global concern in healthcare. Medication processes play a pivotal role in enhancing patient safety. In hospital settings, a key factor for safely managing medication processes is to establish full traceability of medicines (at primary packaging level for unit doses of a medicine) to minimise medication administration errors. While the goal is clear, practical complexities exist. Implementation of in-hospital medication traceability has only been achieved in some advanced European hospitals.


The scope of this work is to provide regulatory authorities and stakeholders with a guidance document on what our committees of experts consider the minimum requirements to be fulfilled for in-hospital full traceability of medicines until the point of administration to patients. Implementation of this guidance should contribute to ensuring the seven ‘rights’ of medication administration: right patient, right medicinal product (right indication or approved indication), right dose, right time, right administration route, right information and right documentation.


A joint working group was created to draft the Guidance document with experts from regulatory authorities, hospital pharmacies and non-governmental organisations nominated by two subordinate committees under the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH):

  • Committee of Experts on Quality and Safety Standards in Pharmaceutical Practices and Pharmaceutical Care CD-P-PH/PC (;
  • Committee of Experts on Minimising Public Health Risks Posed by Falsification of Medical Products and Similar Crimes CD-P-PH/CMED ( )


To facilitate the processing of responses from a wide range of interested parties, we can only accept comments at the level of national competent authorities, European or national association, organisation or body. The document can be shared with individual members to collect comments but, if this is the case, these must be assembled into one response to be sent from the authority, association, organisation or body to the EDQM.


Please read the draft Recommendation and then answer the questions that follow.


For any practical questions, please contact the EDQM secretariat at


The closing date of this survey and the public consultation is 10 May 2024. Please note that comments sent beyond this deadline will not be treated.


We appreciate your contribution and feedback to this consultation. 


Yours faithfully,


The EDQM Secretariat on behalf of the joint PC/CMED Working Group