Back European Drug Shortages Formulary (EDSForm) takes shape: EDQM publishes first EDSForm texts for public consultation

EDQM Strasbourg, France 01/10/2025
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European Drug Shortages Formulary (EDSForm) takes shape: EDQM publishes first EDSForm texts for public consultation

The European Directorate for the Quality of Medicines & HealthCare (EDQM) is extremely pleased to announce the public consultation on the first three texts of its second formulary after the European Paediatric Formulary (launched in 2019). Healthcare professionals and interested parties across Europe are invited to provide feedback on the draft Amoxicillin capsules monograph and on the Introduction to the European Drug Shortages Formulary and the General principles of the European Drug Shortages Formulary, two general texts intended to help users navigate the content and concepts laid down in the Formulary.

The EDSForm Working Party – comprising experts from 12 European countries – worked diligently to finalise these first texts within a few months after their addition to its work programme in November 2024.

The EDSForm brings together, at European level, monographs describing methods for the preparation and quality control of unlicensed pharmaceutical preparations that may be needed when licensed alternatives are unavailable. The monographs are made freely accessible via the newly launched Pharmeuropa EDSForm platform.

Run under the joint auspices of the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH) and the European Pharmacopoeia Commission, the overarching aim of the project is to give pharmacists and clinicians access to harmonised formulations that can be prepared safely and effectively in the event of a shortage.

Monographs selected for inclusion in the EDSForm are subject to rigorous evaluation based on criteria adopted by the CD-P-PH, including the reproducibility of the preparation process, therapeutic relevance and compliance with European Pharmacopoeia requirements.

All interested parties are strongly encouraged to visit Pharmeuropa EDSForm to access the texts and contribute to the consultation. EDSForm texts are freely available after registration and comments can be made directly in the platform, with a commenting deadline of 31 December 2025.

It is anticipated that the finalised texts will be published by mid-2026 on the same platform. Further information on the EDSForm, the work of the EDSForm Working Party and the EDQM’s concerted response to drug shortages can be found here: EDQM initiatives on medicine shortages.