This paper focuses on proactive mechanisms to prevent shortages of medicines for human use. As patients and healthcare professionals are the main actors at the end of the supply chain, their activities in preventing shortages are usually limited to demand management strategies.

This paper goes beyond standard demand management strategies and also looks at measures that help to improve preparedness, planning and rationed use for medicines that are either in short supply or expected to be so in the near future. Such actions may not prevent a shortage at hand but may help to manage the impact of future shortages. Measures include improved communication and information flow, as well as measures to better handle the use of alternative medicines.


This guidance refers to medicines for human use only. Shortages referred to in this guidance are to be understood in the context of the harmonised definition agreed by EMA-HMA in the “Guidance on detection and notification of shortages of medicinal products for Marketing Authorisation Holders (MAHs) in the Union (EEA)”: ‘A shortage of a medicinal product for human or veterinary use occurs when supply does not meet demand at a national level’. The definition applies to all shortages that are
already affecting or that are expected to affect one or more EU member states in the future. It applies to both prescription and non-prescription medicines


Availability issues are wider than shortages and concern supply issues linked to revocations or cessations of marketing authorisations. 
Most shortages and availability issues are managed at national level; some are managed at EU level.
Processes for prevention of shortages and availability issues vary among member states and this document intends to review and consolidate existing practices into a single document, providing clear and harmonised guidance to stakeholders, promoting good practices and improving EU coordination.


Purpose of the document

This document provides patients and healthcare professionals with key principles and examples of good practices (included as an annex) for shortage prevention and management. It is intended for guidance only. Implementation needs to consider national healthcare settings and regulatory frameworks in place at national level.
This document has been developed in the context of the HMA/EMA Task Force on the Availability of Authorised Medicines for Human and Veterinary Use, which was set up in December 2016 to provide strategic support and advice to tackle disruptions in supply of human and veterinary medicines and to ensure their continued availability. The document does not address commercial activities such as pricing of medicines because this is outside the remit of the Task Force.
The recommendations given in this document have been developed following a review of current practices across the EU, in consultation with representatives of healthcare professionals’ and patients’ organisations, taking into account other published frameworks for the management and prevention of medicine shortages. These practices are presented in more detail in the annex (section 2).

The document aims to promote good practice by:
• Enhancing and exploring current practices for prevention;
• Increasing visibility and accessibility of information on existing practices for prevention;
• Fostering interaction and improving information exchange between the different stakeholders.