EMA updates Guideline on implementing the Shortage Prevention Plan

On 7 August 2026, the European Medicines Agency (EMA) published an updated guidance on implementig the Shortage Prevention Plan (SPP). The document is aimed in particular at Marketing Authorisation Holders (MAHs) and is intended to help them assess the security of supply of medicines more systematically and prevent potential supply shortages at an early stage.

Shortage Prevention Plans are a key tool in the European approach to safeguarding the supply of medicines. They are not intended to come into play only once a shortage has already occurred. Rather, the aim is to proactively identify potential vulnerabilities along the supply chain, assess their significance and define appropriate precautionary measures. Factors such as dependence on individual production sites or suppliers, limited production capacities, the availability of critical raw materials, logistical risks or a lack of alternative options may play a role here.

Under current and future European requirements, marketing authorisation holders (MAHs) must draw up appropriate plans for prescription-only medicines, maintain them on an ongoing basis and update them in the event of changes to the regulatory framework. In addition, other medicines may also be included, provided that the European Commission deems them relevant under specified conditions. Companies are therefore expected not only to document their supply chain risks on a one-off basis, but also to integrate the plans as a living system into their existing processes for risk analysis, supply chain monitoring and crisis management.

The updated EMA template takes into account the requirements of the new European pharmaceutical legislation whilst also incorporating feedback from the EU Medicines Regulatory Network. The revision incorporates, amongst other things, experiences and guidance from the Medicine Shortages Single Point of Contact (SPOC) Working Party and the Medicine Shortages Steering Group (MSSG), as well as contributions from industry associations. This is intended to harmonise the application of the SPPs more closely and improve the comparability of the underlying assessments.

For the pharmaceutical industry, the expected timetable is of particular importance. The statutory implementation deadline is currently expected to be from mid-2027. Marketing authorisation holders (MAHs) should therefore not wait until the specific obligations come into force, but should assess at an early stage which medicinal products fall within the scope of application, which internal responsibilities need to be defined, and whether the necessary data and assessment criteria are available. It is also advisable to review existing measures for preventing shortages to ensure they cover the level of detail and structure expected in the updated template.

This publication is linked to the EMA’s previous work on establishing a harmonised framework for the prevention of shortages. An initial SPP template had already been made available in June 2024, with the accompanying guidance following in December 2025. A pilot phase was subsequently carried out. This work forms part of European efforts to strengthen security of supply and enhance the resilience of the medicines supply chain in the face of complex, international supply chains.

With the updated template, MAHs now have an important basis for their further preparations. Companies should incorporate the document “Guidance for industry on implementing Shortage Prevention Plans (SPP)” into their gap analysis and, in particular, assess whether risks have been prioritised in a transparent manner, whether prevention and mitigation measures have been described in sufficient detail, and whether monitoring, escalation and updating processes are clearly defined.