/Medicine shortages and availability issues: guidance for companies

NEWS

Medicine shortages and availability issues: guidance for companies

EMA

2026/08/07

Medicine shortages and availability issues: guidance for companies

This content applies to human and veterinary medicines.

The European Medicines Agency (EMA) provides guidance to marketing authorisation holders and other pharmaceutical industry actors on maintaining a continuous supply of their medicines on the European Union (EU) single market and minimising the impact of any medicine shortages.

For more information, see:

Medicine shortages and availability issues

Preventing medicine shortages

Guidance is available for marketing authorisation holders, wholesalers, distributorsand manufacturers to help ensure continuity in the supply of human medicines, prevent shortages or reduce their impact when they occur.

It includes the following recommendations:

Inform national competent authorities of potential or actual shortages as early as possible, and provide detailed information to predict impacts better and implement preventive measures.
Establish robust shortage prevention and management plans.
Optimise pharmaceutical quality systems and increase the resilience of complex, multinational supply chains.
Ensure timely communication between stakeholders in the supply chain.
Promote fair and equitable distribution to meet the needs of patients.

The HMA / EMA Task Force on the Availability of Authorised Medicines for Human and Veterinary Use developed the guidance in consultation with industry associations.

It complements the guidance for patients and healthcare professionals.

Good practices for industry for the prevention of human medicinal product shortages

Reference Number:

EMA/760980/2022

English (EN) (411.02 KB - PDF)

First published:

17/05/2023

View

Shortage prevention plans template and guidance

An updated version of the shortage prevention plan (SPP) template and guidance document is available for marketing authorisation holders (MAHs) below in this section.

MAHs are required to establish, maintain and keep these plans up to date for prescription medicines, as well as for other products identified by the European Commission under specified conditions.

MAHs should ensure they are ready to implement these plans before the legal deadline, expected from mid-2027.

The SPPs aim to:

Identify vulnerabilities in medicine supply chains
Ensure that appropriate measures are in place to prevent, mitigate or manage risks that could lead to shortages.

The updated SPP template and guidance is in line with the legal requirements of the new pharmaceutical legislation and incorporates feedback from the EU Medicines Regulatory Network. This includes the Medicine Shortages Single Point of Contact (SPOC) Working Party and MSSG, as well as industry associations.

EMA made available the initial SPP template in June 2024 and the corresponding guidance in December 2025. This was followed by a pilot phase aligned with the European Commission’s 2023 Communication to strengthen the security of medicine supply in the European Union.

Guidance for industry on implementing Shortage Prevention Plans (SPP)

English (EN) (1.33 MB - PDF)

First published:

07/08/2026

View

For more information, see:

Shortage mitigation plans template and guidance

Shortage mitigation plans (SMPs) support the management of actual or anticipated shortages by outlining measures that marketing authorisation holders (MAHs) take to reduce their impact on patients and healthcare systems.

The new pharmaceutical legislation requires MAHs to prepare SMPs for anticipated or actual shortages. EMA provides a template and guidance below to support MAHs in drafting these plans.

Revision of SMP template and guidance

EMA is currently revising these documents to:

Reflect experience gained through the pilot
Improve usability of the documents
Align the documents with the requirements set out in the new pharmaceutical legislation

The revision process will include engagement with EMA's SPOC Working Party and relevant stakeholders.

Adoption is planned for the fourth quarter of 2026.

Medicine shortage mitigation plan - template

Reference Number:

EMA/549303/2023

English (EN) (285.52 KB - PDF)

First published:

18/06/2024

Last updated:

04/12/2024

View

Guidance for industry on implementing shortage mitigation plans (SMP)

Reference Number:

EMA/183138/2024

English (EN) (312.37 KB - PDF)

First published:

09/12/2024

View

Pilot to implement shortage prevention and mitigation plans

EMA conducted a pilot between December 2024 and September 2025 to assess the implementation of shortage prevention and mitigation plans and to identify opportunities and challenges associated with their use.

The pilot aimed to:

enable cooperation between MAHs and competent authorities for the harmonised implementation of shortage prevention and mitigation plans;
gather practical experience on the use of the templates provided by EMA; and
identify implementation challenges and opportunities for improvement.

As part of the pilot, EMA requested selected MAHs to prepare SPPs for specific medicinal products marketed in the European Union (EU)/European Economic Area (EEA).

MAHs were requested to submit SMPs for shortages that occurred during the pilot period.

The pilot focused on medicinal products, selected from the Union list of critical medicines. The products contained the following active substances:

alteplase;
amoxicillin;
amoxicillin/clavulanic acid; and
verteporfin.

EMA's SPOC Working Party requested the inclusion of additional medicinal products in response to ongoing critical shortages, while MAHs voluntarily submitted additional medicinal products for inclusion. These included products containing:

trabectedin;
etoposide;
fludarabine;
vincristine; and
peginterferon alfa-2a

The MSSG adopted the report summarising the pilot findings in December 2025. The lessons learned from the pilot informed the revision of the SPP and SMP templates and accompanying guidance.

Shortage Prevention Plan (SPP) and Shortage Mitigation Plan (SMP) pilot report

English (EN) (348.62 KB - PDF)

First published:

17/12/2025

View

For more information, see:

Detecting and reporting medicine shortages

Guidance is available for marketing authorisation holders for human and veterinary medicines on detecting and reporting medicine shortages, based on a harmonised definition of a shortage agreed upon by all national competent authorities and EMA.

When a shortage occurs, or is expected to occur, in one or more EU Member States, the marketing authorisation holder should report it to the national competent authorities concerned. If the shortage concerns a centrally authorised product, the marketing authorisation holder should also notify EMA.

The guidance contains a reporting template for use if none is provided by the country in question.

It aims to facilitate the early notification of shortages to national competent authorities, allowing them sufficient time to make contingency arrangements where necessary. It covers:

what constitutes a shortage;
what issues marketing authorisation holders should report;
who is responsible for monitoring supply and reporting shortages;
when and whom to notify;
what information to include in notifications.

It does not cover issues such as withdrawals of marketing authorisations, which can also affect a medicine's availability.

Guidance on detection and notification of shortages of medicinal products for Marketing Authorisation Holders (MAHs) in the Union (EEA)

Reference Number:

EMA/674304/2018

English (EN) (320.45 KB - PDF)

First published:

04/07/2019

View

EMA and HMA published the guidance in July 2019.

Medicine shortage communication

A medicine shortage communication (MSC) template is available for marketing authorisation holders to inform healthcare professionals of a medicine shortage.

MSCs are published for shortages linked to withdrawal for commercial decisions and unexpected demand increase for certain medicines.

They are used instead of direct healthcare professional communications (DHPCs) when shortages are not linked to quality, safety or efficacy issues.

Find the template, as well as more information on this topic, on the webpage linked below:

Industry contact points for supply and availability of critical medicines

Marketing authorisation holders for all authorised human medicines in the EU are required to appoint a so-called industry single point of contact (i-SPOC) who can provide information directly to EMA about the supply and availability of critical medicines identified in the context of a major event or a public health emergency.

They needed to register an i-SPOC by 2 September 2022.

EMA uses the i-SPOC contact list for rapid, two-way communication with the marketing authorisation holders of medicines included in a list of critical medicines by EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) during a public-health emergency or major event.

This aims to enable the European medicines regulatory network to detect, report, and prevent or manage issues related to the supply and availability of these medicines.

The Agency is setting up the i-SPOC system in accordance with the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123). It is based on the former enhanced monitoring system for medicines used in COVID-19 patients that EMA and pharmaceutical companies put in place in April 2020.

For more information, see:

Registering an i-SPOC

Marketing authorisation holders need to identify their i-SPOC via EMA's IRIS platform.

They can log in to IRIS using their EMA account credentials.

Guidance on how to register an i-SPOC is available in the demo video below, and in the IRIS guide for applicants - How to create, submit and manage IRIS applications, for industry and individual applicants.

Marketing authorisation holders without an EMA account must create one first via EMA's Account Management portal. This could take 5-10 working days.

For technical support, they should contact the EMA Service Desk.

Voluntary sharing of market launch intentions (pilot project)

Between March 2021 and August 2022, marketing authorisation applicants for orphan medicines and medicines to treat cancer were invited to participate in a pilot project by declaring their market launch intentions on a voluntary and confidential basis.

This aimed to help regulators understand why delays may occur in marketing of certain medicines in EU Member States after receiving a marketing authorisation.

EMA invited marketing authorisation applicants to share this information via an online survey during validation or when they received the CHMP opinion. They were also asked to provide feedback on challenges and limiting factors they face in ensuring the availability of their medicines in the EU.

The European Commission, EMA and the national competent authorities ran this pilot in the context of the Pharmaceutical strategy for Europe.

More information is available on the European Commission's website and in the question-and-answer (Q&A) document below.

Pilot project ‘Market Launch Intentions of Centrally Authorised Products’ - practical questions and answers

Reference Number:

EMA/90075/2021

English (EN) (108.99 KB - PDF)

First published:

05/03/2021

View

Page update history

An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.

The tracking of updates begins in August 2026.

See update history

6 August 2026

Shortages prevention plan guidance and template updated and published in one single document
Information on shortages prevention plans, shortages mitigation plans and the respective pilot to implement them revised

Summary

Guidance to pharmaceutical industry actors on maintaining a continuous supply of their medicines in the European Union (EU).