Medicine shortages and availability issues: guidance for companies
Guidance to pharmaceutical industry actors on maintaining a continuous supply of their medicines in the European Union (EU).
HumanVeterinaryMedicine shortages
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Updated on 17 December 2022:
'Shortage prevention and mitigation plans' section - to publish a pilot report on the implementation of these plans
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:
Preventing medicine shortages
Guidance is available for marketing authorisation holders, wholesalers, distributors and 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.
Shortage prevention and mitigation plans
Templates and guidance
EMA encourages marketing authorisation holders (MAHs) in the EU / European Economic Area (EEA) to prepare plans to prevent and mitigate shortages.
These plans will help ensure continued and secure availability of medicines.
MAHs should set up shortage prevention plans (SPPs) for the medicines they market. This will identify potential risks in the supply chain as well as measures to manage those risks.
MAHs should also prepare shortage mitigation plans (SMPs) to help minimise the impact of potential or actual shortages on patients and health systems.
Templates and guidance documents are available for MAHs to draft their shortage prevention and mitigation plans.
These templates align with the good practices for industry for the prevention of human medicinal product shortages, published under the 'Preventing medicine shortages' section on this page.
EMA made guidance available in December 2024, in preparation for the new pharmaceutical legislation. This was in line with the Commission's October 2023 communication on addressing medicine shortages in the EU.
For more information, see:
- Preventing medicine shortages
- EMA welcomes political agreement on new EU pharmaceutical legislation (11/12/2025)
- Reform of the EU pharmaceutical legislation: Affordable, accessible, and innovative medicines
- European Commission: Stepping up action to prevent shortages of medicines in Europe (24/10/2023)
Pilot to implement shortage prevention and mitigation plans
A report is available on EMA's pilot to identify the opportunities and challenges of implementing shortage prevention and mitigation plans.
The pilot aimed to:
- enable MAHs and competent authorities to cooperate for the harmonised implementation of shortage prevention and mitigation plans;
- collect information on how MAHs use the templates that EMA provided, and identify any challenges and opportunities.
In this pilot, EMA asked certain MAHs to prepare shortage prevention plans for specific medicines that they place on the EU / EEA market.
In cases where shortages occurred for these medicines during the pilot, EMA also asked MAHs to submit shortage mitigation plans.
The pilot focused on medicines containing the following active ingredients:
• Alteplase
• Amoxicillin
• Amoxicillin with clavulanic acid
• Verteporfin
These active ingredients feature in the Union list of critical medicines.
The pilot included additional medicines at the request of EMA's Medicine Shortages Single Point of Contact (SPOC) Working Party. This happened due to ongoing critical shortages or via voluntary submissions from MAHs. The list of additional medicines included: trabectedin, etoposide, fludarabine, vincristine, and peginterferon alfa-2a.
The MSSG adopted the report summarising the pilot's findings in December 2025.
The pilot ran between December 2024 and September 2025.
The pilot's conclusions inform updates to the related templates and guidance documents.
EMA continues to work with MAHs to ensure preparedness for the submission of these plans in anticipation of the new pharmaceutical legislation.
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.
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:
- Crisis preparedness and management
- Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG)
- Availability of medicines during COVID-19
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.