Availability of medicines

This content applies to human and veterinary medicines.

Improving the availability of medicines authorised in the European Union (EU) is a key priority for the European Medicines Agency (EMA) and the European medicines regulatory network. Shortages or other problems with the availability of medicines create challenges for the medicine supply chain, with a potentially serious impact on human and animal health. 

Medicine shortages can occur for many reasons, such as manufacturing difficulties, problems affecting the quality of medicines or increased demand that can impact on patient care.

Regulatory authorities within and outside Europe are increasingly working together to prevent shortages and to limit their impact whenever they occur. The European medicines regulatory network aims to minimise the impact of medicine shortages on patients by:

• working with pharmaceutical companies to resolve manufacturing and distribution issues;
• sharing information with international partners about alternative sources of supply;
• seeking input from patients and healthcare professionals on the impact of medicine shortages, to support decision-making;
• taking measures to allow alternative medicines or suppliers to be used.

The HMA / EMA Task Force on the Availability of Authorised Medicines for Human and Veterinary Use is providing strategic and structural solutions to tackle disruptions in the supply of medicines and ensure their continued availability in the EU.

The Task Force focuses on the availability of authorised human and veterinary medicines, irrespective of the authorisation route. It does not cover non-authorised medicines. 

It is designed to function as a 'supply and availability hub', tracking progress on the medicine availability and shortage-related activities that the European medicines regulatory network is undertaking under the following EU projects:

• the European medicines agencies network strategy to 2025
• the European Commission's Pharmaceutical Strategy for Europe
• the 'Joint Action on Shortages', a three-year plan starting at the end of 2022 to enhance national systems in tackling medicines shortages in a harmonised way

This aims to streamline processes, ensure synergies and avoid duplication of work within the network.

In contrast, the structures and processes that EMA set up for dealing with medicine shortages in accordance with the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123) are primarily focusing on activities related to crisis situations. More information on these is available below under 'Crisis preparedness and management'.

The Task Force's priorities include:

• looking at ways to minimise supply disruptions and avoid shortages by facilitating approval and marketing of medicines using the existing regulatory framework (for example by work sharing and reduced timetables when possible);
• developing strategies to improve prevention and management of shortages caused by disruptions in the supply chain (for example developing guidance for companies on reporting of shortages);
• encouraging best practices to prevent shortages;
• improving sharing of information and best practices among EU regulatory authorities to better coordinate actions across the EU;
• fostering collaboration with stakeholders and enhancing communication of supply problems to EU citizens.

Structure, work programme and terms of reference

EMA and HMA agreed an updated structure for the Task Force in June 2022. They also agreed to extend its mandate for further three years.

They first set up the Task Force in December 2016, building on the network’s efforts since 2012 to improve processes for handling shortages caused by good manufacturing practice (GMP) non-compliance.

Its work was temporarily suspended between March 2020 and December 2021 due to the COVID-19 pandemic.

For more information, see:

• Heads of Medicines Agencies
• HMA/EMA Task Force on Availability of Authorised Medicines for Human and Veterinary Use
• Multi-stakeholder workshop with the HMA/EMA task force on availability of authorised medicines (09/11/2018)

Composition

The Task Force is composed of a steering committee and two thematic working groups.

Thematic working group 1 focuses on medicine availability and supply disruptions and thematic working group 2 focuses on communication.

The steering committee is co-chaired by a senior national competent authorities representative appointed by HMA, and a senior EMA staff member, as follows:

• Monica Dias - EMA's co-chair
• Hugues Malonne (Belgium's AFMPS) - HMA's co-chair

Its full list of members is available below:

EMA plays a key role in coordinating the EU response to medicine supply issues caused by crises such as major events or public health emergencies.

This includes monitoring medicine shortages that might lead to such a crisis situation, as well as reporting shortages of critical medicines during a crisis. 

For more information, see: 

• Crisis preparedness and management

Two bodies at EMA carry out these responsibilities:

• Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG)
• Medicine Shortages Single Point of Contact (SPOC) Working Party

EMA's response to shortages of antibiotics

A surge in respiratory infections across the EU in December 2022 and January 2023 led to an increased demand for antibiotics such as amoxicillin (alone and in combination with clavulanic acid), especially for use in children.

In response, the EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) engaged with supply-chain stakeholders to:

• monitor medicine shortages closely;
• provide regulatory support to companies so as to increase supplies; 
• encourage national competent authorities to use existing regulatory flexibilities such the exceptional supply of certain medicines that may not be authorised in a particular EU Member State, or full or partial exemptions to certain labelling and packaging requirements for medicines.

For the latest information on the MSSG's response to this shortage, see the 'news' section on the dedicated webpage:

• Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG)

List of main therapeutic groups

A list of main therapeutic groups (MTGs) is available to help EMA identify the critical medicines that will be needed in case of a specific public health emergency or major event.

This list includes medicines for use in emergency care, surgery and intensive care.

EMA reviews the MTG list every year and whenever necessary to take developments into account such as changes in clinical practice.

MSSG adopted the list in July 2022.

This followed consultations with theMedicine Shortages Single Point of Contact (SPOC) Working Party, EMA's Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP), and learned societies and industry associations.

Critical medicines for a specific public health emergency or major event, such as the current COVID-19 pandemic, are included on a separate list. Supply and demand for the medicines on this particular list are closely monitored so that potential shortages can be avoided or managed early.

EMA can coordinate swift actions across EU Members State to ensure the continued supply of medicines in case shortages do happen. 

Whereas Regulation (EU) 2022/123 imposes reporting requirements for marketing authorisation holders of critical medicines, it does not introduce reporting requirements related to the medicines on the MTG list.

For more information on how MSSG established the list of main therapeutic groups, see:

For more information, see:

• Availability of medicines during COVID-19 pandemic: Critical medicines for COVID-19

Marketing authorisation holders for all authorised 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, such as the current COVID-19 pandemic.

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 list of critical medicines for COVID-19 is available. 

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.

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 user guide on the IRIS platform.

Marketing authorisation holders who do not have an EMA account need to 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.

Since 2016, EMA publishes a public shortages catalogue assessed by its Committee for Medicinal Products for Human Use (CHMP) and / or the Pharmacovigilance Risk Assessment Committee (PRAC), providing clear information and recommendations, if relevant, to patients, healthcare professionals and other stakeholders. 

For more information:

• EMA shortages catalogue

Stakeholders can consult the list of national registers of shortages for human medicines from Member States of the EU and EEA:

• National registers of shortages

As of February 2023, stakeholders can also consult the national registers of shortages to find relevant information on veterinary medicines.

EMA's communications on shortages are in line with the HMA/EMA good practice guidance on communicating shortages to the public and the Agency's discussion paper on Communication by EMA on supply shortages of medicinal products

The European medicines regulatory network is closely monitoring the impact of the COVID-19 pandemic on the human and veterinary medicine supply chains in the EU.

For more information, see Availability of medicines during COVID-19 pandemic.

In July 2019, EMA and HMA published guidance for marketing authorisation holders on detecting and reporting medicine shortages:

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

The guidance is based on a harmonised definition of a shortage, as agreed by all national competent authorities and EMA. 

When a shortage occurs, or is expected to occur, in one or more EU Member State, 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.

EMA and HMA intend to launch a pilot project on implementing the guidance. This is on hold due to the COVID-19 pandemic. EMA and HMA will provide more information for marketing authorisation holders before the launch.

The guidance 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. 

From 25 March 2021, marketing authorisation applicants for orphan medicines and medicines to treat cancer will be invited to take part in a pilot project by declaring their market launch intentions on a voluntary and confidential basis.

The pilot aims to help regulators understand why delays may occur in the marketing of certain medicines in EU Member States after they receive a marketing authorisation.

EMA will invite marketing authorisation applicants to share this information via an online survey at the time of validation or when they receive the CHMP opinion. 

They will be also asked to provide feedback on challenges and limiting factors they face in ensuring the availability of their medicines in the EU.

The pilot project ran for 18 months, until August 2022.

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

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

Guidance is available on the measures that patients’ and healthcare professionals’ organisations can take to help prevent and manage shortages of human medicines in the EU.

These measures include:

• Setting up observatories for collecting and analysing information from patients and healthcare professionals on shortages and the early warning signs, together with the national competent authorities
• Defining criteria and ways for developing registries of essential and critical medicines, together with the national competent authorities
• Setting up campaigns across the EU to raise awareness of:
  • where to find information on ongoing medicine shortages;
  • the risks of stockpiling medicines;
  • safe use of medicines given as an alternative during a shortage.

The guidance draws on best practices and initiatives of individual EU Member States.

EMA developed the guidance in consultation with itsPatients' and Consumers' Working Party and theHealthcare Professionals' Working Party.

It published the guidance in July 2022. 

In July 2019, EMA and HMA published guidance for national competent authorities and EMA on good practices in communicating to the public on medicines' availability issues:

• Good practice guidance for communication to the public on medicines’ availability issues

It covers:

• who should communicate on a medicines shortage;
• who the target audience is;
• which format and communication tools to use;
• what information and when to publish;
• how to involve stakeholders in the preparation and dissemination of information;
• internal collaboration within the European medicines regulatory network;
• existing examples and initiatives that could be implemented in other Member States.

The guidance is based on a survey on how issues related to shortages and availability of medicines are measured and communicated to the public in EU Member States, which was carried out by the HMA / EMA Task Force on the Availability of Authorised Medicines for Human and Veterinary Use.

EMA has published a set of documents to support regulators involved in coordinating shortage situations due to good manufacturing practice (GMP) non-compliance:

• Criteria for classification of critical medicinal products
• Decision tree on escalation from national to European level
• Points to consider for the overall assessment of a supply shortage of a medicinal product due to GMP Non-compliance /quality defects
• Closing report on assessment of a supply shortage of a medicinal product due to manufacturing and quality problems
• Resources for issuing treatment recommendation during shortages of medicinal products
• Risk indicators for Shortages (Manufacturing and Quality)

The documents for regulators build on an EMA reflection paper on public health incidents that can arise due to manufacturing disruptions and an implementation plan to coordinate the assessment of shortages, develop risk-minimisation measures, alleviate the impact on patients and communicate within the European medicines regulatory network:

• Reflection paper on medicinal-product supply shortages caused by manufacturing / good-manufacturing-practice compliance problems
• Implementation plan 2012-2015

They also draw on input from an EMA workshop on product shortages due to manufacturing and quality problems in 2013 and a stakeholder meeting to review progress in 2015:

• Developing a proactive approach to the prevention of medicines shortages due to manufacturing and quality problems: Report from stakeholder meeting

For more information, see:

• Good manufacturing practice
• Quality defects and recalls

In the context of theBrexit: the United Kingdom's withdrawal from the European Union , EMA has published a questions-and-answers document to address potential questions from stakeholders on the supply of medicines in the EU after Brexit and what the Agency, the European Commission and national competent authorities in the Member States are doing to prevent potential medicine supply shortages due to Brexit: