Medicine shortages and availability issues: guidance for regulators

Guidance is available from the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) to assist the national competent authorities in the European Union (EU) in effectively communicating to the public about issues related to the availability of human and veterinary medicines. Resources are also available to help them manage shortages caused by manufacturing or quality problems.

This content applies to human and veterinary medicines.

Communicating shortages to the public

Guidance is available to help the national competent authorities in the EU with communicate to the public about issues related to the availability of medicines.

It includes good practices in the following areas:

• 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 Heads of Medicines Agencies (HMA) / EMA Task Force on the Availability of Authorised Medicines for Human and Veterinary Use.

EMA and HMA published the guidance in 2019.

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

Reference Number: EMA/632473/2018

Managing shortages caused by manufacturing or quality issues

A set of documents is available to support regulators involved in coordinating shortage situations caused by good manufacturing practice (GMP) non-compliance.

Criteria for classification of critical medicinal products

Reference Number: EMA/314762/2013

Decision tree on escalation from national to European level

Reference Number: EMA/314722/2013

Points to consider for the overall assessment of a supply shortage of a medicinal product due to GMP Non-compliance /quality defects

Reference Number: EMA/352178/2013

Closing report on assessment of a supply shortage of a medicinal product due to manufacturing and quality problems.

Reference Number: EMA/443443/2013

Resources for issuing treatment recommendation during shortages of medicinal products

Reference Number: EMA/310484/2013

Risk indicators for Shortages (Manufacturing and Quality)

The documents build on:

• an EMA reflection paper on public health incidents that can arise due to manufacturing disruptions and corresponding 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;
• an EMA workshop on product shortages due to manufacturing and quality problems in 2013;
• a stakeholder meeting to review progress in 2015.

More information:

Reflection paper on medicinal-product supply shortages caused by manufacturing / good-manufacturing-practice compliance problems

Reference Number: EMA/590745/2012Summary:

This Reflection Paper is concerned with public health crises that arise due to unforeseen disruptions within the manufacturing process, caused by manufacturing/GMP compliance problems and affecting medicinal products for human use, independent of their route of authorisation, where a need for co-ordination of the assessment and risk reducing actions at a Community level has been identified.

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

Reference Number: EMA/708575/2012

Meeting report - Developing a proactive approach to the prevention of medicines shortages due to manufacturing and quality problems

Reference Number: EMA/679967/2015Summary:

Shortages of medicines have been a global problem for the past decade and have also increasingly affected the European Union (EU) with significant impact on patient care.

• Multi-stakeholder workshop with the HMA/EMA task force on availability of authorised medicines (09/11/2018)
• Good manufacturing practice
• Quality defects and recalls