9 June 2022

EMA adopts first list of critical medicines for COVID-19

On 7 June 2022, EMA’s Medicines Shortages Steering Group (MSSG) adopted the list of PDF icon critical medicines for the COVID-19 public health emergency . The medicines included in the list are authorised for COVID-19 and their supply and demand will be closely monitored to identify and manage potential or actual shortages.

Marketing authorisation holders (MAHs) of medicines included in the list are required to regularly update EMA with relevant information, including data on potential or actual shortages and available stocks, forecasts of supply and demand. In addition, Member States will provide regular reports on estimated demand for critical medicines at national level. This will enable the MSSG to recommend and coordinate appropriate EU-level actions to the European Commission and EU Member States in order to prevent or mitigate potential or actual shortages of critical medicines to safeguard public health. EMA will liaise individually with the MAHs and national competent authorities to inform them of the timelines, processes and tools to collect the required information following the adoption of the list.

Given the current stage of the COVID-19 pandemic, the list of critical medicines includes all authorised COVID-19 vaccines (Table 1) and COVID-19 therapeutics (Table 2), and will be subject to update when necessary, to take into account any changes in COVID-19 epidemiology in EU/EEA which may give rise to an increased risk of shortages of particular medicines or following the authorisation of new medicines in the EU. The list will remain in place until the end of the public health emergency.

The list should not be read as providing guidance on the use of COVID-19 products in individual Member States and also does not reflect
recommendations for use to treat or prevent COVID-19 caused by any particular variant of the SARS-CoV-2 virus. Decisions on vaccination campaigns,
the choice of vaccine or treatment and how they are allocated are made at national level.

 All dexamethasone-containing medicines will be monitored, even though not all have currently an authorisation for COVID-19.

The list has also been shared with EU industry trade associations.