EMA takes further steps to address critical shortages of medicines in the EU
Today, EMA published details of the newly created solidarity mechanism developed by the EMA Medicines Shortages Steering Group (MSSG). This voluntary mechanism allows Member States to support each other in the face of a critical medicine shortage.
The solidarity mechanism, which is based on an informal setup during COVID-19, will enable any Member State facing a critical shortage that has been escalated to the MSSG for coordination at European level to request assistance from other Member States in obtaining medicine stocks. This mechanism can only be used under very limited conditions and was developed as a last resort for Member States after they have exhausted all other possibilities.
The solidarity mechanism complements a number of actions that the MSSG can carry out to address critical shortages in the EU. These were also published today as part of the MSSG Toolkit . The toolkit includes recommendations for monitoring supply and demand, an approach that was used to tackle the widespread critical shortages of antibiotics in the autumn and winter seasons of 2022 / 2023. The toolkit also provides guidance on interactions with marketing authorisation holders and manufacturers to increase and redistribute existing stocks and the implementation of regulatory flexibilities, such as 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.
The two documents published today are part of a clear set of actions announced by the European Commission today to protect Europe against medicines shortages in the future.
More about the MSSG
The MSSG was established under Regulation (EU) 2022/123, which reinforces the role of the Agency in crisis preparedness and management for medicines and medical devices in order to monitor shortages and ensure a robust response to major events or public health emergencies and to coordinate urgent actions on the supply of medicines within the EU. The Regulation formalises and strengthens the governance structures EMA had put in place to ensure swift and coordinated action during the COVID-19 pandemic.