The Management Board was updated on the ongoing efforts of EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) to closely monitor several critical shortages of medicines in the EU/EEA, in particular medicines containing the antibiotic amoxicillin.

Since the last Board meeting, the MSSG has been encouraging EU Member States to consider national regulatory flexibilities to allow the distribution of medicines that may not be authorised in their Member States. In addition, EU regulators have met with the main parties involved in the supply chain of amoxicillin to provide regulatory support to increase production capacity.

At their latest meeting on 15 March, the MSSG discussed plans to mitigate shortages of antibiotics for the next autumn/winter season. EMA, in cooperation with the European Commission’s Health Emergencies and Preparedness Response Authority (DG HERA), will liaise with key manufacturers to discuss manufacturing capacity and forecasts…