All Marketing authorisation holders (MAHs) should register their Industry Single Point of Contact (i-SPOC) who will inform EMA about the supply and availability of critical medicines identified in the context of a ‘public health emergency’ or a ‘major event’ (such as the current COVID-19 pandemic). This applies for all authorised medicines in the EU (including nationally registered products).
Regulation (EU) 2022/123 reinforces EMA’s role in crisis preparedness, including the monitoring and management of medicine shortages that may lead to a crisis and, during a public health emergency or a major event, with the reporting of shortages, information on supply and demand, and coordinating responses of EU countries to shortages of critical medicines. All pharmaceutical companies with a centrally- or nationally-authorised medicinal product in the EU are required to register a single point of contact.
The i-SPOC will facilitate rapid communication between EMA and MAHs to detect, report, and prevent or manage supply and availability issues of medicines included in a list of critical medicines for a ‘public health emergency’ or a ‘major event’.
Companies must register their i-SPOC in EMA’s IRIS online platform by 2 September 2022.