Marketing authorisation holders (MAHs) can now 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’ .

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’. The Agency recently published the first list of critical medicines for the management of the COVID-19 pandemic.

Registration of an i-SPOC is a two-step process which may take up to 5-10 working days. EMA has updated the IRIS user guide  and published a video demo to support companies with the registration process.

Companies must register their i-SPOC in EMA’s IRIS online platform by 2 September 2022.

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