13/14 December 2023
Marketing Authorisation Holders (MAHs) can now register a central contact point, the so-called Industry Single Point of Contact (i-SPOC). This function is to inform the EMA about the supply and availability of critical medicines.
The background to this is the new Regulation (EU) 2022/123, which aims to strengthen the role of the EMA in crisis preparedness, including the monitoring and management of drug shortages. All pharmaceutical companies with a centrally or nationally authorised medicinal product in the EU are required to register a central contact point.
The i-SPOC is designed to facilitate rapid communication between EMA and regulatory authorities to identify, report and prevent or manage supply and availability problems for medicines on a list of critical medicines for a "public health emergency" or "major event". The Agency recently published the first list of critical medicines for dealing with the COVID-19 pandemic.
Companies must register their i-SPOC on the EMA's IRIS online platform by 2 September 2022.