Drug Shortages: EMA asks Companies to register a Single Point of Contact

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

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.

Registering an i-SPOC is a two-step process that can take up to 5-10 working days. The EMA has also published an IRIS User Guide and a video to support companies in the registration process.

Companies must register their i-SPOC on the EMA's IRIS online platform by 2 September 2022.