Marketing authorisation holders for all authorised medicines in the EU are required to appoint a so-called industry single point of contact (i-SPOC) who can provide information directly to EMA about the supply and availability of critical medicines identified in the context of a major event or a public health emergency, such as the current COVID-19 pandemic.
They need to register an i-SPOC by 2 September 2022.
EMA uses the i-SPOC contact list for rapid, two-way communication with the marketing authorisation holders of medicines included in a list of critical medicines by EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) during a public-health emergency or major event.
This aims to enable the European medicines regulatory network to detect, report, and prevent or manage issues related to the supply and availability of these medicines.
The list of critical medicines for COVID-19 is available.
The Agency is setting up the i-SPOC system in accordance with the Regulation on EMA’s Reinforced Role (Regulation (EU) 2022/123). It is based on the former enhanced monitoring system for medicines used in COVID-19 patients that EMA and pharmaceutical companies put in place in April 2020.