i-SPOC | New requirement for pharmaceutical companies

July 13, 2022

EMA has announced the obligation for Marketing authorisation holders of medicinal products authorised in the EU to appoint a so-called industry single point of contact (i-SPOC), in accordance with Regulation (EU) 2022/123, who can provide information directly to the EMA about the supply and availability of critical medicines identified in the context of a major event or public health emergency, such as the current COVID-19 pandemic.

All pharmaceutical companies with a centrally- or nationally-authorised medicinal product in the EU are required to register a single point of contact. All holders must register an i-SPOC by 2 September 2022 via the EMA’s IRIS platform. The IRIS guide for applicants has been updated to include information on the procedure to follow to register an i-SPOC, and there is also a demo available on the EMA website.

Monica Dias, Head of the Supply and Availability of Medicines and Devices, European Medicines Agency (EMA), also talked about this at the MFE annual event, held recently in Sitges, Barcelona.

Asphalion Managing Director, Núria Romero, listened first hand at her lecture, where Mrs. Dias stated that: “Concerted action at a European level to address medicine shortages is ongoing, like the established MSSG “Medicines shortages Steering Group”. She also said that the EMA is “Establishing a list of the main therapeutic group and critical medicines” and that “Single points of contact for MAHs will have to register in i-SPOC. Furthermore, the European Shortages Monitoring Platform (ESMP) is expected to go live on February 2, 2025”.

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In case you have any other requests, you can also send us an email at: info@asphalion.com

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