European Medicines Agency (EMA) requires the Marketing Authorisation Holders (MAHs) to register an Industry Single Point of Contact (i-SPOC). This is to inform the 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 article 9 requires that the Agency establish and maintain a list of Industry Single Points of Contact (i-SPOC) of Marketing Authorisation Holders for all medicinal products authorised in the Union. This aims to strengthen EMA’s role in crisis preparedness including the monitoring and management of drug shortages that may lead to crisis.
The i-SPOC is built for faster communication between EMA and MAH with the reporting of shortages, information on supply and demand during a public health emergency or a major event. EU countries will have coordinated responses to shortages of critical medicines.
All pharmaceutical companies with a centrally or nationally authorized medicinal product in the EU are called to register a single point of contact.
If an authorized product is identified as a critical medicine for a specific public health emergency or major event, the list of contacts will be used to enable faster two-way communication between EMA and the MAHs with identified critical medicines to monitor, report, and prevent or manage supply and availability issues.
The details of i-SPOCs will be collected using the EMA’s IRIS platform, which will also be the communication tool to those MAHs of identified critical medicines during public health emergencies or major events.
Companies will need to submit their i-SPOC to the platform. The registration is a two-step process. An EMA account (IAM) is required. MAHs without IAM will need to create an account as these credentials are used to sign in to the IRIS portal. The user with manager role in IAM may log in to the portal and create a new submission in registering of an i-SPOC. Account creation in EMA may take 5-10 business days after the request is submitted. On the other hand, an i-SPOC registration within the IRIS portal is immediate.
A user guide and a video demo are available to help MAHs in the registration process. The user guide can be found on the IRIS guide for applicants, and the video demo is available here. Technical support is also available through EMA’s service desk.
Companies must register by the 2nd of September 2022.