Today, 2nd September 2022, is the last day for MAHs in Europe to fulfill their responsibility in accordance to Article 9 and 10 of REGULATION (EU) 2022/123 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL as of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices. Meaning that companies must register their Industry Single Point of Contact (i-SPOC) on supply and availability.
If an authorised product is on a list of critical medicines identified for a specific public health emergency or major event, the i-SPOC list of contacts will be used to enable rapid, two-way communication between EMA and the MAHs of those identified critical medicines to detect, report, and prevent or manage supply and availability issues.
The IRIS platform will be used to gather details of i-SPOCs for all MAHs and for future communication with those MAHs of identified critical medicines in case of public health emergencies or major events. Registration should be performed in IRIS for MAHs to identify their i-SPOC.
Registration of an i-SPOC is a two-step process. MAHs first create an EMA account (IAM), as these credentials are used to log in to the IRIS portal. Second step is: the user with manager role in IAM log into the IRIS portal and create a new submission for the registration of an i-SPOC. Creation of an EMA account may take 5-10 business days after the request is submitted. Registration of the i-SPOC within the IRIS portal is immediate.
To support MAHs in registration process following is available: a user guide, a video demo and technical support through EMA’s service desk – see useful links: