The FAMHP reminds marketing authorisation holders for medicinal products for human use to register a single point of contact (i-SPOC) for the supply and availability of medicinal products through the IRIS platform of the EMA.
Article 9 of Regulation (EU) 2022/123 requires the EMA to establish and maintain a list of single points of contact (i-SPOC) for authorisation holders. When a medicinal product appears on a list of critical medicinal products, this list will be crucial to enable swift two-way communication between the EMA or FAMHP and authorisation holders to detect, report and prevent or manage supply and availability issues.
i-SPOC registration has been mandatory since September 2, 2022, and applies to all pharmaceutical companies with a central or national authorised medicinal product in the EU. The requirement does not apply to parallel distributors.
Submission of i-SPOC data in the IRIS portal.
Registration of an i-SPOC involves two steps:
- If they do not already have it, marketing authorisation holders must first create an EMA account in the EMA Account Management platform (IAM) as this data will be used to log into the IRIS portal. Once this step is completed, the user with the administrator role in IAM can log into the IRIS portal and submit a new i-SPOC registration. Creating an EMA account can take 5-10 workdays after the application has been submitted.
- Registration of the i-SPOC in the IRIS portal is instantaneous.
A user guide and demo video have been developed to assist authorisation holders in this registration process. A presentation explaining key concepts and steps as well as a document answering frequently asked questions, are also available.
Technical support is also available through the EMA Service Desk.
The FAMHP takes this opportunity to thank all authorisation holders who have already registered their i-SPOC data.