07/2022 - Industry Single Point of Contact (i-SPOC)
EU Regulation 2022/123 (dated 25/01/2022) determines the reinforced role for the European Medicines Agency (EMA) in crisis preparedness and management for medicinal products and medical devices.
Article 9 of this regulation requires that EMA 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.
In the event that an authorised medicinal product is included in a list of critical medicines identified for a specific public health emergency or major event, the list of i-SPOCs 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.
MAHs should identify their i-SPOC prior to 2 September 2022 (according to article 10 of EU Regulation 2022/123).
The IRIS platform of EMA will be used to collect details of i-SPOCs and to facilitate future communication with MAHs.
Registration of an i-SPOC is a two-step process.
- MAHs must first create an EMA account (IAM) - if they do not yet hold one (this can take 5-10 business days after the request is submitted) – see EMA Account Management (europa.eu)
- The user with a manager role in IAM creates a new submission for the registration of an i-SPOC in the IRIS portal. Registration of the i-SPOC within the IRIS portal is immediate.
A user guide and a video demo have been developed:
- iris-guide-applicants-how-create-submit-scientific-applications-industry-individual-applicants_en.pdf (europa.eu)
- i-SPOC Registration - YouTube
Are you ready?
Do not hesitate to contact us if you need further information or help with the registration of your i-SPOC! We are ready to assist you!