As laid down in Regulation (EU) 2022/123, the European Medicines Agency (EMA) has a primary role in monitoring and mitigating potential and actual shortages of medicinal products for human use considered critical to address a given ‘public health emergency’ or ‘major event.
In light of this, EMA has announced the obligation for Marketing Authorisation Holders (MAHs) of medicinal products authorised in the EU to appoint a so-called Industry Single Point of Contact (i-SPOC).
The i-SPOC has been introduced to enable the rapid communication between EMA and the Marketing Authorization Holders to detect, report, and prevent or manage supply and availability issues of medicines included in a list of critical medicines for a ‘public health emergency’ or a ‘major event’.
All pharmaceutical companies with a centrally or nationally-authorized medicinal product in the EU are required to register their i-SPOC by 2 September 2022 via the EMA’s IRIS platform.
RPN is available for any regulatory need including the support for the registration of their Industry Single Point of Contact in the EMA IRIS platform.