Registration of an "Industry Single Point of Contact (i-SPOC)" for supply and availability at EMA
Regulation (EU) 2022/123 reinforces EMA’s role in crisis preparedness and the management of medicinal products. The Regulation sets out a framework for the monitoring and management of medicinal shortages during public health emergencies and major events. As part of this framework, pharmaceutical industry and Member States will be required to provide information at both the medicinal product, as well as the supply and demand level.
Under the new Regulation, Marketing Authorisation Holders (MAH) must now register an Industry Single Point of Contact (i-SPOC) for all human medicinal products authorised in the Union (centrally- or nationally authorised medicinal products). The i-SPOC will facilitate rapid communication between EMA and MAHs 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".
There is no need for parallel distributors to register an i-SPOC on supply and availability.