The European Medicines Agency (EMA) is calling on marketing authorisation holders issued at central or national level to register their ‘Industry Single Point of Contact’ (i-SPOC) by 2 September.
Through their i-SPOC, pharmaceutical companies will inform the Agency of stock levels, possible tensions or shortages of their critical medicines in case of health emergencies or major events. Registration is a two-step process via the EMA’s secure IRIS platform.
As part of its strengthened mandate under Regulation (EU) 2022/123, the EMA was tasked with playing an active role in preventing and managing medicine shortages. It is in this context that the EMA has been tasked with coordinating the information collected through the i-SPOC network. In the event of a potential risk of shortage or shortage, the EMA will forward this information to the Executive Steering Group on Shortages and Safety of Medicinal Products (see EUROPE 12952/8).
Critical medicines in the event of a health emergency or major event will now be subject to a dynamic inventory. A first list of Covid-19 critical medicines identified by the Steering Group was published on Tuesday 7 June (see EUROPE 12968/31). (Original version in French by Émilie Vanderhulst)