The continued availability of medicines is one of the most important priorities for EU authorities. Indeed, shortages or other problems with the availability of medicinal products create challenges for the medicine supply chain and represent a growing threat to public health.
To prevent or manage issues related to the supply and availability of medicines included in a list of critical medicines identified in the context of a “public health emergency” or a “major event”, EMA launched an enhanced fast-track monitoring system.
Under this system, each pharmaceutical company must appoint an Industry Single Point of Contact (i-SPOC), who will report to EMA all current and anticipated shortages of crucial medicines used (see Regulation (EU) 2022/123).
Registering an i-SPOC:
- Companies must register their i-SPOC in EMA’s IRIS online platform by 2 September 2022.
- Companies can log in to IRIS using their EMA account credentials.
Marketing authorisation holders who do not have an EMA account need to create one first via EMA's Account Management portal. This could take 5-10 working days.
Guidance on how to register an i-SPOC:
For technical support, contact the EMA Service Desk.
Lists of critical medicines: