EMA has launched a secure online platform for submitting and managing parallel distribution notifications through the recently implemented IRIS Regulatory & Scientific Information Management Platform. Starting today, 11 February, parallel distributors are required to use IRIS that was developed in June 2018 for orphan designation applications and will now be gradually rolled out to cover other regulatory and scientific procedures.
Parallel distribution is the distribution of a centrally authorised medicine from one Member State to another independently of the marketing authorisation holder. EMA checks parallel distribution notifications and maintains a public register that holds up-to-date information on the notices issued.
IRIS will provide a single space for parallel distributors to submit and manage information and documents related to the parallel distribution processes. The streamlining of the processes will reduce the time needed for parallel distributors to prepare and submit notifications and ensure better data quality through integration with other EMA systems. Applicants will be able to check the status of their notifications across multiple devices and will receive automatic updates when their status changes.
In view of the launch of this new module and the upcoming relocation to the Netherlands, EMA is temporarily suspending the submission of parallel distribution annual updates from 1 February to 30 April 2019.
In addition, no physical notice letters will be posted from 15 February until 1 April 2019. Following this period, stakeholders will have the opportunity to request individually signed notice letters, should these be required.
EMA has published detailed guidance on how to access and use IRIS for parallel distribution notifications and is also offering virtual training sessions.