EMA is pleased to announce further updates on parallel distribution notification forms in IRIS and changes to the public register for parallel distribution notices.
- IRIS submission forms for initial notification, safety update and annual update were updated in section “Documents from Applicant” where applicants are required to indicate the document type (mock-up of outer packaging, mock-up of inner labelling and package leaflet) and the language(s) of these documents.
For detailed guidance please refer to IRIS user guide for parallel distribution applicants which is updated accordingly.
- Register of Parallel Distribution Notices · IRIS (europa.eu) was updated with addition of re-packager field to allow database search now also by re-packager name. Respectively, re-packager column is also included in the list of search results which allows you to export the details of parallel distribution notices in Excel.
More information is available in the updated IRIS user guide for parallel distributors.
For technical support with submission process or data in the public register, please log a ticket in Service Desk; for general enquiries, please send us a question. or post a new thread in the IRIS Forum “General Discussion and Self-Help”.
