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RE: Add an additional member state to a parallel authorization
We have the answer from EMA, I post it here for everyone in case you have the same question :
"Additional member states of origin (MSO) can be added during an annual update procedure. The same rule also applies to adding member states of destination (MSD).
Please note that an annual update is a “DO and TELL” procedure. A parallel distributor can implement changes and only inform the Agency about these changes with the next annual update.
For more information on annual updates and other parallel distribution procedures, please refer to the PD FAQ, which can be found in the link below: https://www.ema.europa.eu/en/human-regulatory/post-authorisation/parallel-distribution/frequently-asked-questions-about-parallel-distribution#initial-notification-section"
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Add an additional member state to a parallel authorization
We submitted 2 requests for parallel distribution authorizations one month ago.
We have now the initial notices for both of them but we would like to add countries in the member states of origin.
We did not find any guidance on how to proceed via Iris platform, could you please indicate us how to proceed?
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