Mandatory Organisation Management Services (OMS) of your manufacturing information could delay your regulatory submissions
Two changes in data policies of EMA involving the use of SPOR/OMS should be taken into account for New MAAs and Variations:
> In the current eAF v1.25, the use of OMS will be mandatory as of November 1st, 2021, for Centralised Procedures. The EMA will not accept the use of free text for organisations from that date, although the eAF version keeps allowing it.
Moreover, a new release of eAF v1.26 is expected in December 2021. This version will not contain free text fields for organisations and data should be inserted from an OMS picklist. Version 1.26 will be mandatory as of January 1st, 2022 for human medicines and as of January 28th, 2022 for veterinary medicines.
> As of January 28th, 2022, EudraGMDP users from NCAs will no longer enter organisation data directly into the EudraGMDP database. Instead, they will select the relevant organization name and location address details, including the legally registered address of manufacturers/importers/distributors from OMS.
Therefore, it is necessary that applicants/holders check that organizations which should appear in the eAF and are within EudraGMDP, including manufacturers, importers and distributors of human and veterinary medicines and active substances in the EU and outside the EU are registered within OMS.
Asphalion services and solutions
Asphalion can support you in SPOR / OMS review and update, both for FDF and API manufacturers. In the case of FDF, we recommend to review the portfolio to check if the organisations are correctly loaded in OMS. After this review, we can do the insertions amendments as needed. In case of foreign manufacturers (FDF or API) not yet registered, we can also add the information to OMS on your behalf.
Asphalion offers knowledge and workforce to give strategic advice and review of current situation. This will allow to define how much is still needed to perform in order to have the Organisations information aligned and to avoid any inconvenience in current and future regulatory submissions.
For further information you can contact us here! ⬇️
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