The OMS mandatory use in the eAFs for all Human and Veterinary Centralised Procedure applications (e.g. initial MAAs, variations and renewals) as well as for other administrative procedures without eAFs (e.g. MAH transfers) and pre-submission activities (e.g. eligibility request, intent to submit an MAA)) has now been postponed to the 1st of November 2021 to enable Industry to submit without delay previously stated procedures.
In addition, we would like to also inform you that a new Q&A document on the mandatory use of OMS in Centralised Procedure will be published to provide applicants/MAHs with all necessary background and guidance to implement the above.
We would like to highlight the importance of the above deadline in order to facilitate the implementation of two other significant and legally binding projects, namely CTIS and the UPD (by end of January 2022) for which implementation of OMS by the end of 2021 is critical.