No. Uploading data on behalf of a non-EU/EEA Marketing Authorisation Holder (MAH) is not permitted.
Why is this not allowed?
Under Commission Delegated Regulation (EU) 2016/161 and the EMVO OBP requirements, only MAHs that are domiciled within the EU or EEA are eligible to be affiliated with an On-boarding Partner (OBP).
Specifically:
OBP-affiliated MAHs must be established in the EU/EEA
OBPs are only authorised to upload data to the repositories system for MAHs that meet this requirement
This requirement is defined in the EMVO OBP definition (point 6) and applies to all OBPs without exception.
Important reminder regarding the United Kingdom
As of 1 January 2025, the United Kingdom is no longer considered part of the EU/EEA for the purposes of EMVS onboarding and data upload.
As a result:
UK-domiciled MAHs do not meet the EU/EEA domicile requirement
OBPs must not upload data on behalf of UK MAHs unless there is an EU/EEA-domiciled MAH entity in scope
What should I do if non-EU/EEA MAHs are still listed?
If your OBP Portal or EU Hub data still contains MAH information related to non-EU/EEA entities, you must update your records accordingly.
Please refer to the following articles for step-by-step guidance:
Keeping MAH information accurate ensures compliance with regulatory requirements and prevents onboarding or data upload issues.