Pharmaceutical Companies
In compliance with the Delegated Regulation (EU) 2016/161, Original Pack Manufacturers and Parallel Distributors are required to upload unique identifiers and related information to the repositories system before their medicinal products are released for distribution. Acting as authorised entities, On-boarding Partners (OBPs) play a crucial role in this process by uploading ‘OBP Data’ on behalf of affiliated entities. This affiliation mandates that the Marketing Authorisation Holder(s) (MAH(s)) be connected to the OBP, ensuring a seamless flow of accurate information.
The OBP is permitted to upload OBP Data exclusively for affiliated entities, encompassing those holding marketing authorizations or parallel distribution notices/import licenses, within the framework of the OBP’s corporate structure. To initiate this data upload to the repositories system, OBPs must integrate their (IT) systems with the European Hub. This integration involves following EMVO’s comprehensive On-boarding Process, a series of steps designed to establish a secure and efficient connection.

The on-boarding process:
a high-level overview of the steps
Contractual On-boarding
Prior to establishing a connection with the EU Hub, the OBP is required to complete the signing of the OBP Participation Agreement (PA), accessible through the OBP Portal. The following three steps provide an overview of the contractual on-boarding process.
Technical On-boarding
After successfully completing the contractual on-boarding process, the OBP can proceed with establishing the technical connection between their system and the EU Hub.
Provide information
Provide initial company information
Legitimacy Check
Verification check
Participation agreement & invoice
Agreement in place & invoice
Technical on-boarding
OBP connection to the EU Hub