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EMVO On-Boarding Partner (OBP) – Definition and Eligibility

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Written by Lorenzo Mari
Updated this week

An On-Boarding Partner (OBP) is the entity that contracts with EMVO and represents one or more Marketing Authorisation Holders (MAHs) within the EMVS onboarding process.

Core Requirements for an OBP

An entity acting as an OBP must fulfil the following conditions:

  1. Contracting Entity
    The OBP is the contracting party with EMVO and concludes the Participation Agreement (PA).

  2. Legal Authority
    The OBP must be legally authorised to sign the PA on behalf of one or more MAHs.

  3. Affiliation Requirement
    The OBP must be affiliated with the MAH or group of MAHs it represents.

  4. Binding of OBP Affiliates
    All OBP Affiliates must formally agree in writing to be bound jointly and severally with the OBP by all terms, limitations, and conditions of the Participation Agreement.

  5. Eligible MAH Groups
    The MAHs represented by an OBP may include:

    • Marketing Authorisation Holders / Original Pack Manufacturers

    • Holders of a Parallel Distribution Licence or Distribution Notice

    • Parallel Distributors

  6. Location of the OBP
    The OBP must be domiciled in Europe (EEA/EU) or in the United Kingdom.
    A European or UK-registered MAH can therefore act as an OBP if requirements 1–5 above are fulfilled.

Specific Case: UK OBPs Representing Non-UK MAHs

Following Regulation (EU) 2023/1182, which entered into force on 1 January 2025, a UK pharmaceutical company may continue to act as an OBP for non-UK MAHs under the following condition:

  • The Participation Agreement Addendum applicable to non-EEA OBPs (Appendix 4) must be signed.

This ensures that non-EEA OBPs remain contractually bound to EMVO requirements while representing MAHs in the EMVS framework.

Definition of Affiliation

For the purposes of the Participation Agreement, Affiliation means that an entity:

  • Controls,

  • Is controlled by, or

  • Is under common control with

another entity.

Control refers to:

  • Direct or indirect ownership of 50% or more of shares or ownership interests, or

  • The statutory or de facto authority to exercise decisive influence over:

    • the appointment of the majority of directors or managers, or

    • the strategic orientation or policy of the entity,

provided that such control is sufficiently demonstrated and accepted at EMVO’s discretion.

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