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EU HUB | Can a UK pharmaceutical company act as an OBP for non-UK MAHs after 31 December 2024, should the Regulation (EU) 2023/11821 enter into force on 1 January 2025*
EU HUB | Can a UK pharmaceutical company act as an OBP for non-UK MAHs after 31 December 2024, should the Regulation (EU) 2023/11821 enter into force on 1 January 2025*
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Written by Jessica Clifford
Updated over 8 months ago

Yes, a UK pharmaceutical company can act as an OBP for non-UK MAHs as long as Appendix 4 โ€“ Addendum only applicable to non-EEA OBPs from the Participation Agreement (PA) is signed.

*The date is subject to the relevant written guarantees from the UK being in place.

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