List of Reference Products

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    Can the MHRA advise as to whether they plan to publish and maintain a current listing of Reference Products for the UK?

    With regards to reference product updates, it is clear that this applies to products approved under Art 10.1 (generic), Art 10.3 (hybrid) and Art 10.4 (biosimilar). In addition, the Notice to Applicants also says that this should also be done for applications submitted under Art 10.C (informed consent).

    My question is whether the MHRA still considers the NtA applicable for the UK, since 01Jan2021?


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