Medicines and Healthcare products Regulatory Agency (MHRA) - MHRA implements new regulatory framework on decentralised manufacture

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2025

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ELSIBI

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OpenEdition

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info:eu-repo/semantics/openAccess



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adelage, « Medicines and Healthcare products Regulatory Agency (MHRA) - MHRA implements new regulatory framework on decentralised manufacture », ELSIBI, ID : 10.58079/13yf6


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MHRA has provided information on the new regulations for decentralised manufacture which come into effect on 23 July 2025. Point of care and modular manufacture are collectively called decentralised manufacture. These processes allow medicinal products to be made at or close to a patient’s location for administration of the medicine. Please find details including a webinar recording of these new MHRA regulations held on 28 January 2025 here. Guidance is expected to be published in early summer...

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