PhaRegistrum · Originally published on 17/03/2026
Decision No. 1425/2025 entered into force on 2 December 2025, replacing the previous regulation and clarifying every stage of the medicinal gases lifecycle: manufacture, authorisation, premises and equipment, labelling and leaflets, traceability, transport and distribution, and home delivery.
Existing operators have one year to adapt to the new provisions, including technical management and Good Home Distribution Practices.
Manufacture using medical devices for clinical use now requires prior notification to INFARMED, I.P. Home distribution requires notification through the Licenciamento+ portal.
PhaRegistrum supports the entire adaptation process.
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