PhaRegistrum · Originally published on 10/12/2025
The new medicinal gases regulation has recently entered into force, updating the framework for manufacture, packaging, labelling, transport, distribution, marketing, supply and home delivery.
It strengthens quality, safety and traceability from production facilities to patients’ homes, incorporates Good Home Distribution Practices and clarifies technical teams’ responsibilities.
Entities carrying out covered activities have one year to adapt.
Need support? PhaRegistrum accompanies the entire adaptation process.
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