INFARMED Deliberation No. 1425/2025 updates the regime for Medical Gases
Don’t miss our content
SubscribeThe new Regulation on Medical Gases has recently been approved in Portugal by INFARMED Deliberation No. 1425/2025 - which revokes the regulation previously in force (Deliberation No. 56/CD/2008) - and will enter into force on December 2, 2025.
This new regime represents a thorough overhaul, aligning national regulation with current demands, with a particular emphasis on safety, traceability, and quality throughout the medical gases lifecycle.
Scope and subject matter
The regulation now clearly and comprehensively covers all stages: manufacturing, packaging (primary and secondary), labeling, package leaflet, technical oversight, transport, distribution, marketing, supply, and home delivery of medical gases.
Home delivery is expressly regulated through the inclusion of Good Home Distribution Practices (“BPDD”) in the new legal text.
Manufacturing, authorization, and technical director
Manufacturing remains subject to authorization by INFARMED, now with a requirement to identify precisely the authorized sites and reservoirs. Any change must be communicated electronically within the prescribed period.
The role of the technical director takes center stage: they must be a specialized pharmacist, registered with the respective professional body, and may not serve as technical director at more than five authorized sites simultaneously.
Technical responsibility rests with the technical director even if tasks are delegated - the supervision and quality control, storage, filling, and transport remain under their purview.
Manufacturing in healthcare institutions and clinical use
The regulation creates a dedicated framework for the manufacturing of medical gases within healthcare institutions when produced by medical devices. These activities are subject to prior notification, implementation of a quality management system, documentation, traceability, and the assignment of clear responsibility to a pharmacist with defined functions.
Home distribution
Home distribution is no longer a mere normative reference and now has detailed rules: storage, transport in accordance with national/international dangerous goods standards, lot, cylinder, and valve traceability, monitoring, returns, complaints, and training of the responsible professionals.
This regulation seeks to ensure that delivery to the patient at home meets standards equivalent to those of a conventional medicinal product - with the necessary quality and safety.
Quality, control, traceability, and safety
The new regulation introduces clear requirements for the traceability of gases - from the lot, cylinder, reservoir, or distribution system to the final product. Labeling and documentation must comply with the regulation’s requirements, including European good practice standards.
Entities that produce or distribute medical gases must have a robust quality control system, appropriate storage, equipment maintenance, and organized, updatable documentation - all of which strengthens patient protection.
Transition and adaptation period
Entities already carrying out activities covered by the regulation have one year to adapt to the new provisions, particularly with respect to technical oversight and the BPDD.
Don’t miss our content
Subscribe