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HLT / commission
Health & Biomedical Commission
UnionHealth & Biomedical CommissionMedicines & Devices

HLT / PUBLIC SERVICE NETWORK

Medicines & Devices

Medicines & Devices brings together drug review, medical device review and cold-chain standards.

HLTcommissionUnion-wide competence

The public purpose

Medicines & Devices brings together drug review, medical device review and cold-chain standards.

Operational teams

HLT.05.01
Drug review

Review a medicine for a stated clinical use against attributable efficacy and safety evidence.

HLT.05.02
Medical device review

Assess a medical device's claimed function, intended users and supported receiving setting.

HLT.05.03
Cold-chain standards

Define custody and condition evidence for temperature-sensitive clinical supplies.

Programme responsibilities

Assessment evidence
Medicine benefit-risk determination; Medical-device use finding; Clinical cold-chain standard
Accountable output
Medicines & Devices integrated programme finding
Programme custodian
Medicines & Devices
Independent review
Union Ombudsman

Requests and referrals

SVC-011
Arrange a care referral between worlds

An agreed treatment handoff and travel-care arrangement.

SVC-012
Access isolation and mental-health support

A confidential support referral and follow-up plan.

SVC-013
Review a new medicine or device

A reasoned product review with conditions and monitoring duties.

INT-003
Request a cross-region medical surge

A capacity-sharing plan with clinical responsibility at each handoff.

Medicines & Devices / division of work

HLT.05.01

Drug review

Review a medicine for a stated clinical use against attributable efficacy and safety evidence.

Accountable output
Medicine benefit-risk determination
HLT.05.02

Medical device review

Assess a medical device's claimed function, intended users and supported receiving setting.

Accountable output
Medical-device use finding
HLT.05.03

Cold-chain standards

Define custody and condition evidence for temperature-sensitive clinical supplies.

Accountable output
Clinical cold-chain standard

Authority for medicines & devices integrated programme finding

Subject-specific assessment
Positive evidence for one indication is advertised as general approval
Shared legal framework
Health & Biomedical Commission / powers
Handling complaint
Union Ombudsman
Contested legal finding
Union Court of Justice

Choose your route

Office output: Medicines & Devices integrated programme finding