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Medicines & Devices identity
HLT.05 / directorate
Medicines & Devices

HLT.05 / PUBLIC SERVICE NETWORK

Medicines & Devices

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

HLT.05directorateUnion-wide competence

Medicines & Devices / public remit

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

Receiving role
Medicines & Devices programme coordinator
Public counterpart
Health & Biomedical Commission

Choose your route

Office output: Medicines & Devices integrated programme finding

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

Reporting and specialist powers

Competent parent
Health & Biomedical Commission
Local public authority
Health & Biomedical Commission
Receiving evidence
Medicine benefit-risk determination; Medical-device use finding; Clinical cold-chain standard
Assessment question
Positive evidence for one indication is advertised as general approval

Specialist offices

Public records and accountability

HLT.05/REG
Records and reasoned determinations

Medicines & Devices integrated programme finding

HLT.05/CONTACT
Contact the competent office

Accessible assistance, evidence alternatives, institutional handoffs and review.