Medicines & Devices evidence and source custody

HLT.05directorateUnion-wide competence

Purpose and competence

Medicines & Devices evidence and source custody is maintained for Medicines & Devices. Its scope follows the office’s mandate: Medicines & Devices brings together drug review, medical device review and cold-chain standards.

Positive evidence for one indication is advertised as general approval

Record specification

Record identifier: HLT.05/R2
Responsible custodian: Medicines & Devices
Source evidence: Medicine benefit-risk determination; Medical-device use finding; Clinical cold-chain standard
Decision output: Medicines & Devices integrated programme finding
Publication status: Draft record specification / no signed decision
Review route: Union Ombudsman / Union Court of Justice

Custodian and access

Medicines & Devices programme coordinator → · Public records access procedure

Source catalogue for Medicines & Devices

Source 1: Medicine benefit-risk determination
Source 2: Medical-device use finding
Source 3: Clinical cold-chain standard
Receiving purpose: Medicines & Devices integrated programme finding

Access to this record

Medicines & Devices programme coordinator / contact · Public records procedure · Common custody and accessible-format rules