Medicines & Devices amendments and continuing conditions

HLT.05directorateUnion-wide competence

Purpose and competence

Medicines & Devices amendments and continuing conditions 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/R3
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

A change that may reopen the medicines & devices integrated programme finding

Positive evidence for one indication is advertised as general approval; limit the supported product finding.

Instrument affected: Medicines & Devices integrated programme finding
Receiving custodian: Medicines & Devices programme coordinator

Access to this record

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