Drug review evidence and source custody

HLT.05.01officeUnion-wide competence

Purpose and competence

Drug review evidence and source custody is maintained for Drug review. Its scope follows the office’s mandate: Review a medicine for a stated clinical use against attributable efficacy and safety evidence.

Positive evidence for one indication is advertised as general approval

Record specification

Record identifier: HLT.05.01/R2
Responsible custodian: Drug review
Source evidence: clinical studies; manufacturing controls; monitoring plan
Decision output: Medicine benefit-risk determination
Publication status: Draft record specification / no signed decision
Review route: Union Ombudsman / Union Court of Justice

Custodian and access

Drug review assessment lead → · Public records access procedure

Source catalogue for Drug review

Source 1: clinical studies
Source 2: manufacturing controls
Source 3: monitoring plan
Receiving purpose: Medicine benefit-risk determination

Access to this record

Drug review assessment lead / contact · Public records procedure · Common custody and accessible-format rules