HLT.05.01officeUnion-wide competence
Record categories
HLT.05.01/R1
Medicine benefit-risk determination
HLT.05.01/R2Scope, source custody, review and publication duties.
Drug review evidence and source custody
HLT.05.01/R3Scope, source custody, review and publication duties.
Drug review amendments and continuing conditions
Scope, source custody, review and publication duties.
Publication and custody
Shared source-custody and accessibility rules · Public powers and review routesRequest a record
Prepare a records requestThe evidence behind medicine benefit-risk determination
- clinical studies
- manufacturing controls
- monitoring plan