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Drug review identity
HLT.05.01 / office
Drug review
UnionDrug reviewDrug review

HLT.05.01 / PUBLIC SERVICE NETWORK

Drug review

Review a medicine for a stated clinical use against attributable efficacy and safety evidence.

HLT.05.01officeUnion-wide competence

Drug review / public remit

Review a medicine for a stated clinical use against attributable efficacy and safety evidence.

Receiving role
Drug review assessment lead
Public counterpart
Medicines & Devices

Choose your route

Office output: Medicine benefit-risk determination

Assessment file: Medicine benefit-risk determination

  • clinical studies
  • manufacturing controls
  • monitoring plan

Read the medicine benefit-risk determination specification →

A difficult drug review case

Illustrative case / HLT.05.01

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

Reporting and specialist powers

Competent parent
Medicines & Devices
Local public authority
Health & Biomedical Commission
Receiving evidence
clinical studies; manufacturing controls; monitoring plan
Assessment question
Positive evidence for one indication is advertised as general approval

Public records and accountability

HLT.05.01/REG
Records and reasoned determinations

Medicine benefit-risk determination

HLT.05.01/CONTACT
Contact the competent office

Accessible assistance, evidence alternatives, institutional handoffs and review.