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Drug review identity
HLT.05.01 / office
Drug review
UnionDrug reviewServices and requests

HLT.05.01 / PUBLIC SERVICE NETWORK

Services and requests

Drug review: public intake, evidence routes and competent specialist services.

HLT.05.01officeUnion-wide competence

Choose your route

Office output: Medicine benefit-risk determination

Our intake route

clinical studies; manufacturing controls; monitoring plan

Positive evidence for one indication is advertised as general approval

Arrange a care referral between worlds

Competent service: Health & Biomedical Commission

Prepare a request Eligibility and evidence →Process and exceptions →

Access isolation and mental-health support

Competent service: Health & Biomedical Commission

Prepare a request Eligibility and evidence →Process and exceptions →

Review a new medicine or device

Competent service: Health & Biomedical Commission

Prepare a request Eligibility and evidence →Process and exceptions →

Request a cross-region medical surge

Competent service: Health & Biomedical Commission

Prepare a request Eligibility and evidence →Process and exceptions →

Receiving role for medicine benefit-risk determination

Drug review assessment lead

Contact about medicine benefit-risk determination →

Authority for medicine benefit-risk determination

Subject-specific assessment
Positive evidence for one indication is advertised as general approval
Shared legal framework
Health & Biomedical Commission / powers
Handling complaint
Union Ombudsman
Contested legal finding
Union Court of Justice