From request to review
Establish the service need
For review a new medicine or device, record the requester, location, scope and responsible receiving office. The receipt identifies the clock and competent jurisdiction.
Gate: Location and competence are recorded
Owner: Health & Biomedical CommissionRecover and verify the record
Assess clinical evidence; reconcile it with safety evaluation and manufacturing quality record. A missing document has an explicit alternative-evidence route rather than silent rejection.
Gate: Evidence is complete or an alternative is agreed
Owner: Health & Biomedical CommissionAgree the receiving service
Ask Bioethics & Future Generations Council for the finding within its own powers. The consultation records the specific unresolved question, evidence version and requested response.
Gate: A specialist finding is recorded
Owner: Bioethics & Future Generations CouncilProtect continuity and consent
Only authorized clinicians see identifiable health records Publish or privately communicate the resolution, including dissent and consent limits.
Gate: The stated safeguard is resolved
Owner: Planetary Protection AuthorityIssue the personal determination
A reasoned product review with conditions and monitoring duties. The decision also names the accountable official role, effective event, conditions, review office and follow-up duties.
Gate: Reasons, conditions and review route are available
Owner: Health & Biomedical CommissionCorrect, review or transfer
Preserve the source record, decision reasons and conditions for review a new medicine or device. A service complaint routes to the Ombudsman; a contested legal restriction routes to the Union Court.
Gate: Follow-up owner and record custody are named
Owner: Union Ombudsman
Exceptions and alternate routes
Required evidence is unavailable
Record the missing item and propose a witness, existing register reference or independently verified substitute. The completeness review remains open.
Interplanetary communication is interrupted
Record local receipt time and the delegated action available. Preserve a mirrored log for later reconciliation; do not invent a remote approval.
An adverse finding affects the requester
Provide the finding, allow a response, disclose the review route and preserve essential service continuity where applicable.
Institutional interfaces
Independently evaluates decisions with consequences for human dignity and future populations.
Maintains common reference systems so institutions and equipment can work together.
Protects potential life, scientific evidence and inhabited biospheres from contamination.
Start the record
Prepare a requestThe assessment behind the stage diagram
Biomedical reviewers examine quality, evidence limitations, relevant standards, clinical stewardship and monitoring. Human study ethics and habitat installation can require separate findings.
Study evidence, manufacturing or device provenance and the proposed clinical purpose are assessed together. A laboratory finding does not automatically support use in every environment or population.
Possible decisions and what follows
Bounded recognition, conditional use with monitoring, further evidence or refusal with reasons and a review route.
Material changes in design, intended use or evidence trigger the declared review. Adverse findings remain attached to the original version.
Duties after the finding
Keep the scope accurate
Tell the receiving office about a material change in location, activity, operator, record custodian or requested result. The original receipt remains in the history.
Respect source custody
Provide purpose-specific references and authorised representations. Personal, clinical, commercial and protected scientific records have different access scopes.
Respond to a qualified finding
Read the conditions and the institution that owns them. A request for further evidence identifies the specific unresolved issue and the route for an alternative.
Preserve the follow-up
Material changes in design, intended use or evidence trigger the declared review. Adverse findings remain attached to the original version.
Disagreement, assistance and evidence alternatives
A completeness query names the unresolved evidence and the alternative the receiving office can assess. An administrative complaint concerns service handling; a legal appeal concerns a finding and its competent remedy. A public petition asks a representative institution to examine a wider issue.