RegOpsPro™

Unlicensed Medicines Guide™

A practical model for special clinical need, lawful sourcing, quality evidence, supply decisions, traceability and continuing oversight.

Open Unlicensed Medicines WorkspaceView Operating Model™
Special clinical needSource assuranceTraceabilityContinuing need

What this guide is for

UK human-medicines specials. Clinical-trial supply, EAMS, pharmacy exemptions and veterinary medicines need their own applicable route. Licensed-product import assurance remains in the RP-I model. Store references to clinical records, not patient-identifiable information.

How to use it

Read the judgement behind each stage, challenge your current arrangements and use the workspace to capture evidence, decisions and owned actions. Transfer approved outputs into your authorised system.

The implementation sequence

Work through the eight stages and revisit earlier decisions when the facts change.

1

Confirm the bona fide special clinical need

Start with the documented special clinical need and an unsolicited request from an appropriate prescriber. Establish why a suitably authorised medicine cannot meet that need; commercial preference is not a clinical justification.

Separate this assessment from off-label use of an authorised product, clinical-trial supply and routine wholesale sourcing. Use a reference to the controlled clinical record; do not enter patient-identifiable data in this working workspace.

Put it into practice

  • Record the requesting role and controlled request reference.
  • Describe the unmet need without patient identifiers.
  • Ask the clinical decision-maker to resolve missing justification.
  • Set a review trigger for an appropriate licensed alternative.
Control point
Is the need sufficiently supported to progress sourcing? Price or marketing preference presented as special need.

Working output: A documented special-need basis that can be independently reviewed.

2

Select and justify the legal supply route

Map the product movement and every activity: manufacture, assembly, import, holding and wholesale supply. Check the authorisation held by the party performing each activity and the scope of the premises.

The import notification process is separate from clinical justification and does not confer a marketing authorisation. Apply the current MHRA requirements for origin, product and route, including additional controlled-drug permissions where relevant.

Put it into practice

  • Draw the physical and contractual supply chain.
  • Match each activity to current authority evidence.
  • Record notification reference, quantities, timing and any MHRA conditions.
  • Escalate uncertainty before ordering or dispatch.
Control point
Can this exact route operate within current authorisations? Treating a notification acknowledgement as product approval.

Working output: A route decision showing the legal basis, accountable parties and limitations.

3

Assess the product and source

Define the exact medicine, strength, form, formulation and pack to be sourced. Confirm manufacturer identity, manufacturing site and source-country status; an overseas authorisation is evidence to assess, not a UK authorisation.

Qualify the supplier independently and reconcile invoice, pack, manufacturer and route. Differences in language, excipients, concentration or measuring device can create clinically important ambiguity.

Put it into practice

  • Create an identity and presentation specification.
  • Verify source and manufacturer evidence.
  • Document translation and label review needs.
  • Resolve substitutions with the authorised clinical and quality reviewers.
Control point
Is the proposed product the one justified by the request? A trading name mistaken for the manufacturer.

Working output: A product-and-source assessment with identified risks and controls.

4

Review quality and safety evidence

Build a proportionate evidence package around the product’s quality risks: origin, manufacture, specification, batch documentation, stability, sterility where relevant and distribution conditions.

Record what evidence is available, what is missing and the implications. A certificate of analysis is one component of assurance; it does not close every manufacturing, stability or transport uncertainty.

Put it into practice

  • Index the evidence by product and source.
  • Check batch documents against the agreed specification.
  • Record gaps, requests and the proposed mitigation.
  • Escalate unresolved quality risks to the authorised decision-maker.
Control point
Does the evidence support progression or is supply on hold? A generic certificate reused for a different batch.

Working output: A quality evidence pack with gaps, risk rationale and stop conditions.

5

Make and record the supply decision

Bring the clinical request, route assessment, source qualification and quality evidence together before supply. Define the product, quantity, recipient, conditions and approval responsibilities.

Keep clinical prescribing decisions, legal supply checks and operational stock disposition distinct. The workspace prepares the decision trail; the formal approval remains in the authorised system.

Put it into practice

  • Prepare a single referenced decision summary.
  • Record unresolved conditions as holds with owners.
  • Confirm quantity and recipient against the request.
  • Transfer the approved decision reference to the operating record.
Control point
Approve, approve with justified conditions, defer or reject? Commercial approval substituted for quality approval.

Working output: A traceable supply decision with rationale, limitations and reviewer.

6

Maintain distribution and patient traceability

Maintain a connected record from source and batch to each recipient, including receipt, supply, quantity and dates. Keep patient-level traceability in the appropriate clinical or dispensing system and reference it securely.

Control storage, segregation, expiry, transport and reconciliation throughout distribution. Traceability must work in both directions during a defect or recall investigation.

Put it into practice

  • Record batch and recipient at the point of movement.
  • Check label, storage and expiry requirements at handover.
  • Test retrieval using a sample batch.
  • Resolve discrepancies and preserve the controlled record references.
Control point
Is the trace complete enough to supply or recall confidently? Batch number absent from dispatch records.

Working output: A complete traceability record capable of supporting rapid recall.

7

Manage complaints, defects, recalls and safety signals

Distinguish a service complaint, suspected quality defect and suspected adverse reaction, while recognising that one report can involve all three. Establish assessment, containment and reporting routes before an incident occurs.

Use current MHRA defect guidance and the appropriate safety-reporting process. Do not wait for a complete root cause before escalating a potentially serious issue through the applicable route.

Put it into practice

  • Record the initial facts, timings and product identifiers.
  • Contain implicated stock and trace distributed quantities.
  • Escalate to quality and clinical/safety roles.
  • Document notifications, reconciliation and follow-up.
Control point
Is immediate containment or recall assessment required? Waiting for a supplier response before internal escalation.

Working output: An event-control record linking signal, containment, notification, investigation and closure.

8

Review governance and continued need

Review whether each continuing supply still has a valid special-need basis, suitable source and defensible quality evidence. Include product changes, availability of licensed alternatives, volume trends and feedback.

Make management oversight focus on unresolved risk and control effectiveness. Periodic review frequency should reflect the product and supply risks rather than an arbitrary calendar alone.

Put it into practice

  • Set risk-based review and change triggers.
  • Sample repeat orders and source files.
  • Trend defects, exceptions and quantities.
  • Assign actions and verify their effect on later supplies.
Control point
Continue, restrict, change source or cease the route? An unchanged annual sign-off despite material supply changes.

Working output: A governance review showing continued justification, risks and corrective decisions.

Sources and applicability

UK human-medicines specials. Clinical-trial supply, EAMS, pharmacy exemptions and veterinary medicines need their own applicable route. Licensed-product import assurance remains in the RP-I model. Store references to clinical records, not patient-identifiable information.

Sources checked 21 September 2026. Read historical commentary alongside current official requirements. RegOpsPro scenarios are illustrative working examples. Formal approvals and controlled records remain in your authorised QMS.

View source coverage and knowledge-search scope

Working-workspace boundary. This supports assessment and evidence preparation. Accountable professionals retain decision responsibility; approved records remain in the authorised QMS.

Move from guidance to execution

Open Unlicensed Medicines WorkspaceOpen Unlicensed Medicines Practitioner Practitioner Practitioner Practitioner Practitioner Guide™