A practical model for special clinical need, lawful sourcing, quality evidence, supply decisions, traceability and continuing oversight.
Connect each requirement to the evidence reviewed, the judgement made, the action taken and the follow-up that demonstrates control.
Capture the prescriber's request and why an appropriately authorised medicinal product cannot meet the individual patient's special need.
Verify product identity, manufacturer, source-country status, supplier legitimacy, formulation, pack, language and provenance.
Confirm the request, legal route, source, evidence, quantity and accountable review before supply.
Trend products, prescribers, quantities, sources, repeat requests, complaints and risks to detect routine or inappropriate use.
Use the Practitioner Guide™, workspace and linked sources to build a reviewable evidence trail.
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.
Discuss scope, governance and implementation support for your organisation.
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