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RP-I Guide™

A practical guide to the RPi assurance function and its interfaces with receipt control, evidence review, discrepancy escalation and wider WDA(H) governance.

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Regulatory scope. MHRA uses the term Responsible Person (import) (RPi). The statutory RPi assurance function applies to a Great Britain WDA(H) importing QP-certified human medicines from a country on the Approved Country for Import list. It confirms required QP certification and, where applicable, independent batch-release certification for biological products. Medicines sourced from Northern Ireland into Great Britain do not require RPi oversight. Wider supplier, transport, receipt, traceability and recall controls sit within the WDA(H) GDP quality system and may involve the RP, RPi, Quality and operations.

Practical guidanceImport oversightReceipt controlEvidence-led governance

What this guide does

It gives the RP-I a practical route for strengthening import oversight without reducing the role to a receipt checklist.

Where it adds value

It helps users identify where import accountability, evidence flow, quarantine, discrepancy escalation and governance need strengthening.

How it should be used

Use this guide for judgement and sequence, then use the workspace and RP-I tools to create working records and evidence outputs.

Recommended RP-I implementation path

The RPi assurance system should confirm the required QP certification before applicable product is placed on the Great Britain market. The wider WDA(H) GDP system should connect that assurance with receipt control, evidence review, status control and escalation.

Clarify import accountability and decision ownership

The RP-I needs a clear position across the import model: what the role owns, what is performed by QA, warehouse, supply chain or third parties, and which decisions must be escalated before product status changes.

FocusRole scope, importer responsibilities, authority and escalation triggers.

WatchOperational teams controlling imported goods without clear RP-I governance visibility.

RiskGoods are accepted or moved forward before accountability and evidence are clear.

Map import routes and evidence flow

The RP-I should understand each route, supplier/manufacturer interface, 3PL or carrier role, batch documentation route and where evidence is received, reviewed and retained.

FocusRoute risk, supplier interface, temperature evidence, batch status and document control.

WatchAssumptions that documentation will arrive complete, accurate and on time.

RiskEvidence gaps are discovered after receipt instead of being designed into the process.

Control the manufacturer / MAH / batch-evidence interface

The RP-I should be able to explain how evidence from the manufacturer, MAH, supplier or origin batch-certification process reaches the importing organisation, who reviews it, and what happens when it is incomplete, late or inconsistent.

Evidence routeDefine what is expected before receipt, during goods-in review and before onward movement.

WatchEvidence being treated as an admin follow-up rather than a control condition.

RiskProduct status decisions are made while key evidence remains unresolved.

Control receipt, quarantine and status decisions

Receipt is a practical operational control point within the wider WDA(H) system. The model should show how goods are checked, how quarantine is maintained, how RPi certification assurance is evidenced, and who can authorise status changes or escalation.

FocusGoods-in checks, documentation review, temperature evidence and quarantine status.

WatchTemporary workarounds becoming informal acceptance routes.

RiskUnverified product becomes available before review is complete.

Escalate discrepancies before they become governance failures

Import discrepancies should be visible early. Documentation mismatch, temperature uncertainty, quantity issues, damage, route delays or supplier failures need proportionate triage and clear ownership.

FocusSeverity, containment, owner, target date and decision rationale.

WatchRepeat minor issues being normalised because product supply pressure is high.

RiskInspection challenge because repeated import issues are not governed as a system signal.

Build an evidence pack and governance rhythm

Import oversight becomes stronger when the RP-I can show the evidence set, unresolved gaps, decisions taken and next actions in a concise governance pack.

FocusEvidence index, oversight log, discrepancy status and governance actions.

WatchEvidence held in separate systems with no inspection-ready narrative.

RiskThe process works operationally but cannot be explained clearly during inspection.

What the statutory RPi assurance covers

The RPi implements a system that confirms the required certification has taken place for applicable medicinal products imported into Great Britain from a country on the Approved Country for Import list.

Core assurance

Confirm that required QP certification has taken place and, for applicable biological products, that the required independent batch-release certification is available before the product is placed on the Great Britain market.

Delegated checking

The checking activity may be performed by trained personnel, but the RPi remains responsible for implementing the system and assuring that delegated checks remain effective.

Scope boundary.
Medicines sourced from Northern Ireland into Great Britain do not require RPi oversight. Importation from outside the UK without the applicable listed-country/QP-certification route may fall within manufacturing and import authorisation requirements rather than this RPi model. Confirm the product, licence and route before applying the workflow.

Designing the certification-assurance system

The system must define acceptable evidence, who checks it, when the check occurs, what is recorded and what prevents onward supply when assurance is incomplete.

Define acceptable evidence routes

Map evidence from the manufacturer, QP, MAH, supplier or controlled database. Define how authenticity, batch identity and completion of certification are established.

Reconcile product and batch identity

Connect the evidence to the correct product, strength, pharmaceutical form, batch, market and import transaction.

Control exceptions

Missing, late, contradictory or unverifiable evidence must trigger hold, investigation and escalation with clear decision authority.

Retain a reproducible record

The record should show who checked, what source was used, when the check occurred, the outcome and any linked discrepancy or decision record.

RPi interfaces within the wider GDP system

The statutory certification check is narrow, but it must operate inside an effective WDA(H) quality system.

RP and quality system

Define where RPi assurance ends and broader RP/GDP oversight begins, including supplier qualification, deviations, recalls, complaints, returns and outsourced activities.

Warehouse and status control

Receipt, quarantine, ERP status and physical segregation must prevent premature availability while required assurance or discrepancy review remains open.

Manufacturer, QP and MAH

Quality agreements and operating procedures should establish evidence format, transmission timing, exception contacts, change notification and escalation routes.

RPi governance and performance review

Routine review should demonstrate that the assurance system remains effective as routes, products, suppliers and volumes change.

Useful measures

Applicable batches imported and checks completed.
Checks completed before the defined status decision.
Missing, late or inconsistent certification evidence.
Import discrepancies by route, supplier and cause.
Delegated checker training and error trends.
Open actions, overdue investigations and repeat events.

Escalation triggers

Evidence cannot be authenticated or linked to the batch.
Product origin or licensing route is unclear.
Required independent batch-release evidence is absent.
Product status changed before assurance was completed.
Repeated failures indicate a supplier or system weakness.
A route or process change invalidates the approved control model.

Questions an inspector may test

The RPi should be able to demonstrate the system using recent real records rather than relying only on the procedure.

Scope and evidence

How are applicable products and import routes identified?
What evidence is accepted for QP certification?
How is independent batch release handled where applicable?
How is evidence connected to product and batch identity?
What prevents supply when evidence is incomplete?

People and effectiveness

Which checks are delegated and how is competence assured?
How does the RPi monitor the effectiveness of delegated checks?
How are discrepancies investigated and trended?
How are route, supplier and regulatory changes assessed?
Can a recent assurance decision be retrieved and explained?

Primary references

Use current MHRA guidance and applicable legislation as the controlling source. This guide provides an implementation structure rather than a substitute for regulatory requirements.

MHRA — Acting as a Responsible Person (import)

Current public guidance on scope, certification evidence, working as an RPi and becoming an RPi.

Open RPi guidance

MHRA — GDP and wholesale licensing

UK GDP expectations, inspection arrangements and the WDA(H) licensing framework.

Open GDP guidance Open licensing guidance

Content status.
Practical guide reviewed 21 August 2026. Confirm current approved-country, product and licensing arrangements before applying it to a live import route.

What good looks like

A strong RP-I operating model should make product entry control clear, evidence-based and easy to explain.

Strong indicators

RP-I accountability and escalation expectations are clear.
Receipt checks are linked to evidence review and product status decisions.
Manufacturer, MAH and batch-evidence interfaces are mapped and governed.
Quarantine and hold logic is practical, not just procedural.
Import discrepancies are triaged, contained and transferred into governance where needed.
Evidence packs show what was reviewed, what remains open and what decisions were taken.

Common weak points

Goods-in activity happens before RP-I oversight evidence is complete.
Documentation issues are treated as admin gaps rather than control signals.
Manufacturer, MAH or QP evidence routes are assumed rather than owned.
Temperature or route concerns are not escalated consistently.
Governance summaries list activity but do not show risk, decisions and follow-up.

Use the workspace for execution
The guide gives the qualified route and judgement points. The execution workspace turns that route into step-by-step implementation, actions, evidence and progress.

Use the tools for outputs
The RP-I toolkit is where users create readiness reviews, receipt checks, discrepancy logs, oversight logs, evidence packs and governance packs.

Ready to apply the guide?

Move into the full RP-I execution workspace when you are ready to turn the guidance into structured implementation activity.

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