Responsible Person (Import): Why You Must Get One Now

If you import medicines into the United Kingdom, your next shipment could be stopped before it even leaves the port. Not because of product quality issues, but because of a missing role on paper: the Responsible Person (Import).

Since post-Brexit regulations came into force, the RPi has become the linchpin of legal pharmaceutical importation. Without one, even the most compliant manufacturer or distributor risks losing access to the UK market. The Responsible Person (Import) exists for one reason: to ensure imported medicines meet MHRA and HMRC standards before release into the supply chain.

At Inglasia Pharma Solutions, we act as the RPi for companies importing human medicinal products into the UK, making sure every shipment meets the GDP obligations set by the MHRA and that all customs documentation aligns with HMRC requirements.

The Growing Risk Around Medicine Imports

Pharmaceutical imports are under more scrutiny than ever. The UK’s regulatory framework has evolved since leaving the EU, and that evolution brings extra accountability for importers.

When you import QP-certified products from the European Economic Area (EEA), you must have an RPi appointed. The role is not optional. It’s mandated by the Human Medicines Regulations 2012, as updated through MHRA guidance.

Without this position formally assigned and approved, your products cannot legally move into the UK supply chain. In some cases, shipments are delayed for weeks while companies scramble to prove compliance.

Each day of delay costs storage fees, customer penalties, and potentially damages relationships with NHS buyers or wholesale partners.

Why the Responsible Person (Import) Role Exists

The Responsible Person (Import) was created to ensure that imported medicinal products meet equivalent safety and quality standards to those manufactured in the UK.

Under MHRA guidance, the RPi verifies that:

The product is sourced from a country with a Mutual Recognition Agreement (MRA) or approved status.
Each batch has a valid QP certification from the manufacturing site.
Storage, transport, and documentation align with GDP standards.
The import site holds the correct authorisation, usually a Wholesale Dealer Authorisation (WDA(H)).
Customs documentation and HMRC import data are accurate and reconciled with company import records.

In short, the RPi acts as the safeguard between international supply and domestic distribution. Without this checkpoint, medicines could enter the UK market without proven equivalence to UK GMP standards.

The Difference Between RP and RPi

This confusion causes most compliance failures.

An RP (Responsible Person) ensures wholesale distribution within the UK complies with GDP. An RPi, on the other hand, ensures imports meet MHRA and HMRC import rules before distribution even begins.

If you’re moving finished medicines from a European manufacturing site into Great Britain, the RPi is the one who signs off that the batch is acceptable for the market.

Many importers assume their RP covers this automatically. But unless that person is explicitly named as an RPi on the WDA(H) licence, they cannot perform import release activities.

This oversight can cause serious issues during MHRA inspections, and it’s surprisingly common among mid-size importers.

What the RPi Actually Does

The RPi carries a wide range of legal and operational responsibilities. Here’s what they oversee every single time a product crosses the border.

1. Batch Verification

The Responsible Person (Import) checks that every batch imported from an approved country is accompanied by a valid QP certification. They confirm that each batch meets the marketing authorisation and that the product has not been tampered with or mishandled during transit.
If a single certificate is missing or incomplete, the RPi has the authority to halt distribution until the issue is resolved.

2. Supplier Qualification

Only approved suppliers can be part of the import chain. The RPi ensures that each partner, whether manufacturer, wholesaler, or transporter, meets GDP and GMP standards.
They verify supplier audits, transport validation, and temperature monitoring records.

3. Import Site Authorisation

Every physical location used for import activities must hold the correct licence. The RPi checks this, confirming that the site is covered under the company’s WDA(H) and that responsibilities are defined in writing.

4. Customs Documentation and HMRC Reconciliation

This is one of the most common areas of MHRA findings today and one that many importers overlook.
The RPi must ensure that customs release paperwork, import declarations, and HMRC import data are retained, reviewed, and reconciled with the company’s internal import activity logs.

In practice, this means:

Verifying that each consignment cleared through UK customs under the RPi scheme has complete supporting documentation (e.g., C88 forms, airway bills, customs entry references).
Ensuring import quantities and batch details reconcile precisely with HMRC import records.
Maintaining an auditable trail that demonstrates every imported batch was lawfully brought into the UK and released under the correct authorisation.
Regularly reviewing discrepancies and implementing corrective actions when import data does not match internal records.

This reconciliation confirms the accuracy of import records and ensures no gaps exist between HMRC declarations and internal quality systems.
Failure to maintain or reconcile these records has led to multiple recent MHRA inspection findings where importers could not demonstrate traceability between customs clearance and product release.

5. Regulatory Liaison

The RPi acts as the named contact for MHRA inspections. They must be ready to present customs records, respond to findings, and demonstrate that import processes remain under control.

6. Deviation and Recall Oversight

If anything goes wrong, from temperature deviations to packaging or customs errors, the RPi ensures that CAPAs are raised and managed correctly. In a recall, they coordinate between the licence holder, MHRA, and affected parties.

In short, the RPi acts as the gatekeeper for pharmaceutical integrity.

The Cost of Not Having a Responsible Person (Import)

Let’s look at what happens when a company skips or delays appointing a Responsible Person (Import):

Shipment Holds: Customs or the MHRA can block imports without a valid RPi declaration.
Licence Suspension: The company’s WDA(H) can be suspended if import activities are conducted illegally.
Product Recalls: If a non-verified batch enters distribution, it can trigger recalls, damaging both reputation and profitability.
Loss of Market Access: Without an RPi, products cannot legally reach patients, regardless of their origin or quality.
Inspection Findings: Missing customs reconciliation records are now a frequent deficiency point in MHRA inspections.

It only takes one inspection to uncover the gap and one missing customs record to trigger enforcement action.

Why the RPi Matters More After Brexit

Before Brexit, most UK companies could rely on EU batch certification and RP oversight alone. Post-Brexit, that changed.

The MHRA introduced the Responsible Person (Import) to ensure that imported medicines meet domestic verification standards.
Now, even if a product is QP-certified in an EU country, it cannot be sold in Great Britain without an RPi confirming equivalence, verifying documentation, and ensuring customs compliance.

This added step protects patients but places a greater burden on importers. Many businesses have since outsourced the RPi role to specialist service providers who already meet MHRA eligibility criteria.

The Qualification and Authority of the RPi

The MHRA defines strict qualifications for the Responsible Person (Import). The RPi must:

Hold a relevant scientific or technical degree.
Have at least one year of GDP-related experience in import or distribution.
Demonstrate a full understanding of GDP, MHRA, and HMRC import requirements.
Be continuously available to perform duties or delegate to an approved deputy.

The RPi must also appear on the company’s licence with MHRA approval. This is not a symbolic title, it’s a legal accountability position.

What Makes a Good RPi Partner

For importers that lack internal capacity, partnering with an external RPi service like Inglasia is a practical solution. But not all providers are equal.

When choosing an RPi partner, look for:

Documented MHRA compliance history.
Experienced personnel with GDP, GMP, and HMRC import knowledge.
Established QMS that aligns with your licence.
Transparent communication and audit readiness.
Capability to integrate into your import workflows.

This is where Inglasia Pharma Solutions provides value.
Our Responsible Person (Import) service covers the full compliance lifecycle from supplier qualification and batch review to customs documentation verification and MHRA liaison.

We work with licensed importers and manufacturers to ensure their imports remain compliant, documented, and uninterrupted. Our Responsible Persons maintain oversight so your business continues operating smoothly.

Common Myths Around the Responsible Person (Import)

Myth 1: Our RP covers import responsibilities.
Wrong. Unless your RP is officially named as an RPi on your licence, they cannot approve imports.

Myth 2: We only import from the EEA, so we’re exempt.
Even EEA imports require RPi verification and documentation under current MHRA guidance.

Myth 3: The role is optional for parallel importers.
All importers handling medicinal products for human use must have an RPi listed on their authorisation.

Myth 4: Customs reconciliation is the responsibility of finance.
Not anymore. The MHRA now expects the RPi to oversee and verify HMRC import record reconciliation as part of GDP compliance.

Myth 5: Outsourcing the RPi increases inspection risk.
When done correctly, outsourcing actually reduces risk. An external RPi provider offers experienced oversight and consistent documentation standards.

How the RPi Protects Your Supply Chain

Think of the Responsible Person (Import) as your compliance firewall. Every check they perform prevents a potential failure that could cost far more later.

They:

Verify supplier integrity before goods move.
Ensure each batch carries proper QP certification.
Check customs clearance records align with HMRC import data.
Keep import documentation ready for audit at any time.
Manage deviations and recalls to protect patients and the company’s reputation.

With an RPi in place, you gain traceability, accountability, and assurance that your supply chain stands up to MHRA scrutiny.

Real-World Benefits of Early Compliance

Importers who secure RPi coverage early see measurable benefits:

Faster customs clearance. MHRA-compliant documentation means fewer delays.
Reduced internal workload. The RPi handles GDP verification, freeing internal QA teams.
Audit readiness. Having an external expert ensures your records always meet inspection standards.
Lower compliance costs. Preventing a single recall or suspension offsets the cost of ongoing RPi services.

Regulators expect importers to act proactively, not reactively. Companies that wait for enforcement letters pay the price later.

The MHRA’s Current Inspection Focus

During an inspection, the MHRA will review:

The appointment letter and competence record of your RPi.
Evidence that the RPi verified each batch and its associated customs release documentation.
Reconciliation between HMRC import data and internal import logs.
Records of supplier approval and transport validation.
Evidence that deviations and CAPAs were managed effectively.

If any of these are missing, it can trigger deficiencies or licence suspension.
That’s why partnering with a dedicated RPi provider ensures continuity, documentation accuracy, and compliance control.

Steps to Get RPi-Ready

If you’re preparing to appoint or transition your Responsible Person (Import), here’s a practical action plan:

Review your WDA(H) licence. Confirm if an RPi is named and approved.
Assess your imports. Identify all routes that involve EU or third-country imports.
Audit your current processes. Check batch records, supplier approvals, and customs reconciliation practices.
Engage an experienced provider. Choose a partner that already meets MHRA expectations.
Train internal staff. Make sure QA, logistics, and finance teams understand RPi and HMRC record requirements.

Completing these steps before your next shipment can prevent operational disruption.

Why Importers Choose Inglasia Pharma Solutions

Pharmaceutical importers work with us because they want peace of mind. Our Responsible Person (Import) service is built around one goal: ensuring every batch entering Great Britain meets GDP, MHRA, and HMRC compliance from start to finish.

At Inglasia Pharma Solutions, we handle the compliance documentation, review QP certificates, reconcile customs records, and liaise directly with regulators. You keep your business running; we keep it compliant.

With an established QMS, a team of trained Responsible Persons, and a strong compliance record, we help importers avoid the pitfalls that lead to costly delays.

The Bottom Line

Every importer faces the same choice: act now or face the consequences later.

Without a Responsible Person (Import), you’re taking unnecessary risk with your licence, your supply chain, and your reputation.
With one, you stay compliant, inspection-ready, and free to focus on your business.

Need help ensuring your imports meet MHRA and HMRC standards? Contact our RPi team today to keep your supply chain compliant and uninterrupted.