Reference Listed Drug Supply

Reference Listed Drug
Supply UK
for Bioequivalence & Regulatory Work

Euro Biom trades exclusively in UK-licensed medicines, an MHRA WDA-licensed UK pharmaceutical wholesaler supplying UK-licensed reference products and innovator comparators for bioequivalence studies and regulatory dossiers.

MHRA WDA Licence No. WDA(H) 59239

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What is a Reference Listed Drug

The benchmark
against which generics
are measured.

A Reference Listed Drug is the originator branded medicine identified by a regulator as the benchmark for generic equivalence. In the United States, the RLD is the product designated in the FDA Orange Book under section 505(j) of the Federal Food, Drug, and Cosmetic Act.

In the European Union and United Kingdom, the equivalent concept is the reference medicinal product, the originator innovator authorised under a full marketing authorisation, against which a generic must demonstrate essential similarity, qualitative and quantitative composition equivalence and bioequivalence.

Each regulator decides which reference product it accepts. For a US ANDA that is the Orange Book product, so a UK-licensed pack may not qualify. Euro Biom sources UK-licensed reference products through the UK licensed supply chain, with batch details confirmed at quotation.

FDA Orange Book EU Reference Medicinal Product MHRA WDA Sourced Export Documentation

"A bioequivalence study is only as defensible as the comparator behind it. Sourcing the RLD from a regulated UK pharmaceutical wholesaler supports the provenance of a downstream submission."

Who Needs RLDs

Generic Manufacturers,
CROs and Regulatory Consultants

RLD demand is concentrated among organisations preparing regulatory submissions, running clinical or bioequivalence studies, or building dossiers for global market authorisation.

Generic Pharmaceutical Manufacturers

ANDA filings to the US FDA require bioequivalence demonstration against the listed RLD. UK abridged generic applications require a reference medicinal product, and other regulators set their own rules. RLDs are also used for in vitro dissolution profiling, BCS classification studies and as positive controls in formulation development.

Contract Research Organisations

CROs running bioequivalence and bioavailability studies on behalf of generic sponsors require single-batch RLD supply with full documentation. Protocol design typically specifies the comparator batch in advance, and batch-level traceability is recorded for each batch supplied.

Regulatory and Dossier Consultants

Consultancies preparing CTD modules, regulatory dossiers and submission packages need verified RLD provenance to support comparator product information, package insert reviews, and Module 3 quality data. Consultants should confirm what each regulator accepts.

The Euro Biom RLD Service

Verified provenance.
Single-batch sourcing. Documentation as available.

RLD work is unforgiving. The wrong batch, missing paperwork or an unverified source can derail a submission, so we source through the UK licensed supply chain and confirm batch number and expiry at quotation.

Documented Manufacturer Provenance

RLDs are sourced through the UK licensed supply chain: marketing authorisation holders, PLPI holders or licensed UK wholesalers. Provenance is documented from the UK licensed supplier through to delivery.

WDA(H) 59239 sourcing only

Single-Batch Sourcing for BE Studies

Bioequivalence study protocols typically require all RLD doses to come from a single manufacturer batch. We confirm batch availability at quotation and record batch number, manufacture date and expiry on each shipment.

Single-batch sourcing subject to availability

Supply Documentation

Supplies are accompanied by batch details and GDP records, and a Certificate of Pharmaceutical Product where available, with a manufacturer Certificate of Analysis confirmed at quotation stage where the manufacturer makes one available.

CoPP, batch records, transport logs

Cold Chain and GDP Compliance

RLDs requiring temperature-controlled storage, including refrigerated formulations and other temperature-sensitive UK-licensed medicines, are handled under UK Good Distribution Practice. Our contract storage site operates under its own GDP licence.

2-8°C supply

RLD Documentation

The UK-side documents
available for the product.

Missing documents can lead to a deficiency letter. Euro Biom provides the documents available for the product with each supply.

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Batch and Expiry Confirmation

Batch number and expiry date for every line, confirmed at quotation stage where available.

Certificate of Pharmaceutical Product (CoPP)

WHO-format CoPP issued by the MHRA to the marketing authorisation holder, passed on where available.

Batch Records and Manufacturer Traceability

Batch number and expiry confirmation for the stock supplied, with release records where available and GDP chain-of-custody records.

Package Insert and SmPC

UK Patient Information Leaflet and Summary of Product Characteristics as authorised by MHRA, supplied for comparator product information in dossier work.

Transport and Cold Chain Records

Data logger output from the carrier where relevant, supporting the temperature record for the shipment.

UK Export Documentation

Commercial invoice and packing list, plus certificates of free sale and other export documents where the issuer makes them available.

How It Works

From RLD Identification
to Documented Delivery

Our five-step process is built around the regulatory submission timelines and study protocols you work to.

Step 01

RLD Identification

Confirm the exact innovator brand, INN, strength and formulation.

Step 02

Sourcing Assessment

Identify UK marketing authorisation holders and licensed UK wholesalers, confirm batch availability, present sourcing options with indicative lead times.

Step 03

Verification and Reservation

Verify batch provenance, confirm required quantities for single-batch BE studies, and confirm batch number and expiry for protocol records, subject to availability.

Step 04

Documentation Pack

Compile the documents available for the product: batch records, package insert, SmPC, transport and export documentation, and the CoPP where the MA holder provides one, plus a manufacturer CoA where one is made available.

Step 05

Shipment and Delivery

Dispatch via specialist carriers, in temperature-controlled packaging where required. Export documentation for international consignments.

Where RLD Demand Is Highest

Therapeutic Areas We Supply

RLD requirements are most concentrated in therapeutic areas with active generic competition, complex formulation challenges or patent expiries.

Cardiovascular

High-volume RLD demand for ACE inhibitors, ARBs, statins, anticoagulants and antiarrhythmics with extensive generic pipelines.

CNS and Neurology

RLDs for SSRIs, SNRIs, antipsychotics, anticonvulsants and Parkinson's therapies, including modified-release formulations requiring complex BE designs.

Oncology

Innovator branded oncology RLDs for tyrosine kinase inhibitors, hormone therapies, cytotoxics and supportive care, often with restricted allocation.

Hormones and Endocrinology

Reference products for thyroid hormones and oral contraceptives.

Antibiotics and Antivirals

Reference products for fluoroquinolones, beta-lactams, antiretrovirals, hepatitis C therapies and antifungals.

Respiratory

Inhaled corticosteroids, LABA, LAMA combinations and dry powder inhaler innovator brands requiring rigorous in vitro and PK comparator work.

Diabetes and Metabolic

DPP-4 inhibitors, SGLT2 inhibitors, biguanides and combination products.

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Other Therapeutic Areas

RLD supply for UK-licensed medicines in other therapeutic areas including dermatology, gastroenterology, urology and ophthalmology. Submit your specific requirement for a sourcing assessment.

Ready to Source Your RLD?

Tell us the brand, INN, strength and quantity. We respond the same working day with sourcing options and batch availability. No commitment required at enquiry stage.

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Frequently Asked Questions

RLD Supply, Explained

Common questions from generic manufacturers, CROs and regulatory consultants.

What is a Reference Listed Drug (RLD)?

A Reference Listed Drug is the originator branded product against which a generic equivalent is benchmarked for bioequivalence. In the United States the RLD is identified in the FDA Orange Book. In the EU and UK the equivalent concept is the reference medicinal product, the innovator authorised under a full marketing authorisation.

Why do generic manufacturers need RLDs from the UK?

Generic manufacturers, CROs and regulatory consultants use UK-licensed reference products for UK abridged applications, bioequivalence studies, in vitro dissolution work and BCS classification. Each regulator decides which reference product it accepts.

Can you supply single-batch RLDs for BE studies?

Subject to availability. Bioequivalence protocols typically require a single batch of RLD to control batch-to-batch variability. We source from MHRA-authorised channels and record batch number and expiry for each shipment.

What documentation comes with an RLD supply?

RLD supplies are accompanied by batch details, GDP records, temperature records where applicable, package insert and SmPC, and the UK export documentation available for the product, with a Certificate of Pharmaceutical Product where required and a manufacturer Certificate of Analysis confirmed at quotation stage where the manufacturer makes one available.

How quickly can you source an RLD?

For commonly available innovator brands sourced through standard UK distribution, typical dispatch is within 24 to 72 hours of order confirmation, subject to availability. For restricted allocation products or rare reference standards, we provide a realistic lead time at enquiry. We respond to all enquiries the same working day.

Do you supply RLDs internationally?

Yes. We can export UK-licensed reference products to clinical research organisations and generic manufacturers, subject to the importing country's rules. Our MHRA WDA covers export, and we prepare the commercial invoice and packing list and pass on other UK export documents where the issuer makes them available.

What information do I need to provide for an RLD enquiry?

Brand name and INN of the innovator, strength and formulation, quantity required, single-batch requirement if applicable, intended use such as BE study or ANDA filing, destination country, and any urgency. The more detail you provide, the faster we can confirm sourcing.

Related Resources

Further reading for generic manufacturers, CROs and regulatory consultants.

Service

Named Patient Import Supply for Hospitals and Institutions

View service →

Service

Managed Access Programs: UK-Licensed Supply for Compassionate Use

View service →

Compliance

Our Regulatory Credentials and MHRA WDA Documentation

View compliance →

Guide