UK Pharmaceutical
Import Documentation
CPP, GMP, Free Sale, Batch Release, Legalisation and Permits, Explained
Euro Biom is an MHRA WDA-licensed UK wholesale exporter. We supply only UK-licensed medicines, and we provide the documentation set that hospitals, ministries of health, NGOs and distributors need to clear those products into their market. This page explains each document, what it proves and how we support it.
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What documents are needed to import UK-licensed medicines?
Most destination regulators require the same core documentation set when a UK-licensed medicine is imported. It falls into three groups. Product and manufacturer evidence: a Certificate of Pharmaceutical Product (CPP) in WHO format, Good Manufacturing Practice (GMP) evidence for the manufacturer, and, where the destination asks for it, a Certificate of Free Sale. Batch evidence: the batch release certificate and Certificate of Analysis (CoA) for the exact batch supplied. Shipment and trade evidence: a commercial invoice, a packing list, and GDP chain-of-custody plus temperature logger records for temperature-controlled goods.
On top of that core set, many countries require a destination import permit or a named-patient or institutional authorisation, issued by the local regulator or health ministry. Some markets, the GCC in particular, also require documents to be legalised through an apostille and then embassy or consulate attestation. The exact combination depends on your destination country and the product. Euro Biom supplies UK-licensed medicines and provides the UK-side documentation those imports depend on. We do not act as a regulatory consultancy and we do not give legal advice, we provide the certificates and records that accompany the goods.
Scope note. Euro Biom trades only in UK-licensed, MHRA-authorised medicines. Named-patient supply, as described here, refers to the buyer's destination-country import route for UK-licensed products where they are not separately registered locally. Destination import permits, registration and legalisation requirements are set by the importing country and its appointed agents.
and Who Issues It.
A clear breakdown of each document in the import chain for UK-licensed medicines, written for hospital pharmacists, procurement teams and registration leads.
Certificate of Pharmaceutical Product (CPP)
What it is. A certificate in the World Health Organization (WHO) format confirming a medicine's marketing authorisation status in the exporting country and describing the product, its composition and its licence holder.
What it proves to the destination regulator. That the product is genuinely authorised in the UK and is supplied under a valid UK marketing authorisation. The CPP is the single most commonly requested document for medicine registration and import worldwide.
Who issues it. The MHRA issues the CPP on application by the UK Marketing Authorisation Holder.
GMP Certificate (Good Manufacturing Practice)
What it is. A certificate issued after a regulator inspects a manufacturing site, confirming the site makes medicines to recognised quality standards.
What it proves to the destination regulator. That the manufacturer of the imported product operates to a recognised GMP standard. Destination regulators frequently require GMP evidence for the manufacturer before allowing import or registration.
Who issues it. For UK manufacturing sites, the MHRA, following GMP inspection.
Certificate of Free Sale
What it is. A document confirming that a product is freely sold in its country of origin and may be lawfully exported.
What it proves to the destination regulator. That the product is legally on the market in the UK and not subject to a sales restriction. Some regulators accept a CPP in its place, others request both.
Who issues it. In the UK this is issued by the MHRA or relevant competent authority depending on the product category.
Batch Release Certificate and Certificate of Analysis (CoA)
What it is. The Certificate of Analysis lists the laboratory tests performed on a specific manufactured batch and the results against specification. The batch release certificate confirms that batch was formally released for supply.
What it proves to the destination regulator. That the exact stock being imported was tested, met specification and was released by the manufacturer. These documents are batch-specific, so they tie directly to the units you receive.
Who issues it. The product manufacturer, against the batch.
Document Legalisation, Apostille and Attestation
What it is. The process of officially authenticating documents so a foreign authority will accept them. In the UK this typically begins with an apostille from the Foreign, Commonwealth and Development Office (FCDO), followed where required by attestation at the destination country's embassy or consulate in London.
What it proves to the destination regulator. That the UK-issued documents are genuine and recognised for official use in the destination country. GCC markets commonly require this two-step apostille then embassy legalisation chain on key documents.
Who issues it. The FCDO for apostille, then the relevant embassy or consulate for attestation. Requirements are set by the destination country.
Import Permit and Named-Patient Authorisation
What it is. An authorisation from the destination country's medicines regulator or health ministry permitting a specific import. For UK-licensed products that are not separately registered in the destination, this may take the form of a named-patient or institutional import authorisation.
What it proves to the destination regulator. That the importing institution is authorised to bring the product in for the stated purpose. This is a destination-side document, issued in the importing country.
Who issues it. The destination country's regulator or health ministry. The buyer or their local agent usually applies.
Cold-Chain and GDP Chain-of-Custody Records
What it is. The records that travel with a temperature-controlled shipment: GDP chain-of-custody documentation, packing and configuration details, and continuous temperature logger data covering transit.
What it proves to the destination regulator. That the cold chain was maintained from dispatch to delivery. Customs and receiving pharmacies check these records before accepting temperature-sensitive stock.
Who issues it. The supplier and its specialist logistics chain, against the shipment.
Commercial Invoice and Packing List
What it is. The trade documents describing the goods, values, quantities and pack configuration for the consignment.
What it proves to the destination regulator. They give customs and the importer the commercial and logistical detail needed to clear and reconcile the shipment against the import permit and product documentation.
Who issues it. The supplier, against each shipment.
Import Document Set.
A summary table of the documents most imports require, who issues each and which Euro Biom provides or supports as the UK-licensed supplier. Exact requirements depend on your destination country.
| Document | What it proves | Who issues it | Euro Biom role |
|---|---|---|---|
| Certificate of Pharmaceutical Product (CPP) | UK marketing authorisation status, WHO format | MHRA | Helps buyer obtain the correct CPP |
| GMP Certificate | Manufacturer meets Good Manufacturing Practice | MHRA (UK sites) | Provides manufacturer GMP evidence |
| Certificate of Free Sale | Product freely sold and exportable from UK | MHRA / authority | Supports where destination requires it |
| Batch Release Certificate | Batch formally released for supply | Manufacturer | Provided with the dispatched batch |
| Certificate of Analysis (CoA) | Batch tested and met specification | Manufacturer | Provided with the dispatched batch |
| Commercial Invoice and Packing List | Goods, values, quantities, pack configuration | Supplier | Prepared for every export |
| GDP Chain-of-Custody Records | Compliant handling from dispatch to delivery | Supplier | Included with the shipment |
| Temperature Logger Records | Cold chain maintained in transit | Supplier / logistics | Included with cold-chain shipments |
| Document Legalisation / Apostille | UK documents recognised abroad | FCDO, then embassy | Prepares documents in required format |
| Import Permit / Named-Patient Authorisation | Institution authorised to import | Destination regulator | Supplies UK-side evidence for the application |
This table is a general reference for UK-licensed medicines. It is not legal or regulatory advice. Your destination country's regulator sets the definitive requirements, and a local agent often manages the destination-side permit and registration steps.
UK-side documents, prepared
by an MHRA WDA holder.
Euro Biom is the UK-licensed supplier in your import chain. We provide the certificates and records that originate in the UK, so your import permit and registration files are complete.
Product and Manufacturer Evidence
We help buyers obtain the CPP in WHO format, provide GMP evidence for the manufacturer of the UK-licensed products supplied, and support a Certificate of Free Sale where the destination requires one.
Batch-Level Documentation
Every dispatch is accompanied by the batch release certificate and Certificate of Analysis for the exact batch supplied, matched to the stock you receive, under our GDP Quality Management System.
GDP and Cold-Chain Records
For temperature-controlled products, shipments carry GDP chain-of-custody documentation and continuous temperature logger data, handled under our WDA(H) 59239 cold-chain scope.
Trade and Export Paperwork
We prepare the commercial invoice and packing list for every export and supply documents in the formats that apostille and embassy legalisation require, so buyers can complete the destination-side steps.
Step by Step.
How the documentation comes together on a typical UK-licensed medicine export. The destination-side steps are managed by the buyer or their local agent.
Need the Right Documents for Your Import?
Tell us the product and destination country. We respond the same working day with the UK-side documentation set and how we provide it. Every supply runs under WDA(H) 59239 and full GDP documentation.
The questions hospital pharmacists, ministry procurement teams and registration leads most often ask about importing UK-licensed medicines.
Further reading for procurement teams, registration leads and hospital pharmacists importing UK-licensed medicines.
Longer reads on UK licensing, GDP compliance and importing into specific markets.