Yes.

A UK pharmaceutical wholesaler can source medicines from overseas, but it cannot simply purchase stock internationally and bring it into the UK in the same way as an ordinary commercial product.

Medicines sit within a tightly controlled supply chain. The wholesaler's MHRA authorisation, the licensing status of the medicine, the country it is being sourced from and the intended use of the product all determine which import route can be used.

For pharmacy procurement teams dealing with a shortage or difficult-to-source medicine, this distinction matters.

An overseas market may have stock when UK wholesalers do not. But finding stock and being legally able to supply that stock into the UK are two different things.

This guide explains how overseas sourcing works and when a specialist pharmaceutical wholesaler such as Alcatia Pharma may be able to help.

Having difficulty sourcing a medicine?

Can any pharmaceutical wholesaler import medicines?

No.

A company involved in wholesale distribution of human medicines in the UK will generally require a Wholesale Dealer's Authorisation for human medicines, commonly referred to as a WDA(H), and the activities it carries out must fall within the scope of that authorisation. MHRA guidance specifically identifies importing medicinal products from approved countries for import into Great Britain for wholesale distribution as an activity requiring a WDA(H).

The important point is that having a wholesale licence does not automatically authorise every type of international sourcing activity.

The licence specifies matters such as:

• the categories of medicines that may be handled;
• whether medicines with or without UK authorisation may be handled;
• the wholesale activities permitted;
• whether products may be imported from countries on the approved list; and
• any categories of medicines requiring additional controls.

The exact authorisation therefore needs to be checked rather than assuming that every licensed wholesaler can perform the same activities.

What determines whether an overseas medicine can be supplied?

There are three fundamental questions.

1. Is the medicine licensed for the UK market?

The first distinction is whether the specific medicine being imported has an appropriate UK marketing authorisation.

If it does, the import follows the regulatory route for licensed medicines.

If it does not, it may need to be treated as an unlicensed medicine, with additional requirements before it can be imported and supplied.

2. Where is the medicine coming from?

The source country matters.

MHRA rules distinguish between medicines imported from a country on the UK's Approved Country for Import list and medicines arriving from countries outside that framework. The licences and controls required can differ accordingly.

3. Why is the medicine being imported?

For an unlicensed medicine intended for UK patients, there must be a legitimate special clinical need.

Unlicensed medicines cannot simply be imported because overseas stock is cheaper or more commercially attractive. The MHRA requires evidence of the special clinical need when an importer submits its notification of intent to import an unlicensed medicine.

How does importing a licensed medicine work?

If an overseas medicine has the appropriate UK marketing authorisation, it may potentially be imported through a licensed supply route.

The MHRA states that importing licensed human medicines can require one or more of:

• a Wholesale Dealer's Authorisation, WDA(H);
• a Manufacturer's Licence; and
• the relevant Marketing Authorisation.

For a Great Britain wholesaler importing appropriately certified medicines from an approved country, a Responsible Person for Import, or RPi, may also be required.

The RPi is responsible for ensuring that appropriate Qualified Person certification has taken place before relevant medicines imported from approved countries are placed into the Great Britain supply chain.

This means an overseas supplier having stock available is not, by itself, sufficient.

The medicine and the supply route must meet the applicable UK regulatory requirements.

What if the overseas medicine is not licensed in the UK?

This is particularly relevant during medicine shortages.

Imagine that a hospital ordinarily purchases a licensed UK medicine but the product becomes unavailable nationally.

The same active ingredient and strength may still be routinely marketed in:

• Germany;
• France;
• Spain;
• another European market; or
• another country internationally.

That overseas product may be fully licensed in its own market but still be unlicensed for supply in the UK if it does not have the relevant UK authorisation.

The medicine may potentially be imported to meet a special clinical need, but it must follow the UK's regulatory route for unlicensed medicines.

Can a wholesaler import an unlicensed medicine?

Yes, where the appropriate conditions are satisfied.

The exact licence required depends on the source country.

The MHRA states that an unlicensed medicine imported from a country on the Approved Country for Import list requires an appropriately scoped WDA(H).

Where the unlicensed medicine is being imported from a country outside the approved-country framework, a Manufacturer's "Specials" Licence is required instead.

In addition, the importer must notify the MHRA before the unlicensed medicine is imported.

The notification includes:

• the relevant MHRA notification form;
• evidence of compliance with appropriate Good Manufacturing and Good Distribution Practice; and
• evidence supporting the special clinical need for the medicine.

So while overseas sourcing is possible, it is a regulated pharmaceutical import process rather than conventional international purchasing.

Does a shortage justify importing an unlicensed medicine?

A medicine shortage can create circumstances in which unlicensed supply becomes relevant, but it does not automatically remove the requirement for appropriate clinical justification.

The MHRA's framework for unlicensed medicines exists to meet special clinical needs where an appropriate authorised medicine cannot meet that need.

In practical terms, pharmacy teams may first consider whether the requirement can be met through:

1. remaining licensed UK stock;
2. another licensed strength or presentation;
3. another clinically appropriate licensed product; or
4. another authorised supply route.

Where those options cannot meet the clinical requirement, an imported unlicensed product may become a potential solution.

Why would a UK wholesaler search overseas during a shortage?

Medicine availability is not uniform across countries.

A manufacturing issue, market withdrawal, allocation or increase in demand may significantly affect UK availability while stock remains commercially available elsewhere.

A specialist sourcing wholesaler can therefore investigate international markets to identify whether an appropriate product exists.

That investigation may include:

• identifying licensed manufacturers internationally;
• checking wholesaler availability;
• establishing available quantities;
• confirming the exact presentation;
• reviewing pack configuration;
• establishing source-country licensing;
• obtaining shelf-life information;
• checking storage requirements;
• determining likely lead times; and
• establishing which UK regulatory route would apply.

This allows a pharmacy procurement team to move from:

"Our normal supplier cannot obtain it"

to:

"These are the alternative supply options available for our team to assess."

Finding overseas stock is only part of the process

This is one of the biggest differences between pharmaceutical sourcing and ordinary international procurement.

A supplier might locate 500 packs of the required medicine in another country tomorrow.

That does not necessarily mean those 500 packs can immediately be purchased and delivered to a UK hospital.

The proposed supply still needs to satisfy requirements relating to:

• the regulatory status of the product;
• supplier qualification;
• importer authorisation;
• pharmaceutical quality;
• Good Distribution Practice;
• transport conditions;
• product traceability;
• storage;
• documentation; and
• where applicable, MHRA notification.

Good Distribution Practice requires medicines to be obtained through the licensed supply chain and stored, transported and handled under conditions appropriate to the marketing authorisation or product specification.

Can medicines be sourced from anywhere in the world?

Potentially, but not through the same regulatory route.

The further a proposed supply sits outside the standard UK-authorised supply chain, the more important it becomes to establish the appropriate import route before committing to the purchase.

For Great Britain, MHRA guidance distinguishes between imports from approved countries for import and imports from other countries. Licensed medicines coming from countries outside the approved framework can require a Manufacturer's Licence rather than simply a WDA(H), while the same distinction also affects unlicensed imports.

A specialist wholesaler may therefore be able to source a medicine internationally while the actual importation is undertaken under a different licence or through another appropriately authorised organisation.

For procurement teams, the important question is not simply:

"Which country has the medicine?"

It is:

"Can an appropriate, compliant supply route be established from that country into the UK?"

What should a pharmacy procurement team provide?

International searches are far more effective when the requirement is precise.

If you ask a sourcing partner to find "amoxicillin", there may be hundreds of products internationally that technically match that description.

Instead, provide as much of the following information as possible.

Medicine or molecule

The exact active pharmaceutical ingredient or product name.

Strength

For example:

1 g

rather than simply the molecule.

Pharmaceutical form

For example:

• tablet;
• capsule;
• oral solution;
• powder for solution for injection;
• vial;
• ampoule;
• pre-filled syringe.

Quantity

State the number of packs, units or doses required.

Required-by date

International sourcing may involve additional regulatory and logistical steps, so this is particularly important.

Current UK product

Where possible, provide the manufacturer, brand, pack size or product details normally purchased.

Minimum shelf life

If your organisation has a minimum acceptable shelf life, include it at the beginning of the search.

Other essential requirements

For example:

• cold-chain handling;
• specific concentration;
• pack configuration;
• manufacturer restrictions;
• formulation requirements; or
• known excipient considerations.

Do you need to know which country to source from?

No.

You also do not need to identify an overseas manufacturer before making an enquiry.

The useful starting point is the clinical and procurement requirement, not the proposed solution.

Tell the sourcing team:

What you need.
How much you need.
When you need it.

The sourcing exercise can then establish where appropriate stock may exist and which supply routes might be viable.

How can pharmacy teams check whether a wholesaler is authorised?

The MHRA publishes its wholesale distribution authorisations through its public medicines licensing database.

Procurement teams can therefore check whether a company holds a current WDA(H) and review the scope of that authorisation.

This is useful when choosing a specialist sourcing partner because the public authorisation shows considerably more than simply whether the company describes itself as a pharmaceutical wholesaler.

It can show the categories of medicines and activities for which that wholesaler is authorised.

What is Alcatia Pharma authorised to do?

Alcatia Pharma Limited holds MHRA Wholesale Distribution Authorisation UK WDA(H) 59772. The current authorisation includes medicines with UK authorisation and medicines without UK authorisation intended for the UK market.

Its authorised wholesale operations include:

• procurement;
• supply;
• export; and
• products imported from countries on the approved list.

The authorisation also includes prescription-only medicines and cold-chain products requiring low-temperature handling.

Alcatia's site also holds a current MHRA Certificate of GDP Compliance, following an MHRA inspection of its wholesale distribution activities.

This means Alcatia can do more than simply search an international database for a medicine.

We can investigate overseas availability within a regulated pharmaceutical sourcing framework and determine whether a viable supply route can be established for the requirement.

What happens when Alcatia receives a sourcing request?

The first step is to establish exactly what your team requires.

From there, the sourcing process can investigate:

UK availability

Can the requirement still be fulfilled through an authorised licensed UK supply route?

International availability

Is an appropriate medicine available through overseas pharmaceutical suppliers?

Product suitability

What exact manufacturer, strength, form, pack and shelf life are being offered?

Regulatory route

Is the product licensed for the UK market, or would it need to be considered as an unlicensed medicine?

Quantity

Can sufficient stock be obtained to meet the immediate requirement?

Lead time

Can the product realistically reach your organisation when it is needed?

The result may be that an appropriate overseas option exists.

It may also be that the product cannot be sourced safely, legally or quickly enough.

A sourcing enquiry is therefore an investigation of the available options rather than a guarantee of supply.

Can a UK pharmaceutical wholesaler source medicines from overseas?

Yes, but only through an appropriate regulated supply route.

An overseas sourcing strategy requires more than finding a seller willing to ship the product.

The wholesaler needs to consider:

Is the medicine licensed or unlicensed in the UK?

Is the source country within the applicable approved-country framework?

Does the wholesaler's authorisation cover the required activity?

Does another pharmaceutical licence apply?

Can the supply chain meet GDP and quality requirements?

If the product is unlicensed, is there a valid special clinical need and has the appropriate MHRA process been followed?

When those questions can be answered appropriately, overseas sourcing can provide pharmacy teams with an important additional option when conventional UK supply routes fail.

Having difficulty sourcing a medicine?

If your normal UK supply route cannot fulfil a requirement, Alcatia Pharma can investigate whether alternative UK or international supply options are available.

You do not need to know where the medicine can be found.

Tell us:

Medicine
Strength
Form
Quantity
Required-by date

Our sourcing team can investigate the available routes from there.

Need help sourcing something?

This article provides general information for healthcare procurement and pharmaceutical supply professionals. It does not constitute legal, regulatory, clinical or prescribing advice. Importation and supply of medicinal products should be undertaken by appropriately authorised organisations in accordance with current MHRA requirements, the Human Medicines Regulations, applicable licence conditions and local governance procedures.