When a medicine cannot be sourced through normal UK supply channels, pharmacy procurement teams may need to look beyond the licensed UK market.

One potential route is an imported unlicensed medicine: a medicine that may be routinely licensed and supplied in another country but does not hold the relevant UK marketing authorisation.

This can be particularly relevant during medicine shortages, where the usual UK product is unavailable and suitable licensed alternatives cannot meet the patient's clinical need.

Importing an unlicensed medicine is, however, very different from simply buying stock overseas. There are specific regulatory requirements, supplier checks and local governance responsibilities that pharmacy teams need to understand.

This guide explains how the process works, what procurement teams should consider and what information Alcatia Pharma needs when investigating an international sourcing requirement.

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What is an imported unlicensed medicine?

A medicine is considered unlicensed in the UK if it does not have a marketing authorisation applicable to the UK for the product being supplied.

Under the Human Medicines Regulations 2012, unlicensed medicines can be supplied in certain circumstances to meet the special clinical needs of individual patients. They are often referred to as Specials.

An imported unlicensed medicine might therefore be a product that:

• contains the same active ingredient as a UK medicine;
• has the same strength and pharmaceutical form;
• is manufactured commercially;
• has a marketing authorisation in another country; but
• does not have the required UK marketing authorisation.

That distinction is important.

Unlicensed in the UK does not necessarily mean the medicine is unlicensed everywhere.

A medicine routinely supplied in another regulated market can still be considered an unlicensed medicine when imported for use in the UK.

Why are unlicensed medicines imported into the UK?

There are several circumstances in which an imported medicine may be considered.

For pharmacy procurement teams, one of the most important is a UK medicine shortage.

For example, the normal licensed product may be:

• temporarily unavailable;
• subject to allocation;
• discontinued;
• affected by manufacturing problems;
• unavailable in the required strength or presentation; or
• unable to meet a particular patient's clinical requirements.

An alternative product may sometimes be commercially available in another country even though UK stock cannot be obtained.

Unlicensed imports can therefore provide an additional supply route when the normal UK market cannot meet a legitimate clinical requirement.

However, the existence of overseas stock is not enough on its own to justify importing it.

What does "special clinical need" mean?

This is one of the most important principles for pharmacy procurement teams to understand.

The MHRA states that unlicensed medicines may be supplied where available licensed medicines cannot meet the needs of an individual patient, and that those needs must be clinical in nature and determined by the responsible prescriber.

An unlicensed import should therefore not be regarded simply as:

• a cheaper alternative;
• a more convenient purchasing route;
• another source of routine stock; or
• a substitute for an available licensed medicine without clinical justification.

In a shortage, the position may be different because the licensed product that would ordinarily meet the patient's need may genuinely be unavailable.

The clinical decision and justification remain the responsibility of the appropriate healthcare professionals and should sit within the organisation's governance procedures.

Who is allowed to import an unlicensed medicine?

A UK pharmacy procurement team would not normally respond to a shortage by independently purchasing medicines from an overseas wholesaler and arranging delivery into the UK.

The import itself must be undertaken through an appropriately licensed importer.

Current MHRA guidance distinguishes between imports according to the country from which the medicine is being imported. Depending on the source market, the importer requires either an appropriately authorised Wholesale Dealer's Licence (WDA(H)) or a Manufacturer's "Specials" Licence covering the relevant import activity.

This is one reason specialist medicine importers form an important part of the shortage supply chain.

The procurement team identifies the requirement. The specialist importer investigates potential sources and handles the appropriate import process.

Does the MHRA need to be notified?

Yes.

Before an unlicensed medicine is imported, the licensed importer must notify the MHRA of its intention to import the product. The notification includes information supporting the medicine's special clinical need together with evidence relating to appropriate manufacturing and distribution standards.

Only appropriately licensed importers can submit these notifications.

The MHRA can:

• raise no objection to the import;
• request further information;
• impose conditions; or
• object to the proposed import.

The process also specifically recognises imports intended to mitigate shortages of licensed UK medicines.

Does a "no objection" mean the MHRA has approved the medicine?

No.

This is an important distinction.

The MHRA notification process should not be interpreted as a UK marketing authorisation or an MHRA approval of the imported product.

NHS Specialist Pharmacy Service guidance makes clear that the MHRA does not undertake the same full assessment of the product's quality, safety and efficacy that would apply to a licensed medicine. The MHRA may not object to an import, but responsibility for assessing whether the product is suitable remains with the purchaser and prescriber.

That makes pharmacy quality assurance and procurement governance particularly important.

What should pharmacy procurement teams assess?

Buying an imported unlicensed medicine requires more information than placing a conventional wholesaler order.

NHS SPS advises that purchasing Specials can require evaluation of several potential options and should include defining the required product, identifying a suitable supplier, assessing quality and checking the medicine when it is received.

A practical procurement assessment should therefore consider the following areas.

1. Define exactly what product is required

Before approaching potential suppliers, establish a clear purchasing specification.

That may include:

• active ingredient;
• brand, where relevant;
• strength or concentration;
• pharmaceutical form;
• route of administration;
• pack size;
• quantity;
• excipients;
• release characteristics;
• storage conditions;
• minimum acceptable shelf life;
• labelling requirements; and
• required delivery date.

NHS SPS specifically recommends defining the characteristics that are essential and those that are merely desirable, because an overseas product may not match every characteristic of the usual UK presentation.

This is particularly important during shortages.

A procurement request for "aztreonam", for example, provides significantly less sourcing information than a request specifying the exact strength, form, quantity and required date.

2. Verify the importer

Procurement teams should establish that the supplier has the appropriate MHRA authorisation for the activity being undertaken.

NHS SPS recommends sourcing Specials from reputable suppliers with the correct MHRA licences and notes that relevant manufacturing and wholesale authorisations can be checked against MHRA registers.

This should form part of supplier due diligence rather than relying solely on a supplier's statement that it can obtain the product.

3. Understand where the medicine is licensed

For an imported commercial product, the supplier should be able to provide information including:

• the Marketing Authorisation Holder;
• the country in which the medicine is licensed; and
• the relevant marketing authorisation or equivalent licence number.

This helps the pharmacy team understand the regulatory status and origin of the product being offered.

The country from which a medicine is physically sourced and the country in which it holds a marketing authorisation are not necessarily the same, so both can matter when assessing the proposed supply chain.

4. Assess pharmaceutical quality

Imported unlicensed medicines require a local quality assessment.

NHS SPS advises purchasers to obtain sufficient information to establish that the medicine:

• is of appropriate pharmaceutical quality;
• meets the purchasing specification;
• is suitable for the intended patient; and
• is packaged and labelled in a way that minimises medication error.

The exact documentation required will depend on the medicine, dosage form, manufacturer and source country.

For some products this assessment may be relatively straightforward. Others, particularly sterile or complex medicines, may require substantially more information.

A specialist importer should be able to provide appropriate product and supply-chain information to support the receiving organisation's assessment.

5. Consider differences from the UK product

An overseas medicine should not automatically be assumed to be identical to its UK equivalent simply because the active ingredient and strength match.

Potential differences can include:

• excipients;
• concentration;
• administration device;
• vial or ampoule size;
• pack configuration;
• storage requirements;
• appearance;
• preparation instructions;
• licensed indications;
• product information; and
• labelling language.

These differences may be clinically or operationally significant.

For that reason, pharmacy assessment should be based on the actual imported product being supplied, not merely the generic molecule name.

6. Review labelling and packaging

Imported medicines may arrive in packaging intended for another country's healthcare system.

The primary and secondary packaging, patient information and instructions may therefore not be in English.

This creates additional medication-safety considerations.

NHS SPS specifically highlights packaging and labelling as areas that must be assessed when determining the suitability of an imported Special.

Local processes may therefore need to consider measures such as supplementary information, over-labelling or other risk controls where appropriate.

7. Check quantity and continuity of supply

International availability can be volatile during a shortage.

Finding stock today does not necessarily mean the same product will remain available next month.

There can also be restrictions on the quantities of an individual unlicensed medicine imported at one time, meaning specialist importers may hold comparatively limited stock.

Procurement teams should therefore consider:

Immediate requirement:
How many packs are needed now?

Expected duration:
Is this a one-off requirement or is continuing supply likely to be necessary?

Future demand:
Will additional patients require the product if the UK shortage continues?

Lead time:
How long will replenishment take from the overseas market?

For treatments likely to continue, supply continuity should form part of the procurement assessment rather than simply resolving the first order.

What does the unlicensed import process look like?

From the perspective of a pharmacy procurement team, a typical sourcing route might look like this:

1. A sourcing requirement is identified

The usual licensed product cannot be obtained or cannot meet the patient's clinical need.

2. Licensed alternatives are considered

The pharmacy and clinical team determine whether another licensed product can appropriately meet the requirement.

3. A specialist importer is contacted

The requirement is provided with sufficient detail to investigate international availability.

4. Potential overseas products are identified

The importer searches appropriate markets and obtains information on available products, manufacturers, quantities and lead times.

5. The pharmacy team reviews the proposed product

Clinical, procurement and quality teams assess whether the proposed medicine is suitable.

6. Regulatory requirements are completed

Where the supply proceeds as an unlicensed import, the licensed importer completes the relevant MHRA notification process.

7. The product is imported and supplied

Once the necessary requirements have been met, the medicine can enter the UK supply chain and be delivered to the customer.

The precise sequence can vary depending on the product and urgency.

How long does importing an unlicensed medicine take?

There is no single lead time.

It depends on factors including:

• medicine availability;
• source country;
• supplier lead time;
• documentation;
• MHRA requirements;
• freight arrangements;
• temperature control;
• customs;
• the quantity required; and
• whether the requirement is urgent.

The standard MHRA notification process provides for an assessment period of up to 28 days after acknowledgement, although the MHRA can expedite justified cases. Its current guidance states that life-threatening or immediately injurious clinical emergencies may, where appropriate, be assessed within two working days.

That does not mean every import takes 28 days. Nor does it mean an urgent medicine can necessarily be delivered within two days. Regulatory assessment is only one component of the overall sourcing and logistics process.

The earlier a procurement team identifies a potential supply problem, the more options an importer is likely to have.

What information should you give Alcatia?

A clear sourcing request allows us to investigate international availability much more effectively.

At minimum, provide:

Medicine or active ingredient
The product or molecule required.

Strength
For example, 1 g rather than simply the medicine name.

Pharmaceutical form
Tablet, capsule, vial, ampoule, oral solution, injection, pre-filled syringe or other form.

Quantity
The approximate number of packs, units or doses required.

Required-by date
When the medicine needs to reach your organisation.

Where available, it is also helpful to provide:

• preferred manufacturer or brand;
• current UK product;
• pack size;
• minimum shelf life;
• storage requirements;
• details of the relevant shortage;
• whether substitutions in presentation can be considered; and
• any other essential product requirements.

You do not need to identify an overseas manufacturer or determine the relevant import route before contacting us.

That investigation is part of the sourcing process.

What should a procurement team ask an unlicensed medicine supplier?

Before proceeding with a new imported medicine, useful questions include:

• What is the exact product being supplied?
• Who manufactures it?
• In which country is it licensed?
• What is its marketing authorisation number?
• From which country will it be imported?
• What is the available quantity?
• What shelf life will be supplied?
• What are the storage requirements?
• What language is used on the packaging and product information?
• What quality documentation can be provided?
• What is the estimated lead time?
• Can future supply be obtained if the shortage continues?

A reputable supplier should be prepared to provide the information necessary for an appropriate local assessment. NHS SPS advises that reluctance to provide quality information should be treated as a reason to consider an alternative supplier.

Unlicensed medicine procurement requires local governance

The supplier and importer are only part of the process.

Healthcare organisations remain responsible for their own governance around the prescribing, purchasing, receipt, storage and use of unlicensed medicines.

NHS SPS recommends a formal governance system covering areas including sourcing, quality assessment, receipt checking, storage, record keeping, staff responsibilities, incident escalation and pharmacovigilance. It also recommends a rigorous risk assessment before a new unlicensed medicine is used.

For procurement teams, that means sourcing should be coordinated with the appropriate pharmacy, clinical and quality colleagues rather than treated purely as a purchasing exercise.

Unlicensed imports during UK medicine shortages

During a shortage, speed matters, but so does precision.

A specialist importer may be able to identify overseas stock when conventional UK wholesalers cannot supply the medicine.

The most effective enquiries therefore tend to be the ones that answer four questions clearly:

What medicine do you need?
What exact presentation do you require?
How much do you need?
When do you need it?

From there, the sourcing team can investigate whether an appropriate international option exists.

Availability is never guaranteed, and an overseas product still needs to pass the relevant regulatory, clinical and local quality processes.

But where licensed UK supply cannot meet a genuine clinical requirement, imported unlicensed medicines can provide an important additional sourcing route.

Need help sourcing an unlicensed medicine?

Alcatia Pharma works with pharmacy procurement teams to investigate difficult-to-source medicines and potential international supply options.

You do not need to know which country has stock or exactly which regulatory route may apply.

Send us the requirement and we can begin investigating the available options.

Having difficulty sourcing a medicine?

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This article is intended for general information for healthcare procurement and medicines-supply professionals. It does not constitute clinical, legal or regulatory advice. The prescribing, procurement and use of unlicensed medicines should be undertaken by appropriately authorised professionals in accordance with current MHRA requirements, NHS guidance and local governance procedures.