Alcatia Medicine Supply & Shortage Intelligence

Aztreonam Shortage: Sourcing Unlicensed 1g and 2g Supply in the UK

Alcatia — Mon, 17 Aug 2026 12:51:30 GMT

UK pharmacy procurement teams sourcing aztreonam 1g and 2g powder for solution for injection have been affected by a national supply shortage.

On 11 June 2026, the Department of Health and Social Care issued Medicine Supply Notification MSN/2026/025, classifying the shortage as Tier 2, medium impact. At the time of the notification, aztreonam 2g vials were out of stock and aztreonam 1g vials were expected to be out of stock from the end of June. Resupply dates had not been confirmed.

The notification also confirmed that unlicensed aztreonam 1g and 2g products had been sourced by specialist importers, providing an additional procurement route where licensed alternatives are not appropriate.

Alcatia Pharma is specifically listed in the national Medicine Supply Notification as one of the specialist importers that confirmed it could source unlicensed aztreonam in both 1g and 2g strengths.

If your organisation is currently experiencing difficulty sourcing aztreonam, Alcatia can investigate available unlicensed supply.

What is the current UK aztreonam supply issue?

Medicine Supply Notification MSN/2026/025 covers:

Aztreonam 1g powder for solution for injection vials
Aztreonam 2g powder for solution for injection vials

When the notification was issued on 11 June 2026:

2g vials were already out of stock
1g vials were expected to be out of stock from the end of June
resupply dates for both strengths were to be confirmed
alternative antimicrobials remained available
unlicensed products had been sourced to support demand.

Because supply positions can change, NHS organisations should check the latest entry in the Medicines Supply Tool alongside any sourcing enquiry. Community Pharmacy England notes that changes to resupply dates and Medicine Supply Notification entries are published through that tool.

What should pharmacy teams do during the aztreonam shortage?

The national notification advises NHS provider Trust pharmacy procurement teams and clinical teams to work together to review existing holdings of aztreonam 1g and 2g, including stock held at ward level.

Where available stock is insufficient, the guidance states that clinicians should:

Consider an appropriate alternative antimicrobial, referring to relevant clinical recommendations.
Consider an unlicensed aztreonam product only where licensed alternatives are not appropriate.
Work with pharmacy teams to place orders within appropriate timescales because lead times for imported products may vary.
Seek microbiology advice where the available options are not considered appropriate.

This distinction is important.

An unlicensed import is not simply another wholesaler option to be substituted automatically when licensed stock disappears. The clinical requirement and the suitability of available licensed alternatives must be considered first.

Can unlicensed aztreonam be sourced during the shortage?

Yes, subject to availability and the relevant clinical, regulatory and local governance requirements.

The national notification identifies a number of specialist importers that had confirmed they could source unlicensed aztreonam 1g and 2g powder for solution for injection vials.

The list includes:

Alium
Alcatia Pharma
Chemys
Clinigen Group
Durbin
Kent Pharma
Mawdsleys
Orifarm UK
Qmed Pharma
Tanner Pharma
Target Healthcare.

The notification also makes clear that this is not necessarily an exhaustive list of suppliers.

For procurement teams, the relevant point is that international unlicensed supply has been identified as a recognised mitigation for this specific shortage, rather than being a theoretical sourcing route.

What does "unlicensed aztreonam" mean?

An imported product can be licensed and routinely marketed in another country while still being classed as unlicensed in the UK.

The MHRA's framework for unlicensed medicinal products allows medicines to be specially manufactured or imported in defined circumstances to meet the needs of individual patients. These products are commonly referred to as Specials.

During the aztreonam shortage, a specialist importer may therefore identify a commercially manufactured aztreonam product from another market and arrange its import through the appropriate UK regulatory route.

That does not make the imported product equivalent to a UK-licensed medicine from a regulatory perspective.

Does the MHRA assess imported aztreonam centrally?

Pharmacy teams need to understand an important distinction.

The aztreonam Medicine Supply Notification states that unlicensed imports do not undergo a central quality assessment or suitability evaluation. Any imported product must therefore be locally assessed in accordance with the organisation's unlicensed medicines procedures.

The decision to prescribe or use an unlicensed medicine must also take account of relevant professional guidance and NHS Trust or local governance requirements.

This means the procurement process should not simply be:

Aztreonam unavailable → overseas stock found → order placed.

Instead, procurement, pharmacy quality and clinical teams need sufficient information about the proposed imported product to assess whether it is suitable.

What information should procurement teams request?

When Alcatia identifies a potential source of unlicensed aztreonam, the purchasing organisation may need information about the specific product being offered.

Depending on the source, this can include:

strength
pharmaceutical form
manufacturer
source country
country of marketing authorisation
pack size
available quantity
batch information
expiry date or remaining shelf life
storage conditions
packaging
language of product information
indicative lead time
supporting product documentation.

These details allow the receiving pharmacy team to assess the actual imported product, rather than assuming that every international aztreonam presentation is identical to the familiar UK product.

Why can imported products differ?

Matching the molecule and strength does not necessarily mean two medicines are identical in every respect.

An international aztreonam product could potentially differ in areas such as:

pack configuration
manufacturer
vial presentation
labelling
language
product information
storage requirements
preparation instructions
excipients.

The significance of any differences needs to be assessed by the appropriate pharmacy and clinical professionals.

This is one reason it helps to begin the sourcing process early. The procurement team needs enough time not only to locate stock, but also to evaluate the product being offered.

What does Alcatia need to investigate aztreonam supply?

For an initial sourcing enquiry, the most useful information is straightforward.

Strength

Specify whether you require:

Aztreonam 1g powder for solution for injection

Aztreonam 2g powder for solution for injection

If you require both strengths, provide the requirement for each separately.

Quantity

Tell us how many vials or packs you require.

International availability may be limited and can change quickly, so an approximate quantity is considerably more useful than simply asking whether aztreonam is available.

Required-by date

Tell us when the stock needs to arrive.

Lead times can vary between products and source markets, and the national shortage notification specifically warns that lead times for unlicensed products may vary.

Organisation

Provide the name of the NHS Trust, hospital, pharmacy, wholesaler or other healthcare organisation making the request.

Additional requirements

It is helpful to include any specific requirements around:

minimum shelf life
pack size
storage
manufacturer
previous product supplied
documentation
delivery location.

You do not need to identify an overseas supplier yourself.

Alcatia can investigate available international supply based on the requirement you provide.

How quickly can unlicensed aztreonam be sourced?

There is no universal lead time.

The time required can depend on:

availability in the source market
quantity required
location of the stock
supplier processing times
regulatory requirements
documentation
transport arrangements
customs and import processes
local product assessment.

The June Medicine Supply Notification specifically advises prescribers to work with local pharmacy teams to ensure orders are placed within appropriate timescales because lead times may vary.

For this reason, procurement teams should ideally begin investigating unlicensed supply before remaining local stock reaches a critical level, where the future requirement can reasonably be anticipated.

Should we order unlicensed aztreonam if we still have some licensed stock?

That is a decision for the relevant procurement, pharmacy and clinical teams.

The national guidance first asks Trusts to review the total stock they already hold, including ward holdings, and to consider appropriate licensed alternatives. Unlicensed products should be considered where licensed alternatives are not appropriate.

However, investigating potential availability does not require an organisation to commit immediately to an order.

Where stock is declining and replenishment is uncertain, an early sourcing enquiry can help establish:

whether unlicensed supply can currently be found
what quantities may be available
expected lead time
the precise product being offered
what documentation is available.

That information can then support the organisation's procurement planning.

Why was Alcatia Pharma named in the supply notification?

The national notification includes a section specifically addressing the ordering and prescribing of unlicensed imports.

It states that the listed specialist importers had confirmed they could source unlicensed aztreonam 1g and 2g powder for solution for injection vials.

Alcatia Pharma is one of the companies named.

For pharmacy procurement teams, this provides a useful distinction from a generic claim that a wholesaler may be able to source a medicine.

Alcatia's ability to investigate unlicensed aztreonam supply is explicitly referenced within the official national shortage notification.

It does not mean that stock is guaranteed to be available indefinitely. International availability can change as other organisations respond to the same shortage.

That makes it important to provide Alcatia with a specific quantity and required-by date when making an enquiry.

What happens when you send Alcatia an aztreonam sourcing request?

Once we know your requirement, our sourcing team can investigate the available supply options.

A useful request might look like:

Medicine: Aztreonam
Strength: 2g
Form: Powder for solution for injection vial
Quantity: 200 vials
Required by: 21 August
Organisation: [Your organisation]
Additional requirement: Minimum six months' shelf life

We can then establish whether a suitable source can be identified and provide the relevant information for your procurement team to assess.

Submitting a request is not confirmation that stock is available and does not commit your organisation to purchasing it.

It gives us the information required to conduct a meaningful supply search.

Need aztreonam 1g or 2g?

If your organisation is affected by the UK aztreonam shortage, Alcatia Pharma can investigate potential unlicensed supply.

Alcatia Pharma is named in Medicine Supply Notification MSN/2026/025 as a specialist importer that confirmed it could source unlicensed aztreonam 1g and 2g powder for solution for injection vials.

Tell us:

Which strength you need
How much you need
When you need it

Having difficulty sourcing aztreonam?

Our team will investigate available supply options and provide the relevant product information for your pharmacy procurement team to assess.

Supply information can change rapidly. Pharmacy teams should confirm the latest national shortage position through the Medicines Supply Tool and applicable NHS guidance. This article is intended for general information for healthcare procurement and medicines-supply professionals and does not constitute clinical, prescribing or regulatory advice. Decisions concerning the procurement, prescribing and use of unlicensed medicines should be made by appropriately authorised professionals in accordance with current MHRA requirements and local governance procedures.

Medicine Shortage Procurement: Frequently Asked Questions

Alcatia — Thu, 13 Aug 2026 10:46:48 GMT

Medicine shortages can turn a routine procurement requirement into a complex supply problem very quickly.

A product that was previously available through normal UK wholesale channels may become allocated, delayed or unavailable altogether. Pharmacy teams then need to establish what stock remains, whether alternative products are appropriate and whether another supply route can be identified.

The appropriate response varies by medicine, patient requirement and local governance. UK shortage management may involve remaining licensed stock, alternative presentations, clinically appropriate alternatives, mutual aid or, in some circumstances, an imported unlicensed medicine. DHSC and NHS England work with manufacturers, wholesalers and clinical partners to assess reported shortages and issue professional guidance through mechanisms including Medicine Supply Notifications and the NHS Medicines Supply Tool.

Below are answers to some of the most common procurement questions Alcatia Pharma encounters.

Currently struggling to source a medicine?

1. What counts as a medicine shortage?

A medicine shortage occurs when available supply cannot adequately meet demand within the healthcare system.

There can be several causes, including manufacturing disruption, unexpected demand, discontinuation, problems obtaining ingredients or packaging, regulatory issues and disruption elsewhere in the pharmaceutical supply chain.

Manufacturers are legally required to notify the Department of Health and Social Care of qualifying shortages and discontinuations. DHSC and NHS England then assess reported issues and determine what action may be required.

For an individual procurement team, however, the practical problem often appears much earlier:

the medicine you normally order is no longer available when you need it.

2. Where should pharmacy teams check for official shortage information?

For NHS professionals, national information may be communicated through:

Medicine Supply Notifications;
the NHS Medicines Supply Tool hosted by Specialist Pharmacy Service; and
Serious Shortage Protocols where one has been issued.

A procurement problem does not necessarily have to appear on a national shortage notice before you begin investigating alternative supply.

Local wholesaler availability, allocations and emerging supply disruption can all create difficulties before a formal national response is required.

3. What should we do first when a medicine becomes unavailable?

Start by defining the exact requirement.

Before searching for alternatives, establish:

medicine or active ingredient;
strength;
pharmaceutical form;
manufacturer or brand, if essential;
pack size;
quantity required;
minimum acceptable shelf life;
storage requirements; and
required delivery date.

This prevents procurement teams and suppliers from spending time investigating products that are technically similar but unsuitable for the actual clinical requirement.

The next step is to establish which available supply routes can realistically meet that specification.

4. Does our usual wholesaler being out of stock mean the medicine is unavailable nationally?

No.

Availability can vary between suppliers and different parts of the pharmaceutical supply chain.

A product may be:

unavailable from one wholesaler;
subject to allocation;
available only in limited quantities;
available through another authorised UK route; or
unavailable as a licensed UK product while stock exists internationally.

A shortage investigation should therefore distinguish between “our normal supplier cannot fulfil the order” and “no viable supply route currently exists.”

5. What options should procurement teams consider during a shortage?

Depending on the medicine and clinical circumstances, potential routes can include:

Remaining licensed UK stock.
An alternative authorised UK supplier.
Another pack size, strength or presentation.
Another clinically appropriate licensed medicine.
Mutual aid between NHS organisations.
A UK-manufactured unlicensed medicine.
An imported unlicensed medicine.

The appropriate clinical option must be determined by the relevant pharmacy and prescribing professionals.

For unlicensed medicines specifically, NHS SPS states that they should only be used where the patient's special clinical need cannot be met by an available licensed medicine.

6. Can another hospital supply us with stock?

Potentially.

NHS hospital pharmacies can use mutual aid in exceptional circumstances when standard supply routes cannot deliver quickly enough. This may include national shortages, sudden increases in demand or urgent patient requirements.

SPS advises that mutual aid should not replace the normal pharmaceutical supply chain and should generally only be requested once other supply options have been explored.

It can nevertheless provide an important short-term route for urgent requirements.

7. Can we source the medicine from overseas?

Potentially, yes.

Medicines may be available internationally even when the usual UK product cannot be obtained.

However, overseas sourcing is regulated pharmaceutical procurement. The product's UK licensing status, country of origin and proposed import route determine what authorisation is required.

For an unlicensed medicine, the MHRA requires an appropriate importer licence and notification of the intended import before the medicine is brought into the UK.

The relevant question is therefore not simply:

“Does another country have stock?”

It is:

“Can an appropriate product and compliant supply route into the UK be established?”

8. What is an unlicensed medicine?

An unlicensed medicine is a medicine that does not hold the relevant UK marketing authorisation.

That does not necessarily mean that it is unlicensed everywhere.

An imported product may be commercially manufactured and licensed in another country but still be considered unlicensed when supplied in the UK.

MHRA guidance permits the supply of unlicensed medicines in defined circumstances where there is a special clinical need that cannot be met by an available licensed medicine.

9. When can an unlicensed medicine be considered?

The key principle is special clinical need.

MHRA guidance states that the needs must be clinical in nature and determined by the prescriber responsible for the patient's care. Regulation 167 of the Human Medicines Regulations allows unlicensed medicines to be supplied when no available licensed medicine can meet that patient's needs.

A shortage can create exactly this type of situation if the licensed medicine that would ordinarily meet the requirement cannot be obtained and suitable licensed alternatives are not appropriate.

An unlicensed medicine should not simply be treated as another purchasing option because it is cheaper or easier to obtain.

10. Does an imported unlicensed medicine need MHRA approval?

The terminology matters here.

The importer must notify the MHRA before importing the medicine, but a “no objection” response is not the same as the medicine receiving a UK marketing authorisation.

The MHRA can:

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

SPS also makes clear that imported Specials have not undergone the same MHRA assessment for quality, safety and efficacy as a licensed UK medicine, so additional purchaser assurance is required.

11. How long does an MHRA unlicensed import notification take?

For a standard notification, the MHRA has a 28-day assessment period following acknowledgement.

Where justified, the MHRA may expedite the process. Its current guidance states that, for life-threatening or immediately injurious clinical emergencies, it may be able to assess a notification within two working days.

That does not mean the medicine itself can necessarily be delivered within two days.

Supplier availability, product assessment, documentation, freight, customs and temperature-control requirements may all affect the overall lead time.

12. Can an unlicensed medicine be imported from any country?

Potentially, but different licensing requirements apply.

MHRA guidance currently states that an unlicensed medicine imported from an approved country for import requires an appropriately authorised WDA(H). A medicine imported from a country outside that framework requires a Manufacturer's “Specials” Licence covering the import activity.

This is why finding stock internationally does not automatically mean a wholesaler can import it directly.

The regulatory route has to be established alongside the sourcing route.

13. Who can import an unlicensed medicine?

The importer must hold the appropriate MHRA authorisation for the proposed activity.

For products coming from an approved country for import, this can be an appropriately scoped Wholesale Dealer's Authorisation, WDA(H). Other source countries require a Manufacturer's “Specials” Licence for the relevant import.

Procurement teams should therefore verify the authorisation of the organisation handling the import rather than assuming that every pharmaceutical wholesaler can perform the same activities.

14. What should we check before purchasing an imported unlicensed medicine?

SPS recommends additional assurance because an unlicensed medicine has not undergone the normal UK marketing-authorisation assessment.

The purchaser should 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.

Depending on the product, teams may also need information covering:

manufacturer;
country of authorisation;
overseas marketing authorisation;
excipients;
concentration;
pack configuration;
storage;
shelf life;
labelling;
product information; and
supply-chain documentation.

Local pharmacy QA and governance procedures determine the assessment required for the individual organisation.

15. If the molecule and strength are the same, is the overseas medicine equivalent to the UK product?

Not necessarily.

Medicines containing the same active ingredient and nominal strength can still differ in characteristics including:

excipients;
concentration;
vial or ampoule volume;
administration device;
release characteristics;
preparation instructions;
storage requirements;
pack size;
appearance; and
labelling.

The proposed overseas product itself therefore needs to be assessed rather than relying only on the molecule name.

SPS specifically recommends confirming that an unlicensed medicine meets the purchasing specification and is suitable for the patient before purchase.

16. What if the packaging is not in English?

This is common with imported medicines and should form part of the local risk assessment.

Differences in language, packaging and presentation can increase the risk of medication error.

SPS guidance on unlicensed medicines recommends that governance and risk assessment consider packaging and labelling, including the possibility of misidentification or inappropriate use.

The appropriate mitigation will depend on the individual product and organisation.

17. Can procurement teams buy an unlicensed medicine before local approval is complete?

Local processes vary, but NHS SPS recommends that a quality assessment is completed before an unlicensed medicine is purchased for the first time.

Organisations should also have formal governance arrangements covering sourcing, purchasing, quality assessment, receipt, storage, record keeping and responsibilities for unlicensed medicines.

In practice, the sourcing investigation and local assessment will often progress alongside one another so that time is not lost unnecessarily during a shortage.

18. Can we ask a supplier to hold stock while we assess it?

Potentially, but this will depend on the supplier, product and market.

International shortage stock can move quickly, particularly where multiple countries are affected by the same supply problem.

It is therefore useful to tell the sourcing team early if:

internal approval is required;
QA documentation must be reviewed;
a purchase order may take time;
the requirement is still awaiting clinical confirmation; or
there is a hard deadline by which the product must be secured.

That allows the supplier to explain what can realistically be held and for how long.

19. Can we source only part of the quantity we need?

Yes, and during a shortage that may sometimes be the only immediately available option.

For example, a procurement team may identify:

limited UK stock for the immediate requirement;
mutual aid for a specific patient;
overseas stock for subsequent supply; or
several batches becoming available at different times.

This can result in a staged sourcing strategy rather than a single order solving the entire shortage.

For unlicensed medicines specifically, SPS notes that there are restrictions on quantities purchased at one time and that importers may therefore hold limited stocks.

20. How much shelf life should we expect?

There is no universal answer.

Available shelf life depends on the product and stock found.

Procurement teams should therefore state their minimum acceptable shelf life at the beginning of the enquiry rather than after a product has been identified.

If a shorter shelf life could be acceptable for an urgent requirement, it is useful to make that clear as well.

A product that is unsuitable for routine inventory may still potentially fulfil an immediate patient requirement, subject to local approval.

21. How quickly can Alcatia source a shortage medicine?

It depends entirely on the requirement.

Some enquiries can be resolved through existing authorised supply channels relatively quickly.

Others require:

an international search;
supplier qualification;
product documentation;
local QA assessment;
an MHRA import notification;
specialised transport; or
additional regulatory work.

The biggest factors are usually availability, quantity, source market and required delivery date.

This is why specifying when the medicine is actually needed is critical.

22. What information does Alcatia need from us?

At minimum:

Medicine or molecule
The exact product or active ingredient.

Strength
For example, 500 mg or 10 mg/ml.

Form
Tablet, capsule, oral solution, vial, ampoule, injection or another presentation.

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

Required-by date
The date by which the medicine needs to reach you.

It is also useful to include:

normal UK manufacturer or product;
preferred manufacturer;
pack size;
minimum shelf life;
storage conditions;
known shortage reference;
whether alternative presentations can be considered; and
any essential formulation requirements.

23. Do we need to know whether we need licensed or unlicensed supply?

No.

If you already know that only licensed stock can be considered, tell us.

If your organisation has approved consideration of an unlicensed import, tell us that too.

But if you simply know:

“We cannot source this medicine through our normal route”

that is enough to begin an enquiry.

Alcatia can investigate what supply options exist and provide information for your team to assess.

24. Does submitting a sourcing enquiry guarantee supply?

No.

Availability can change quickly, particularly during national or international shortages.

A sourcing request allows the team to investigate:

available stock;
manufacturers;
source markets;
quantities;
lead times;
licensing status; and
potential regulatory routes.

The resulting product still needs to meet the customer's procurement, clinical and governance requirements.

A sourcing enquiry should therefore be considered an investigation of viable options, not confirmation that the medicine can definitely be supplied.

25. Can Alcatia supply licensed and unlicensed medicines?

Alcatia Pharma Limited currently holds MHRA Wholesale Distribution Authorisation UK WDA(H) 59772.

The authorisation covers medicines with UK authorisation as well as medicines without UK authorisation intended for the UK market. Its authorised wholesale operations include procurement, supply, export and products imported from countries on the applicable approved list.

That allows Alcatia to investigate both conventional UK sourcing routes and appropriate specialist international supply options, depending on the product and circumstances.

26. When should we contact Alcatia?

Ideally, as soon as you believe normal supply may not meet the requirement.

You do not need to wait until the final pack has been used or every normal purchasing route has completely failed before asking whether alternatives exist.

Earlier enquiries provide more time to:

search different suppliers;
investigate international availability;
obtain documentation;
assess proposed products;
complete internal governance; and
arrange importation and logistics where required.

If the medicine is already urgently required, make the deadline clear when submitting the request.

The four pieces of information that matter most

When time is limited, start with four things:

What medicine?

Give us the molecule or product.

What exact presentation?

Give us the strength and pharmaceutical form.

How much?

Give us the quantity required.

By when?

Give us the required delivery date.

Those four pieces of information are enough for the sourcing team to begin establishing what may be possible.

Having difficulty sourcing a medicine?

Medicine shortage procurement is rarely about finding one universal solution.

The objective is to establish which supply routes remain available and which of those routes are appropriate for your organisation to consider.

Alcatia Pharma can investigate UK and international supply options for difficult-to-source medicines and provide the product information needed for your pharmacy team to assess the proposed route.

Tell us what you need

Medicine
Strength
Form
Quantity
Required-by date

This article provides general information for healthcare procurement and medicines-supply professionals. It does not constitute clinical, prescribing, legal or regulatory advice. Decisions concerning medicine shortages and the procurement and use of licensed or unlicensed medicines should be made by appropriately authorised professionals in accordance with current MHRA requirements, NHS guidance and applicable local governance procedures.

Can a UK Pharmaceutical Wholesaler Source Medicines from Overseas?

Alcatia — Thu, 13 Aug 2026 10:10:56 GMT

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:

remaining licensed UK stock;
another licensed strength or presentation;
another clinically appropriate licensed product; or
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.

How Specialist Pharmaceutical Importers Support NHS Medicine Shortages

Alcatia — Thu, 13 Aug 2026 09:59:14 GMT

When a medicine shortage affects the NHS, the first objective is not necessarily to find the same product somewhere else in the world.

Pharmacy and clinical teams may first need to conserve existing stock, consider alternative strengths or presentations, switch to another licensed medicine or follow specific national shortage guidance.

But there are situations where those options cannot adequately meet a patient's clinical need.

At that point, a specialist pharmaceutical importer can provide another route into the international medicines supply chain, identifying suitable products available overseas and managing the regulatory process required to bring an unlicensed medicine into the UK.

For NHS pharmacy procurement teams, this can turn a difficult question:

"Can anyone supply this medicine?"

into a much more structured sourcing exercise.

Having difficulty sourcing a medicine?

What is a specialist pharmaceutical importer?

A specialist pharmaceutical importer is an appropriately licensed organisation able to source medicines internationally and, where the regulatory conditions are met, import unlicensed medicinal products into the UK.

This is different from simply purchasing stock from an overseas wholesaler.

The MHRA regulates the importation of unlicensed medicines. Depending on where the medicine is sourced, an importer requires the appropriate Manufacturer's "Specials" Licence (MS) or Wholesale Dealer's Licence (WDA(H)) and must notify the MHRA of its intention to import the unlicensed product before importation.

These requirements mean specialist importers operate as part of a regulated supply route between international medicine markets and UK healthcare organisations.

Why are specialist importers relevant during medicine shortages?

Medicine shortages are not always global.

A licensed medicine may be unavailable in the UK because of:

manufacturing disruption;
increased demand;
supply-chain problems;
regulatory issues;
discontinuation;
allocation;
delays in replenishment; or
shortages affecting a particular strength or presentation.

At the same time, equivalent or potentially suitable medicines may still be commercially available elsewhere.

A product might, for example, be routinely marketed in Germany, France, the United States, Canada or another regulated market while the equivalent licensed UK product is unavailable.

That does not automatically mean the overseas medicine can or should be used in the NHS.

It does mean there may be another potential supply route worth investigating.

Where do specialist importers fit into the NHS shortage response?

Specialist importers are one part of a wider medicines-shortage response.

National Medicine Supply Notifications can recommend a range of actions depending on the product concerned.

These may include:

reviewing local stock holdings;
conserving remaining stock;
using another licensed strength or presentation;
switching to another clinically appropriate treatment;
using an alternative product off-label where appropriate; or
considering an unlicensed medicine where licensed alternatives are not suitable.

Current NHS shortage guidance specifically recognises circumstances in which unlicensed imports of the same medicine can be available in sufficient quantities to help meet a supply gap.

The specialist importer's role is therefore not to determine which medicine a patient should receive.

It is to help establish whether an appropriate product can be sourced and supplied through the required regulatory route.

What does a specialist importer actually do?

The visible part of the process for an NHS procurement team may simply be requesting a quote.

Behind that request can sit a much broader sourcing exercise.

1. Search international medicine markets

The first challenge is finding genuine available stock.

Specialist importers can investigate manufacturers, authorised wholesalers and supply partners across multiple countries rather than relying solely on normal UK distribution channels.

The search may consider:

active ingredient;
strength;
dosage form;
manufacturer;
source country;
pack configuration;
quantity;
shelf life;
storage requirements; and
expected lead time.

This is important because identifying a medicine by molecule alone is rarely sufficient.

A pharmacy team needs to know which actual product is available.

2. Identify the regulatory status of the product

A medicine available overseas may be:

licensed in the source country;
licensed in several international markets;
manufactured for a particular national market; but
unlicensed for supply in the UK.

The specialist importer establishes the product being proposed and the route through which it would need to enter the UK.

An imported product that does not have the appropriate UK marketing authorisation is treated as an unlicensed medicine, even where it is a routinely authorised commercial medicine in its home market.

3. Provide product information for pharmacy assessment

Finding stock is only part of the job.

NHS pharmacy teams also need sufficient information to assess whether the proposed medicine is appropriate for local use.

NHS Specialist Pharmacy Service guidance states that imported unlicensed medicines require assessment of their pharmaceutical quality and suitability. Information may include details about the manufacturer, overseas Marketing Authorisation Holder, regulatory status and characteristics of the specific product being offered.

A specialist importer may therefore need to obtain information covering areas such as:

manufacturer;
country of authorisation;
marketing authorisation details;
strength;
pharmaceutical form;
ingredients or excipients;
packaging;
storage requirements;
shelf life;
product literature; and
batch or quality documentation where applicable.

The NHS organisation can then undertake the appropriate local assessment.

Specialist importers do not replace local quality assurance

This distinction is particularly important.

An imported unlicensed medicine does not undergo the same central UK marketing-authorisation assessment as a licensed UK medicine.

NHS shortage notifications explicitly warn that unlicensed imports do not undergo a central quality assessment or suitability evaluation and should therefore be assessed locally in accordance with the organisation's unlicensed medicines procedures.

The specialist importer can support that process by supplying the required information.

The decision to approve and use the product remains with the appropriate healthcare professionals and NHS organisation.

4. Manage the MHRA import notification process

Where an unlicensed medicine is to be imported, the licensed importer must notify the MHRA before importation.

The notification process provides information about the proposed product and the special clinical need supporting its import.

After receiving a notification, the MHRA can:

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

The MHRA guidance provides for a notification assessment period of up to 28 days after acknowledgement, although urgent cases can be considered more quickly where justified.

A "no objection" position should not be interpreted as a UK marketing authorisation. The medicine remains unlicensed and the receiving healthcare organisation retains responsibility for its own clinical and quality assessment.

5. Coordinate international logistics

Even after a suitable source has been identified, the medicine still needs to reach the UK.

Depending on the product, that can involve:

supplier coordination;
international freight;
temperature-controlled transport;
customs processes;
import documentation;
warehouse receipt;
storage;
batch tracking; and
onward distribution.

For products with specialist handling requirements, the logistics can be as important as locating the stock itself.

A medicine that is theoretically available overseas is not useful to an NHS Trust if it cannot reach the pharmacy within the required timeframe and under appropriate storage conditions.

6. Establish realistic lead times

During a shortage, procurement teams often need a very simple answer:

When can we actually have it?

That answer depends on more than whether stock exists.

Lead times may be affected by:

the source country;
manufacturer availability;
quantity required;
supplier dispatch times;
regulatory notification;
documentation;
freight;
customs;
temperature-control requirements; and
whether stock is already held by the UK importer.

National Medicine Supply Notifications regularly warn pharmacy teams that lead times for unlicensed imports can vary and that orders should be placed within appropriate timeframes.

That makes the required-by date one of the most important pieces of information in any shortage sourcing enquiry.

7. Help procurement teams understand supply continuity

Finding ten packs is different from establishing a sustainable source.

Where a shortage is expected to last several months, procurement teams may need to understand:

how much stock is currently available;
whether further batches can be sourced;
typical replenishment lead times;
how much demand exists internationally;
whether another manufacturer is available; and
whether the proposed source is likely to remain viable.

This becomes especially important for medicines used in long-term treatment.

A specialist importer can investigate not only the immediate requirement but also the potential for continued supply if the UK shortage persists.

Why can't an NHS Trust simply order directly from overseas?

International medicine procurement involves regulatory responsibilities that do not apply to an ordinary domestic purchase.

The MHRA requires organisations importing unlicensed medicines to hold the appropriate licence and to complete the required notification process.

Using an appropriately licensed specialist importer therefore provides a regulated route through which the overseas product can be sourced and imported.

It also gives pharmacy teams a UK counterpart responsible for coordinating the international supplier, import process and associated product information.

When might an unlicensed import be considered?

Unlicensed medicines cannot simply be used as alternative commercial products whenever the licensed version is expensive or difficult to obtain.

MHRA guidance requires a special clinical need that cannot appropriately be met by an available authorised medicinal product. Supply based purely on cost, convenience or institutional preference does not constitute a valid special clinical need.

During a genuine medicine shortage, however, the licensed product that would ordinarily meet that need may no longer be available.

National shortage guidance may then specifically identify imported unlicensed medicines as an option where licensed alternatives are not appropriate.

This is where specialist pharmaceutical importers can become particularly relevant.

How do NHS Medicine Supply Notifications use specialist importers?

Medicine Supply Notifications sometimes identify specialist importers that have confirmed they can source a particular unlicensed medicine.

This gives pharmacy procurement teams potential supply routes to investigate alongside the clinical actions contained within the shortage notification.

For example, a February 2026 Medicine Supply Notification covering shortages of co-trimoxazole oral suspension stated that unlicensed supplies could be sourced and listed specialist importers that had confirmed availability.

Similarly, the June 2026 notification covering shortages of aztreonam 1 g and 2 g powder for solution for injection stated that specialist importers had sourced unlicensed products and that lead times varied.

These notifications demonstrate the practical role specialist importers can play when national medicine supply becomes constrained.

Alcatia Pharma and NHS medicine shortages

Alcatia Pharma has been named in official Medicine Supply Notifications as a specialist importer that confirmed it could source products affected by UK shortages.

For example:

Co-trimoxazole oral suspension

In February 2026, Alcatia Pharma was listed among the specialist importers that had confirmed they could source unlicensed co-trimoxazole 40 mg/200 mg/5 ml and 80 mg/400 mg/5 ml oral suspension during the relevant supply disruption.

Aztreonam injection

In June 2026, Alcatia Pharma was also listed among the specialist importers that had confirmed they could source unlicensed aztreonam 1 g and 2 g powder for solution for injection vials during a Tier 2 medicine supply issue.

These examples illustrate the role Alcatia can play: investigating international availability when conventional UK supply cannot meet demand.

They should not be interpreted as meaning an unlicensed import is automatically the appropriate solution for every shortage. The clinical and governance requirements described in the relevant shortage notification still apply.

What should procurement teams send to a specialist importer?

A sourcing investigation can move much faster when the requirement is clearly defined.

At minimum, provide:

Medicine

The exact medicine or active ingredient required.

Strength

For example:

1 g

rather than simply the medicine name.

Pharmaceutical form

For example:

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

Quantity

Provide the approximate number of packs, units, vials or doses required.

Required-by date

Tell us when the stock needs to arrive.

This allows the importer to distinguish between options that technically exist and those that could realistically meet your requirement.

What other information helps?

Where possible, include:

existing UK product;
preferred manufacturer;
pack size;
minimum shelf life;
storage requirements;
relevant Medicine Supply Notification;
whether alternative presentations can be considered;
expected duration of demand; and
any product characteristics that cannot be substituted.

You do not need to know which international market has stock.

That is what the sourcing investigation is designed to establish.

What should procurement teams ask a specialist importer?

When reviewing a potential unlicensed import, useful questions include:

What exact product have you sourced?
Who is the manufacturer?
In which country is it authorised?
Where will the product be sourced from?
How much stock is available?
What shelf life can be supplied?
What is the pack size?
What are the storage conditions?
What language is used on the packaging?
What product and quality documentation is available?
What is the expected lead time?
Is additional supply likely to remain available?
What regulatory route applies?

This information allows procurement, quality and clinical teams to assess the proposed product rather than making decisions based solely on price and availability.

Specialist sourcing works best when procurement starts early

During a national shortage, multiple healthcare organisations can be trying to source the same medicine at the same time.

International stock can therefore change quickly.

Waiting until the final packs are being used can significantly reduce the number of workable options.

Where a medicine is known to be entering shortage, procurement teams can engage specialist importers earlier to understand:

what international products exist;
which markets have stock;
indicative lead times;
whether supporting documentation can be obtained; and
whether continued supply could potentially be maintained.

That does not mean ordering unlicensed medicine before it is required.

It means obtaining enough supply intelligence to make better decisions if the shortage deteriorates.

Specialist importers support the procurement decision, not the clinical decision

This distinction should remain clear throughout the process.

The specialist importer can answer questions such as:

What products are available?

Where are they manufactured?

How much stock can be sourced?

How quickly could it reach the UK?

What documentation is available?

The pharmacy and clinical team determine:

Is this product appropriate for our patients?

Does the special clinical need exist?

Does it meet our quality requirements?

Should we use it?

The two functions work together, but they are not interchangeable.

Need help sourcing a medicine during a shortage?

If your usual UK supply route cannot meet a requirement, Alcatia Pharma can investigate potential sourcing options.

You do not need to know whether overseas stock exists before contacting us.

Tell us:

What medicine you need.
What strength and form you require.
How much you need.
When you need it.

Our sourcing team can investigate the available supply routes and provide the information needed for your pharmacy team to assess the options.

Having difficulty sourcing something?

This article is intended to provide general information for healthcare procurement and medicines-supply professionals. It does not constitute clinical, prescribing, legal or regulatory advice. Any decision to prescribe, procure or use an unlicensed medicine should be made by appropriately authorised professionals in accordance with current MHRA requirements, NHS guidance and applicable local governance procedures.

Licensed vs Unlicensed Medicines: What Procurement Teams Need to Know

Alcatia — Thu, 13 Aug 2026 09:50:12 GMT

For most pharmacy procurement, the distinction between a licensed and an unlicensed medicine is straightforward because the products being ordered through normal UK supply channels already hold the appropriate marketing authorisation.

During a medicine shortage, that distinction becomes much more important.

A licensed UK product may no longer be obtainable. Another strength or presentation may remain available. A licensed medicine might potentially be used outside the terms of its licence. Or an unlicensed product, including a medicine imported from another country, may need to be considered.

For procurement teams, understanding these different categories helps establish what can be sourced, what additional checks may be required and when specialist sourcing may be appropriate.

Having difficulty sourcing a medicine?

What is a licensed medicine?

A licensed medicine has been granted a Marketing Authorisation (MA) that is valid in the UK.

Before a medicine receives a marketing authorisation, its quality, safety and efficacy are assessed by the relevant medicines regulator for its intended use.

The marketing authorisation defines characteristics including:

the active ingredient;
strength;
pharmaceutical form;
indications;
patient population;
dose;
route of administration;
product information;
manufacturing requirements; and
conditions under which the medicine can be marketed.

For pharmacy procurement teams, licensed medicines generally provide the most straightforward sourcing route because their regulatory status, product information and quality requirements have already been established within the UK medicines framework.

Where an appropriate licensed medicine is available and meets the patient's clinical need, it will ordinarily be preferred to an unlicensed alternative. NHS Specialist Pharmacy Service guidance advises that a suitable licensed medicine should be used before an unlicensed medicine is considered.

What is an unlicensed medicine?

An unlicensed medicine is a medicinal product that does not have a Marketing Authorisation valid in the UK.

That does not necessarily mean the product is experimental, counterfeit or manufactured without regulatory oversight.

The term describes its UK licensing status.

For example, a medicine may be:

commercially manufactured;
routinely prescribed in another country;
licensed by another national medicines regulator; and
manufactured to recognised pharmaceutical standards;

while still being classed as an unlicensed medicine when supplied in the UK because it does not hold the required UK marketing authorisation.

Other unlicensed medicines may be specially manufactured in the UK by an organisation holding an appropriate Manufacturer's "Specials" Licence.

Both manufactured Specials and imported unlicensed medicines can fall within the UK's regulatory framework for unlicensed medicinal products.

Licensed vs unlicensed medicines at a glance

	Licensed medicine	Unlicensed medicine
UK Marketing Authorisation	Yes	No
Regulatory assessment for UK marketing authorisation	Completed	No UK MA assessment for the product
Routine supply	Normally permitted within usual supply arrangements	Restricted to circumstances permitted under medicines legislation
Clinical justification	Normal prescribing and procurement requirements	Special clinical need must exist
Product information	UK-approved SmPC and patient information available	May rely on manufacturer or overseas regulatory information
Local quality assessment	Usually less extensive	Additional assessment may be required
Imported product	May be possible through normal authorised routes	Specialist import requirements apply
MHRA import notification	Not generally an unlicensed medicine notification	Required where an unlicensed medicine is imported
Preferred where suitable	Yes	Used where an appropriate licensed option cannot meet the clinical need

The important point is that licensed and unlicensed medicines are not simply interchangeable purchasing options.

The regulatory and clinical basis for using them is different.

When can an unlicensed medicine be used?

UK legislation provides exemptions allowing unlicensed medicines to be manufactured, imported and supplied where there is a special clinical need.

MHRA guidance is clear that this need must relate to the clinical requirements of the patient. An unlicensed medicine should not be supplied simply because it is cheaper, more convenient or commercially preferable where an equivalent authorised product can meet the patient's needs.

This principle is particularly important for procurement teams.

The question is not:

"Can we buy this product unlicensed?"

It is:

"Is there an appropriate licensed medicine capable of meeting the patient's clinical need?"

If the answer is no, an unlicensed medicine may become relevant.

How does a medicine shortage change the situation?

Medicine shortages can remove the licensed option that would normally be used.

For example, a hospital may ordinarily purchase a particular licensed injection through established wholesalers. If that product becomes unavailable nationally, procurement teams may need to investigate several alternatives.

These might include:

Remaining licensed UK stock.
Another licensed presentation of the same medicine.
Another clinically appropriate licensed medicine.
Use of a licensed medicine outside the precise terms of its marketing authorisation.
An unlicensed medicine manufactured in the UK.
An imported medicine that is unlicensed in the UK.

NHS SPS guidance recommends considering alternative licensed presentations, other licensed medicines and potentially off-label use of licensed medicines before moving to an unlicensed medicine where these options are clinically appropriate.

The appropriate decision remains a clinical and pharmacy governance matter, but procurement teams play an important role in establishing which products are actually available.

Is an off-label medicine the same as an unlicensed medicine?

No.

This distinction can cause confusion.

A licensed medicine used off-label still has a UK Marketing Authorisation. The medicine itself is licensed, but it is being used in a way that falls outside the terms of its marketing authorisation.

That might relate to:

indication;
dose;
age group;
route of administration; or
another condition specified within the product licence.

An unlicensed medicine, by contrast, does not hold the relevant UK Marketing Authorisation at all.

From a procurement perspective, these are therefore different situations even if both require additional clinical consideration.

Are generic medicines unlicensed?

No.

A generic medicine can be fully licensed.

"Generic" and "unlicensed" describe entirely different characteristics of a medicine.

A licensed generic medicine has received the appropriate marketing authorisation and can normally be procured in the same way as other licensed medicines.

Likewise, a branded medicine may be unlicensed in the UK if the specific product does not hold an appropriate UK marketing authorisation.

Procurement teams should therefore avoid using generic, unlicensed, imported and off-label interchangeably.

Is an imported medicine automatically unlicensed?

No.

The important question is whether the specific product being supplied has an appropriate UK Marketing Authorisation.

However, during UK medicine shortages, international sourcing commonly involves medicines that are licensed for use in another country but do not hold a UK marketing authorisation.

Those products are therefore treated as unlicensed medicines when imported into the UK.

The importation of an unlicensed medicine is regulated. Depending on the source country, the importer must hold the appropriate MHRA Manufacturer's "Specials" Licence or Wholesale Dealer's Licence, and the MHRA must be notified before the proposed import takes place.

A pharmacy procurement team should therefore not treat international sourcing as simply ordering a medicine from an overseas wholesaler.

Does the MHRA approve imported unlicensed medicines?

Not in the same way that it approves a licensed medicine through the marketing authorisation process.

A licensed importer must notify the MHRA of the intention to import an unlicensed medicine.

The MHRA may:

raise no objection;
request additional information;
place conditions on the import; or
object to it.

However, NHS SPS emphasises that a "no objection" position does not represent a full assessment or approval of the product's quality, safety and suitability.

Responsibility remains with the purchaser and prescriber to ensure that the proposed medicine is appropriate.

That has important consequences for procurement and pharmacy quality assurance teams.

Why do unlicensed medicines require additional procurement checks?

With a licensed UK medicine, much of the product's regulatory assessment has already been undertaken as part of the marketing authorisation process.

With an unlicensed medicine, additional local assurance may be required.

For an imported unlicensed medicine, NHS SPS recommends obtaining enough information to establish that the product:

is of appropriate pharmaceutical quality;
matches the purchasing specification;
is suitable for the patient; and
is packaged and labelled in a way that minimises medication errors.

Depending on the product, procurement and quality teams may therefore need information such as:

manufacturer;
Marketing Authorisation Holder in the source market;
country of authorisation;
overseas marketing authorisation number;
manufacturing standards;
batch documentation;
strength and concentration;
pharmaceutical form;
excipients;
pack configuration;
storage requirements;
shelf life;
product information; and
labelling language.

The precise assessment will depend on the medicine and the organisation's local governance procedures.

Can the overseas product be different from the UK medicine?

Yes.

Two medicines can contain the same active ingredient and strength without being identical products.

Differences may include:

excipients;
vial size;
total volume;
concentration;
administration device;
release characteristics;
pack size;
storage requirements;
preparation instructions;
appearance;
labelling; and
patient information.

This is why international sourcing should identify the specific product being offered, rather than simply confirming that the molecule can be obtained.

For pharmacy procurement teams, "we have found the medicine" is only the beginning of the assessment.

What should procurement teams prioritise?

When faced with a difficult sourcing requirement, it is useful to separate two questions.

What is clinically acceptable?

This is determined by the appropriate clinical, prescribing and pharmacy governance teams.

What is commercially and operationally available?

This is where procurement teams and specialist sourcing partners can help.

The sourcing process can establish:

whether licensed UK stock remains available;
whether alternative strengths or presentations exist;
whether the medicine is available internationally;
potential manufacturers and source markets;
quantities available;
shelf life;
pack configuration;
lead times;
transport requirements; and
indicative cost.

The clinical team can then assess available options with much better information.

What information should a sourcing enquiry include?

Whether you require licensed or unlicensed supply, providing a precise requirement will make the search substantially more effective.

Alcatia recommends including:

Medicine or active ingredient

Give the exact product or molecule required.

Strength

For example:

500 mg

rather than only the medicine name.

Pharmaceutical form

For example:

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

Quantity

Give the approximate number of packs, vials, units or doses required.

Required-by date

This helps determine which sourcing routes are realistically viable.

Licensed, unlicensed or unsure

If you already know the required route, tell us.

If you do not, unsure is perfectly acceptable.

You do not need to determine the regulatory route before submitting an enquiry.

Additional requirements

Where relevant, include:

preferred manufacturer;
pack size;
minimum shelf life;
storage conditions;
existing UK product;
known shortage information; and
any product characteristics that cannot be substituted.

Licensed should not mean "stop searching"

Where an appropriate licensed medicine remains available, that is normally the preferred route.

But "unavailable through our normal wholesaler" does not necessarily mean "unavailable".

A shortage investigation can include checking alternative authorised supply routes before considering unlicensed supply.

Equally, if UK licensed stock genuinely cannot meet the requirement, the sourcing exercise should not necessarily end there.

An appropriate imported or manufactured unlicensed medicine may provide another option where the required special clinical need exists and the relevant regulatory and local governance requirements can be satisfied.

The purpose of specialist sourcing is therefore not simply to find an unlicensed medicine.

It is to understand the available supply routes and identify realistic options for the pharmacy team to assess.

Need help determining what can be sourced?

If a licensed medicine has become difficult or impossible to obtain, Alcatia Pharma can investigate the available supply options.

Tell us:

What medicine you need.
What strength and form you require.
How much you need.
When you need it.

If you are unsure whether licensed or unlicensed supply is appropriate, you can still submit the requirement.

Our sourcing team can investigate what is available and provide the product information your team needs to assess the options.

Having difficulty sourcing something?

This article is intended to provide general information for healthcare procurement and medicines-supply professionals. It does not constitute clinical, prescribing, legal or regulatory advice. Decisions concerning the procurement, prescribing and use of licensed, off-label or unlicensed medicines should be made by appropriately authorised professionals in accordance with current MHRA requirements, professional guidance and applicable local governance procedures.

How Long Does It Take to Source an Unlicensed Medicine?

Alcatia — Thu, 13 Aug 2026 09:33:55 GMT

When a licensed medicine becomes unavailable in the UK, one of the first questions pharmacy procurement teams need answered is straightforward:

How quickly can an unlicensed alternative be sourced?

There is no single lead time.

An imported unlicensed medicine may sometimes be sourced relatively quickly, particularly where an appropriate product and established supply route have already been identified. A new or complex sourcing requirement can take considerably longer.

The overall timeline depends on several separate stages: identifying suitable stock, obtaining product and quality information, completing the appropriate regulatory process, arranging international transport and delivering the medicine to the customer.

For procurement teams facing an active shortage, the most important principle is therefore simple:

Start the sourcing process as soon as a potential supply problem is identified.

Need us to investigate a current requirement?

Why isn't there a standard lead time for unlicensed medicines?

Purchasing an unlicensed medicine is not the same as placing a routine order for a licensed UK product.

NHS Specialist Pharmacy Service describes purchasing Specials, including imported unlicensed medicines, as generally more complicated than purchasing licensed medicines. Procurement may require the evaluation of several possible options, identification of a suitable importer, assessment of the medicine's quality and checks when the product is received.

That means there are effectively several different lead times within a single sourcing request.

A useful way to think about the process is:

Requirement → Product search → Product assessment → Regulatory process → International logistics → Delivery

The speed of each stage depends on the medicine involved.

Stage 1: Identifying the medicine you actually need

The first factor affecting the timeline is the quality of the sourcing request.

Before an importer can search effectively, it needs to know exactly what the pharmacy requires.

At minimum, that should normally include:

medicine or active ingredient;
strength;
pharmaceutical form;
quantity required; and
required-by date.

Additional requirements might include:

particular manufacturer or brand;
pack size;
route of administration;
minimum shelf life;
storage requirements;
concentration;
formulation requirements; or
other clinically significant characteristics.

NHS SPS recommends that pharmacy teams establish a purchasing specification for an unlicensed medicine, including characteristics such as drug, route, form, strength, excipients, quantity and any specific labelling requirements. It may also be necessary to distinguish between characteristics that are essential and those that are merely desirable.

Why does this affect sourcing time?

Consider two enquiries:

Enquiry A:
"Can you source Drug X?"

Enquiry B:
"Drug X, 1 g powder for solution for injection, 20 vials, minimum six months' shelf life, required within two weeks."

The second enquiry gives a sourcing team a much clearer specification against which potential international products can be assessed.

Missing information can create delays because products may be identified only to discover later that the strength, presentation, quantity or delivery date does not meet the requirement.

Stage 2: Finding suitable international stock

Once the requirement is clear, the importer needs to identify a potential source.

This can be relatively straightforward where:

the product is routinely available internationally;
an established manufacturer and supplier are known;
the importer has previously sourced the medicine;
sufficient stock is available; and
the proposed product meets the customer's requirements.

It can take longer when:

the shortage is affecting several countries;
international demand is high;
manufacturers are allocating stock;
the required presentation is unusual;
only small quantities exist;
a specific manufacturer is required; or
several possible products need to be evaluated.

A UK shortage can also create international competition for the same medicine. Finding that a medicine is licensed overseas does not necessarily mean sufficient exportable stock is immediately available.

This is why the answer to "Can this medicine be sourced?" and "How quickly can it be delivered?" can change rapidly during an active shortage.

Stage 3: Obtaining the information needed to assess the product

Finding stock is only part of the process.

An overseas product also needs to be assessed to determine whether it is an appropriate option for the intended requirement.

Imported Specials are not subject to a full MHRA assessment of their quality, safety and efficacy as a UK licensed medicine would be. NHS SPS therefore advises purchasers to obtain sufficient information from suppliers to establish that the product is of appropriate pharmaceutical quality, meets the purchasing specification and is packaged and labelled in a way that minimises medication error.

Information required can vary considerably between products.

It may include:

manufacturer information;
country of licensing;
marketing authorisation details;
product information;
labels;
patient information leaflets;
certificates of analysis;
certificates of conformity;
GMP information; and
supply-chain documentation.

The MHRA similarly requires supporting information as part of an import notification, which may include evidence that the product is licensed in its country of origin, GMP documentation, certificates of analysis and evidence of clinical need or UK product unavailability.

This can be one of the biggest variables in the timeline

If an established supplier can provide the required documentation promptly, the process can move forward.

If information is incomplete, requires translation or has to be obtained from a manufacturer, additional time may be required.

NHS SPS advises that information supporting the local quality assessment should be readily available from the supplier and that an alternative supplier should be considered if appropriate information cannot be provided.

Stage 4: MHRA notification

This is the part of the process where it is particularly important not to confuse the regulatory timeframe with the total sourcing lead time.

Appropriately licensed importers must notify the MHRA before importing an unlicensed medicine into the UK. The notification must include supporting evidence relating to relevant manufacturing and distribution standards and the special clinical need for the medicine.

After receiving a notification, the MHRA issues an acknowledgement.

For the standard process, the MHRA can assess the notification during a 28-day period from acknowledgement. During this period it may confirm that it has no objection to the import, request further information or object to the proposed import.

That does not mean every unlicensed medicine takes 28 days to source.

The 28-day period is one regulatory component of the process, not a guaranteed delivery time.

It also does not mean that an importer should simply wait 28 days regardless of circumstances. The MHRA specifically provides mechanisms for expedited and urgent notifications.

Can the MHRA process be expedited during a medicine shortage?

Potentially.

The MHRA's notification system specifically recognises imports intended to mitigate a UK shortage of licensed medicines, alongside standard and urgent clinical-need notifications.

Where justified, the MHRA may expedite its assessment and waive the normal 28-day period to enable faster access to critical medicines.

For life-threatening or immediately injurious clinical emergencies, current MHRA guidance states that it may be possible to process and assess an import notification within two working days.

However, this should not be interpreted as a two-day delivery service.

The product still needs to be identified and available, the required information must be assembled, the justification for urgency must be provided and the medicine then needs to travel through the appropriate supply chain.

Stage 5: International shipping and import

Once the appropriate supply and regulatory requirements are in place, the physical medicine still needs to reach the UK.

The logistics timeline depends heavily on the product.

Factors can include:

source country;
supplier dispatch time;
transport method;
customs processes;
temperature requirements;
dangerous-goods requirements where applicable;
weekend and public-holiday timings;
product availability;
shipment size; and
onward delivery within the UK.

A room-temperature medicine available from a nearby established supplier presents a different logistics challenge from a temperature-sensitive medicine being sourced from a distant market.

For this reason, the location of the stock is not simply a pricing consideration. It can materially affect whether the proposed supply can meet the required date.

So how long should a pharmacy procurement team allow?

There is no responsible universal answer such as "five days" or "two weeks".

A better way to assess the likely timeline is to ask how many parts of the sourcing route are already established.

A potentially faster requirement

The process may move more quickly where:

the medicine has previously been sourced;
a suitable overseas product is already known;
the supplier relationship is established;
appropriate documentation is readily available;
stock is immediately available; and
the logistics route is straightforward.

A potentially longer requirement

More time may be needed where:

this is a completely new medicine request;
several international products need to be compared;
a new supplier must be qualified;
documentation needs to be obtained;
there are pharmaceutical quality questions;
the MHRA requests further information;
the medicine is temperature-sensitive;
stock is geographically distant; or
the shortage is creating heavy international demand.

Where the MHRA requests further information, its guidance states that the medicine cannot be imported until the MHRA subsequently permits the import to proceed.

The practical lead time can therefore range from a relatively straightforward sourcing exercise to a process lasting several weeks.

What information can speed up a sourcing request?

Procurement teams cannot control every part of the process, but they can remove avoidable delays.

When contacting Alcatia, provide as much of the following information as possible:

Medicine

Include the generic name and brand where relevant.

Strength

For example, 500 mg or 1 g.

Pharmaceutical form

For example:

tablet;
capsule;
vial;
ampoule;
injection;
oral solution; or
pre-filled syringe.

Quantity

Tell us the approximate quantity required.

Required-by date

Do not simply mark an enquiry "urgent" if you know the actual date.

A specific required-by date allows the sourcing team to determine immediately whether a potential supply route is realistic.

Current product

If possible, provide details of the product you would normally purchase.

Essential requirements

Tell us what cannot change.

For example:

strength;
concentration;
route;
formulation;
pack requirements;
minimum shelf life; or
manufacturer.

Flexible requirements

It is equally useful to know which characteristics could potentially vary, subject to your organisation's assessment.

That may allow the sourcing team to investigate a wider set of potential options.

Don't wait until the final pack is used

One of the most useful things a procurement team can do during a developing shortage is investigate alternative supply before existing stock is exhausted.

If normal wholesaler availability is deteriorating, allocation is tightening or a manufacturer has indicated a prolonged disruption, beginning an international sourcing investigation early can provide valuable additional time.

It allows time to:

identify potential overseas products;
obtain supplier and product information;
conduct the necessary local assessment;
complete regulatory requirements; and
arrange logistics.

You do not necessarily need to have decided to purchase an unlicensed medicine before starting the conversation.

Sometimes the most useful first question is simply:

"If our existing supply fails, what options could be available?"

What if the requirement is extremely urgent?

Make that clear at the beginning of the enquiry.

Provide the actual required-by date and any information explaining the clinical urgency.

The MHRA allows justified expedited notifications, including a potential two-working-day assessment route for life-threatening or immediately injurious clinical emergencies.

Whether the medicine itself can reach the customer within the necessary timeframe will still depend on stock, documentation and logistics.

An urgent request is therefore best treated as a supply feasibility exercise rather than assuming that an unlicensed import will automatically provide an immediate solution.

How Alcatia approaches an urgent sourcing request

When you provide a medicine requirement, the first task is to establish whether a viable supply option can be identified.

That means understanding:

What do you need?
How much do you need?
When do you need it?
What characteristics are essential?

Alcatia can then investigate potential international sources and provide the relevant product, availability and lead-time information for your procurement and pharmacy teams to assess.

Where no realistic option exists within the required timeframe, knowing that quickly is also valuable.

The purpose of the sourcing process is not simply to find a product somewhere in the world. It is to identify a supply route that can realistically meet the requirement.

Need to know whether a medicine can be sourced in time?

The earlier you send the requirement, the more time there is to investigate the available options.

Tell us:

Medicine
Strength
Form
Quantity
Required-by date

Having difficulty sourcing something?

Alcatia Pharma can investigate potential supply options and provide an indication of availability and lead time for your team to assess.

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

What to Do When Your Usual Pharmaceutical Supplier Can't Supply a Medicine

Alcatia — Mon, 10 Aug 2026 15:57:11 GMT

A supplier telling you that a medicine is unavailable does not necessarily mean the medicine cannot be sourced.

It means your usual supply route has failed.

For pharmacy procurement teams, the next step is to establish whether the issue is local to that supplier, part of a wider UK shortage, or evidence that the licensed product is genuinely unavailable across the market.

From there, there may be several options: alternative wholesalers, different presentations, mutual aid, alternative licensed medicines or, where clinically appropriate, an imported unlicensed medicine.

The key is to move quickly while keeping the requirement precise.

If your usual supplier cannot supply a medicine, Alcatia Pharma can investigate alternative sourcing options.

First: establish exactly what "unavailable" means

Not every failed order represents a national medicine shortage.

A supplier may be unable to fulfil an order because:

its own stock has been exhausted;
stock has been allocated;
the manufacturer has restricted distribution;
a particular pack size or presentation is unavailable;
there is a temporary wholesaler issue;
demand has increased unexpectedly;
the manufacturer has experienced a supply disruption; or
the product has been discontinued.

Manufacturers have a legal obligation to notify the Department of Health and Social Care of medicine shortages and discontinuations that meet the relevant reporting criteria. DHSC and NHS England then assess notified supply issues and determine what action may be required.

For a procurement team, however, the immediate question is simpler:

Can the medicine still be sourced somewhere else?

Step 1: Confirm the requirement

Before contacting alternative suppliers, make sure you know exactly what you need.

Record:

medicine or active ingredient;
brand, if clinically relevant;
strength;
pharmaceutical form;
pack size;
quantity required;
current stock position;
expected usage;
required-by date; and
whether alternative presentations can be considered.

This prevents a common problem during shortages: searching for a product name without defining which characteristics are genuinely essential.

For example:

"We need 50 packs of Drug X"

is considerably less useful than:

"We require 50 packs of Drug X 500 mg tablets, ideally 28 tablets per pack, required within seven days."

The second request gives a sourcing team something actionable.

Step 2: Check whether the problem extends beyond your normal supplier

Your first supplier being out of stock does not automatically mean all UK supply has disappeared.

Depending on your organisation and procurement arrangements, it may be appropriate to investigate:

other contracted wholesalers;
alternative authorised wholesalers;
the manufacturer;
specialist pharmaceutical suppliers; or
other established supply routes available to your organisation.

Availability can differ between suppliers because different businesses have different stock holdings, allocations and distribution arrangements.

The objective at this stage is to establish whether licensed UK stock remains available elsewhere before moving to more complex alternatives.

Step 3: Check whether there is an official supply issue

If the problem appears wider than a single supplier, establish whether the medicine is affected by a recognised shortage.

In England, DHSC and NHS England manage national medicine supply issues, and information for healthcare professionals may be communicated through Medicine Supply Notifications (MSNs) and the NHS Medicines Supply Tool hosted by Specialist Pharmacy Service.

These communications can provide important information such as:

expected duration of the shortage;
products affected;
remaining availability;
alternative products;
clinical management recommendations; and
whether additional sourcing routes are being used.

For secondary care NHS pharmacy procurement teams, SPS also publishes specific guidance on navigating potential supply issues before escalation to regional procurement teams.

An official shortage notice can therefore change the sourcing strategy considerably.

Step 4: Establish how much stock you actually need

During a shortage, it is important to distinguish between the amount you would normally order and the amount you actually need to protect patient supply.

Ask:

How much stock is currently available?

What is the normal daily or weekly usage?

How many patients depend on the medicine?

How long will the existing stock last?

When is the next normal delivery expected?

This allows the team to calculate the genuine supply gap.

If you normally purchase 200 packs per month but currently need only 30 additional packs to bridge a two-week disruption, a smaller alternative source may be sufficient.

That can materially increase the number of viable sourcing options.

Step 5: Consider alternative presentations of the licensed medicine

Sometimes the shortage affects only one presentation.

Depending on the medicine, there may still be availability in:

another strength;
another pack size;
another pharmaceutical form;
another licensed brand; or
an alternative manufacturer.

Whether any of these products are clinically interchangeable is a decision for the appropriate pharmacy and clinical teams.

From a procurement perspective, however, identifying what is available can help those teams assess the options.

This is another reason sourcing enquiries should clearly distinguish between essential product characteristics and preferences.

Step 6: Consider an alternative licensed medicine

A shortage may sometimes be managed using a different licensed medicine.

National supply guidance may provide recommendations for clinically appropriate alternatives, and more significant shortages can result in additional national actions such as Serious Shortage Protocols. DHSC states that SSPs may be used where an alternative medicine or quantity can be supplied by a pharmacy under the relevant protocol.

This is not primarily a procurement decision.

The appropriate clinical, medicines information and pharmacy teams should determine whether an alternative therapy is suitable.

Procurement can then establish whether adequate supply of the recommended alternative is available.

Step 7: Consider mutual aid where appropriate

For NHS hospital pharmacies, mutual aid can sometimes help when conventional supply routes cannot provide medicine quickly enough.

SPS describes this as the transfer of medicines between NHS hospitals in circumstances including national shortages, sudden increases in demand or urgent requirements for medicines that are not normally stocked.

However, mutual aid is intended for exceptional circumstances rather than as an alternative routine supply chain. SPS advises that normal supply options should be exhausted first.

For NHS secondary care organisations, regional SPS procurement teams can help assess whether mutual aid is appropriate and may have visibility of stock held by other trusts.

This can be particularly useful where only a small quantity is required urgently for a specific patient.

Step 8: Investigate international supply

If licensed UK stock cannot be obtained, there may still be commercially available stock elsewhere in the world.

A medicine unavailable in the UK might still be routinely marketed in:

Europe;
North America;
Asia;
Australia;
or another regulated pharmaceutical market.

This is where specialist sourcing companies can become particularly useful.

Instead of a pharmacy procurement team contacting individual overseas suppliers, a specialist importer can investigate markets, manufacturers and authorised distribution channels to determine whether a viable product exists.

The first objective is simply to answer:

Does an appropriate product exist, where is it available and how quickly could it reach the UK?

Step 9: Consider whether an unlicensed import may be appropriate

If the licensed UK medicine is unavailable and an appropriate product exists overseas, unlicensed importation may sometimes be relevant.

Under Regulation 167 of the Human Medicines Regulations 2012, an unlicensed medicine may be supplied where no available licensed medicine can meet the clinical needs of an individual patient. The clinical need is determined by the responsible prescriber.

An overseas medicine may therefore be:

commercially manufactured;
licensed in its home market;
routinely used in that country; but
considered unlicensed when supplied in the UK.

This does not make unlicensed imports a general substitute for licensed UK medicines.

They are a regulated route intended to address a genuine clinical requirement where available licensed options cannot meet that need.

Step 10: Use an appropriately licensed importer

A pharmacy should not simply locate an overseas website or wholesaler and arrange for medicine to be shipped into the UK.

Unlicensed medicine importation is regulated by the MHRA.

Depending on the source country, an importer requires the appropriate Manufacturer's "Specials" Licence or Wholesale Dealer's Licence, and the MHRA must be notified of the intention to import the unlicensed medicine before the import takes place.

The notification process requires supporting evidence concerning:

appropriate manufacturing and distribution standards; and
the special clinical need for the medicine.

Using a specialist importer therefore provides a structured route for investigating international availability while meeting the relevant regulatory requirements.

What information should you ask an alternative supplier for?

Finding someone who says "we can source it" is only the beginning.

Before proceeding, procurement teams should understand exactly what is being offered.

Ask for information including:

Exact product

Confirm:

active ingredient;
strength;
pharmaceutical form;
brand or manufacturer;
pack size; and
presentation.

Regulatory status

Establish:

whether the product is UK licensed;
whether it is licensed in another market;
or whether it would be supplied as an unlicensed medicine.

Source

Ask:

where the medicine is manufactured;
where the stock is currently located; and
through which supply chain it will reach the UK.

Quantity

Confirm how much physical stock is actually available.

"There is availability" is not the same as confirmation that your required quantity can be supplied.

Shelf life

Shortage stock can sometimes come from limited international inventories, so remaining shelf life should be established before purchase.

Lead time

Ask for a realistic estimate that takes account of:

supplier preparation;
transportation;
regulatory processes;
customs;
cold-chain requirements where relevant; and
final UK delivery.

Continuity

If the UK shortage is expected to last several months, ask whether further quantities are likely to be available.

A source that resolves today's requirement but cannot support subsequent demand may still be useful, but the limitation should be understood.

Avoid one of the biggest shortage procurement mistakes

When supply becomes difficult, there is an understandable temptation to ask every potential supplier:

"How many can you get?"

A better question is:

"We need X quantity by Y date. What viable options can you identify?"

This matters because pharmaceutical sourcing is not simply a stock search.

Different options may involve different:

manufacturers;
countries;
pack configurations;
licence status;
lead times;
shelf lives;
prices; and
regulatory requirements.

Giving the supplier a defined requirement allows them to find the best route for the actual problem rather than simply quoting whatever stock happens to be available.

What should you send Alcatia when your supplier cannot supply?

You do not need to conduct an international search yourself.

Send us the requirement.

At minimum, provide:

Medicine or molecule
The product you are trying to source.

Strength
For example, 500 mg or 10 mg/ml.

Form
Tablet, capsule, vial, ampoule, oral solution, injection or other presentation.

Quantity
How much you need.

Required-by date
When the medicine needs to arrive.

It is also useful to tell us:

your organisation;
the normal product or manufacturer;
pack size;
whether this relates to a known shortage;
whether alternative presentations can be considered;
minimum shelf-life requirements;
storage requirements; and
any previous sourcing attempts.

You can select licensed, unlicensed or unsure when submitting the enquiry.

You do not need to determine the sourcing route before contacting us.

What happens after Alcatia receives the requirement?

We can investigate the available supply options based on the information provided.

Depending on the product, this may involve examining:

available licensed supply;
alternative UK supply channels;
specialist pharmaceutical sources;
international availability;
potential unlicensed imports; and
realistic lead times.

If a potential product is identified, we can provide relevant information for your procurement and pharmacy teams to assess.

That may include:

manufacturer;
source market;
strength and presentation;
pack size;
available quantity;
shelf life;
regulatory status;
pricing; and
indicative delivery time.

Availability can change quickly, particularly when multiple healthcare organisations are responding to the same shortage.

The earlier the enquiry is submitted, the more time there is to investigate alternatives.

Your usual supplier being out of stock is the start of the investigation, not necessarily the end

Medicine supply chains are complex.

A failure through one route can sometimes be resolved through another licensed supplier. In other circumstances, the solution may involve another presentation, mutual aid or a clinically appropriate alternative.

And when the licensed UK market cannot meet the requirement, specialist international sourcing may provide another option.

The important thing is to define the requirement accurately and start investigating before local stock reaches a critical level.

Can't source a medicine through your normal supplier?

Tell Alcatia:

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

We'll investigate the available sourcing options.

This article is intended to provide general information for healthcare procurement and medicines-supply professionals. It does not constitute clinical, legal or regulatory advice. Decisions concerning alternative products or unlicensed medicines should be made by appropriately authorised professionals in accordance with current MHRA and NHS guidance and local governance procedures.

What Information Does a Pharmaceutical Wholesaler Need to Source a Medicine?

Alcatia — Mon, 10 Aug 2026 15:42:06 GMT

When a medicine becomes difficult to obtain, the first instinct is often simply to ask:

“Can you source this product?”

But for a pharmaceutical wholesaler or specialist importer to investigate the requirement properly, a product name alone is rarely enough.

The exact strength, pharmaceutical form, quantity, timing and product requirements can completely change what supply options are available.

A clear sourcing request allows the wholesaler to search the right markets, identify appropriate stock more quickly and avoid wasting time investigating products that will not meet the pharmacy or procurement team's requirements.

This guide explains the information Alcatia Pharma needs when you ask us to source a medicine, and why each detail matters.

Having difficulty sourcing something?

What information should you provide when asking a wholesaler to source a medicine?

For most sourcing enquiries, the essential information is:

Medicine or active ingredient
Strength
Pharmaceutical form
Quantity required
Required-by date
Whether the requirement relates to a current shortage
Whether licensed or unlicensed supply is required, if known
Organisation and contact details

Additional information such as manufacturer, pack size, minimum shelf life or storage requirements can make the search considerably more precise.

The more complete the requirement, the easier it is to determine whether a viable source exists.

1. Medicine name or active ingredient

Start with the exact medicine you require.

This could be:

Generic name:
Aztreonam

Active ingredient:
Aztreonam

Brand name:
Where a particular branded medicine is required

Ideally, provide both the generic and brand name where relevant.

This helps avoid ambiguity, particularly where several products share similar names or where different manufacturers market the same molecule in different countries.

If you have the details of the product you normally purchase, include them.

2. Strength

Strength is essential.

For example:

Aztreonam 1 g

is a significantly more useful sourcing request than:

Aztreonam

The same medicine may be available in several strengths, and a shortage may affect one strength while another remains available.

Examples include:

5 mg tablets
20 mg/ml oral solution
500 mg capsules
1 g powder for solution for injection
100 micrograms/dose inhaler

Where relevant, include the concentration as well as the total quantity in the container.

3. Pharmaceutical form

Tell the wholesaler exactly what dosage form is required.

Examples include:

Tablets
Capsules
Oral solution
Suspension
Cream
Ointment
Eye drops
Pre-filled syringe
Vial
Ampoule
Powder for solution for injection
Solution for infusion
Inhaler
Suppository

This matters because different formulations are not automatically interchangeable.

An internationally available tablet does not solve a requirement for an injectable medicine, even where the active ingredient and strength appear similar.

For injectable medicines, additional detail about the formulation or presentation can be particularly important.

4. Quantity required

Specify approximately how much stock you need.

This might be:

20 packs

or:

200 vials

rather than simply saying that you need the medicine urgently.

Quantity matters because international availability can vary significantly.

A supplier may be able to provide ten packs immediately but not 500. Conversely, a manufacturer or larger wholesaler may only consider supply above a particular volume.

Knowing the quantity at the beginning allows the sourcing team to focus on suppliers capable of fulfilling the actual requirement.

Packs, units or doses?

Where possible, be explicit.

For example:

50 packs of 10 vials

is clearer than:

If you only know the clinical requirement rather than the pack configuration, provide that information and the sourcing team can investigate the available pack sizes.

5. Required-by date

This is one of the most important pieces of information in any medicine sourcing enquiry.

Tell the wholesaler when you need the stock.

For example:

Required within 48 hours

Required by 21 August

Required within two weeks

International sourcing may involve:

supplier lead times;
regulatory processes;
export arrangements;
transport;
customs;
temperature-controlled distribution; and
final delivery.

A product may technically be available but not be capable of reaching the customer within the required timeframe.

Providing a realistic required-by date helps distinguish a viable sourcing option from one that is simply too slow.

6. Is the medicine currently in shortage?

Tell the supplier whether the request relates to a known UK medicine shortage.

Useful information can include:

a Medicine Supply Notification;
National Patient Safety Alert;
manufacturer communication;
wholesaler allocation;
discontinued product notice; or
another known supply restriction.

This provides context for the enquiry and can help the sourcing team understand whether alternative or international supply routes may be relevant.

You can still submit an enquiry if the medicine is not listed on a national shortage notice.

Local and regional supply difficulties often occur before, or without, a formal national notification.

7. Do you need licensed or unlicensed supply?

If you know the answer, tell us.

Typical responses might be:

Licensed UK supply only

Unlicensed import can be considered

Unsure

It is completely acceptable to select unsure.

You do not need to determine the appropriate regulatory route before contacting a specialist pharmaceutical wholesaler.

In many cases, the first stage of the search is establishing what supply routes actually exist.

If licensed UK stock is available, that may be the appropriate route to investigate first.

Where licensed supply cannot meet a genuine clinical need, an imported unlicensed medicine may sometimes become relevant, subject to the appropriate clinical, regulatory and local governance processes.

8. Manufacturer or brand requirements

If a particular manufacturer is required, state this clearly.

For example:

Manufacturer X only

or:

Any manufacturer can be considered

This distinction can dramatically widen or narrow the search.

During a shortage, procurement teams may sometimes be willing to consider an alternative manufacturer provided the product passes the appropriate quality and clinical assessment.

In other cases, the manufacturer may be essential because of:

patient requirements;
device compatibility;
excipients;
formulation;
continuity of treatment; or
local formulary restrictions.

If the manufacturer is a preference rather than an absolute requirement, make that clear too.

9. Pack size

Pack size is another useful detail.

For example:

30 tablets per pack

10 vials per pack

100 ml bottle

Overseas products frequently have different pack configurations from their UK equivalents.

A medicine normally supplied as a UK pack of 28 tablets might be marketed elsewhere in packs of 30, 50 or another quantity.

Knowing whether the pack size is essential or flexible helps the wholesaler assess more possible options.

10. Minimum shelf life

If your organisation has a minimum acceptable shelf-life requirement, include it from the beginning.

For example:

Minimum six months remaining shelf life on delivery

This is particularly important during shortages because the available international stock may already be part-way through its commercial shelf life.

Without a minimum requirement, a sourcing team may identify technically available stock that your organisation would subsequently be unable to accept.

If your normal shelf-life requirement can be relaxed for urgent shortage supply, indicate this where appropriate.

11. Storage and transport requirements

Tell the supplier about any specific storage requirements.

Examples include:

ambient;
refrigerated 2°C to 8°C;
frozen;
protection from light; or
another controlled condition.

Cold-chain products require different sourcing and logistics arrangements from ordinary ambient medicines.

International transportation can therefore have a significant impact on both lead time and cost.

For temperature-sensitive medicines, the sourcing team also needs to determine whether the proposed supply chain can maintain the required conditions throughout transit.

12. Country or market restrictions

Sometimes a procurement team may have restrictions relating to where a medicine can be sourced.

If so, tell the supplier.

For example:

EEA markets preferred;
specific countries acceptable;
particular markets excluded; or
no restriction subject to appropriate regulatory and quality assessment.

This can affect the number of viable supply options.

If you do not have a particular geographic requirement, there is usually no need to specify one. A specialist importer can search the appropriate international markets.

13. Product documentation requirements

For an imported or otherwise unfamiliar product, your pharmacy or quality team may require supporting documentation.

Depending on the product, this could include information relating to:

manufacturer;
marketing authorisation;
country of authorisation;
product specification;
storage requirements;
packaging;
labelling;
shelf life; or
supply-chain provenance.

If you know that particular documents will be required before the product can be approved, state this early.

It allows the sourcing team to establish whether the prospective supplier can provide them before significant time is spent progressing the enquiry.

14. Organisation details

A sourcing enquiry should identify the organisation requiring the medicine.

For example:

NHS hospital trust;
private hospital;
community pharmacy;
pharmaceutical wholesaler;
clinic;
healthcare provider; or
another authorised healthcare organisation.

The sourcing team will normally also need a named contact with a work email address and telephone number.

This is particularly important where an enquiry becomes urgent and questions need to be resolved quickly.

15. Any additional constraints

Medicine sourcing often involves requirements that are difficult to capture in a standard form.

Include anything that could determine whether a product is acceptable.

For example:

preservative-free formulation required;
latex-free device required;
specific route of administration;
particular container type;
English-language packaging preferred;
specific excipients must be avoided;
minimum number of doses;
specific brand currently used;
split delivery acceptable;
equivalent presentation can be considered.

These details can prevent the sourcing team from investigating stock that your organisation would ultimately reject.

The five most important pieces of information

If time is limited, provide at least these five things:

1. Medicine

What product do you need?

2. Strength

What exact strength or concentration?

3. Form

Tablet, vial, capsule, solution or another presentation?

4. Quantity

How much do you need?

5. Required-by date

When does it need to arrive?

With these details, a pharmaceutical sourcing team can usually begin investigating the requirement.

Everything else helps narrow the search.

Example of a weak sourcing request

Can you source aztreonam urgently?

There is not enough information here to conduct an efficient search.

The sourcing team would immediately need to ask:

Which strength?
Which formulation?
What quantity?
When is it required?
Is imported unlicensed supply acceptable?

Every additional round of questions costs time.

Example of a strong sourcing request

A much more useful enquiry would be:

Medicine: Aztreonam
Strength: 1 g
Form: Powder for solution for injection
Quantity: 100 vials
Required by: 18 August
Reason: Current UK supply shortage
Supply route: Unlicensed import can be considered
Minimum shelf life: Six months preferred

The sourcing team now has enough information to begin searching appropriate markets immediately.

What happens after a sourcing request is submitted?

Once Alcatia receives a requirement, the first step is to assess the request and investigate the available supply routes.

Depending on the medicine, this might include:

Checking whether licensed UK stock can be identified.
Reviewing alternative supply channels.
Searching international markets.
Identifying suitable manufacturers or products.
Establishing available quantities.
Checking indicative shelf life.
Determining likely lead times.
Reviewing the relevant regulatory route.
Obtaining pricing.
Gathering product information for the customer's assessment.

Where a potential option is identified, Alcatia can provide the relevant information to allow the procurement and pharmacy teams to determine whether the product meets their requirements.

A sourcing request does not itself guarantee supply. Availability can change quickly, particularly during widespread shortages.

Why precise sourcing requests matter during shortages

During a medicine shortage, multiple organisations may be searching for the same stock at the same time.

International quantities can therefore change rapidly.

The time spent clarifying a vague request can matter.

Providing the exact product requirement from the outset means a sourcing team can move more quickly from:

“What exactly do you need?”

to:

“Here are the potential supply options.”

For procurement teams dealing with shortages regularly, establishing a standard internal sourcing request template can therefore make the process significantly more efficient.

What if you do not know all the information?

Submit the enquiry anyway.

You may know that your usual wholesaler cannot supply the product without yet knowing:

whether an alternative manufacturer is acceptable;
whether unlicensed supply can be considered;
which overseas markets have stock; or
what pack sizes may be available.

That should not prevent the search from starting.

Provide everything you know and identify areas where there is flexibility.

A specialist wholesaler can then investigate the potential options and come back with the additional product information your team needs to make a decision.

Need help sourcing a medicine?

Alcatia Pharma works with pharmacy teams, healthcare organisations and pharmaceutical wholesalers to investigate difficult-to-source medicines.

To start a search, tell us:

Medicine
Strength
Form
Quantity
Required-by date

Then add any manufacturer, pack, shelf-life or other requirements that matter to your organisation.

Having difficulty sourcing something?

Tell us what you need and our sourcing team can investigate the available supply options.

This article is intended to provide general information for healthcare procurement and pharmaceutical supply professionals. It does not constitute clinical, legal or regulatory advice. Procurement and use of medicines, including unlicensed medicines, should follow applicable regulatory requirements and the receiving organisation's clinical and governance procedures.

Unlicensed Medicine Imports: A Guide for UK Pharmacy Procurement Teams

Alcatia — Mon, 10 Aug 2026 15:34:40 GMT

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.

Having difficulty sourcing a medicine?

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?

Tell us:

Medicine
Strength
Form
Quantity
Required-by date

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.

How to Source a Medicine During a UK Supply Shortage

Alcatia — Mon, 10 Aug 2026 15:19:35 GMT

Medicine shortages can quickly become a procurement problem.

A product that was routinely available may suddenly be placed on allocation, move to an extended lead time or disappear from the usual wholesale channels altogether. Pharmacy procurement teams then need to establish what stock remains, what alternative routes are available and whether another source of supply can be identified.

In some circumstances, that may include an unlicensed medicine sourced from outside the UK.

The appropriate route will depend on the medicine, the nature of the shortage, the clinical requirement and your organisation's own governance procedures.

If you are currently struggling to source a medicine, Alcatia Pharma can investigate the available supply options on your behalf.

What should you do when a medicine becomes unavailable?

There is rarely a single solution to a medicine shortage.

The first step is to establish exactly what is required and how urgent the requirement is.

This normally means confirming:

Medicine or active ingredient
Strength
Pharmaceutical form
Pack size, where relevant
Quantity required
Required delivery date
Whether existing stock remains locally
Whether the requirement relates to a known UK shortage

From there, pharmacy procurement and clinical teams can determine the most appropriate response.

For NHS organisations in particular, national medicine supply guidance may identify actions such as reviewing available stock, considering clinically appropriate alternatives, using alternative presentations or strengths, or considering unlicensed supply where licensed alternatives are not appropriate.

The main options during a medicine shortage

Depending on the circumstances, procurement teams may consider several routes.

1. Continue sourcing the licensed UK product

Availability can vary between wholesalers and suppliers.

A medicine being unavailable through one usual purchasing route does not necessarily mean that no licensed UK stock remains elsewhere in the supply chain.

It may therefore be possible to identify alternative licensed stock before considering other options.

2. Review alternative strengths, presentations or pack sizes

In some shortages, another presentation of the same medicine remains available.

Whether this represents an appropriate solution is a clinical and pharmacy governance decision, but identifying exactly what alternatives are available can help teams understand their options.

3. Consider an alternative licensed medicine

National shortage guidance may recommend suitable alternatives.

Clinical decisions should always remain with the appropriate healthcare professionals, taking account of national guidance and local policies.

4. Explore mutual aid or alternative supply routes

For hospital pharmacy teams, stock may sometimes be obtained through mutual aid arrangements when normal supply routes cannot meet an urgent requirement. NHS Specialist Pharmacy Service guidance recognises mutual aid as one mechanism that can be used during national shortages, sudden increases in demand and urgent patient requirements.

5. Consider an unlicensed medicine

Where there is a specific clinical need and an appropriate licensed product cannot meet that need, an unlicensed product may sometimes be considered.

This can include a medicine that is licensed and routinely supplied in another country but is not licensed for supply in the UK.

The MHRA regulates the manufacture, import, distribution and supply of these medicines under the UK's provisions for unlicensed medicinal products, commonly referred to as Specials.

What is an unlicensed medicine?

An unlicensed medicine is a medicine supplied without a UK marketing authorisation for the particular product being supplied.

There are several types of unlicensed medicine. During a UK medicine shortage, one relevant route can be an imported unlicensed medicine.

For example, the same active ingredient, strength and pharmaceutical form may be commercially available in another regulated market even though the normal UK product is unavailable.

A specialist importer may be able to identify that stock and arrange supply through the appropriate regulatory process.

However, an imported medicine being available overseas does not automatically mean it is suitable for use in the UK.

The decision to use an unlicensed medicine must follow applicable MHRA requirements, professional guidance and the receiving organisation's own clinical and governance procedures. NHS guidance also notes that imported unlicensed medicines require local assessment as they do not undergo a central UK suitability evaluation for that particular import.

When might unlicensed supply be relevant during a shortage?

Unlicensed supply is not simply an alternative purchasing channel for a licensed product that happens to be difficult to obtain.

MHRA guidance requires a special clinical need for the unlicensed medicine.

In a shortage situation, this can become relevant where the usual licensed medicine cannot be obtained and available licensed alternatives are not appropriate for the patient's clinical requirement.

National Medicine Supply Notifications can specifically identify situations where unlicensed imports may support supply.

For example, in June 2026 a Medicine Supply Notification covering shortages of aztreonam 1g and 2g powder for solution for injection advised clinicians to consider unlicensed products where licensed alternatives were not appropriate.

Alcatia Pharma was named within that notification as one of the specialist importers that had confirmed it could source unlicensed aztreonam.

This illustrates the role specialist importers can play when conventional UK supply routes are unable to meet demand.

How does sourcing an unlicensed medicine work?

The precise process varies according to the product and source market, but from the procurement team's perspective it normally starts with a sourcing enquiry.

Rather than asking your team to search individual international markets, you provide Alcatia with the requirement.

We can then investigate potential sources and establish whether an appropriate supply option can be identified.

This may involve determining:

Whether licensed UK stock can be sourced.
Whether alternative supply channels exist.
Whether the required medicine is commercially available in another market.
What quantities may be available.
Expected lead times.
Product and pack information.
The appropriate regulatory route for the proposed supply.

The MHRA maintains specific requirements governing the import of unlicensed human medicines into the UK.

Any subsequent clinical approval, procurement decision and local assessment remains subject to the customer's own governance processes.

What information does Alcatia need to source a medicine?

The more precise the requirement, the faster we can investigate it.

When submitting a sourcing request, please provide:

Organisation

Tell us which hospital, pharmacy, wholesaler or healthcare organisation is making the enquiry.

Medicine or molecule

Provide the product name or active pharmaceutical ingredient.

If you have a particular manufacturer or brand requirement, include that too.

Strength

For example:

500 mg

rather than simply the product name.

Pharmaceutical form

For example:

Tablets
Capsules
Oral solution
Powder for solution for injection
Pre-filled syringe
Vial
Ampoule

This is particularly important because a shortage may affect one presentation while another remains available.

Quantity required

Tell us your approximate requirement.

Availability can vary considerably depending on whether you require a small number of packs or supply for a larger patient cohort.

Required-by date

This is one of the most important pieces of information.

International sourcing may involve supplier lead times, regulatory processes and transportation, so knowing the required delivery date allows us to assess whether an option is realistically viable.

Is this related to a current shortage?

Let us know whether you are responding to an identified UK supply shortage or another sourcing problem.

If you have the relevant Medicine Supply Notification or shortage reference, you can include this in the enquiry.

Licensed or unlicensed supply

If you know what route you require, tell us.

If you do not know, select unsure.

You do not need to determine the appropriate sourcing route before contacting us. We can investigate the available supply options and provide the relevant product information for your team to assess.

Any additional requirements

This might include:

Specific manufacturer
Country-of-origin requirements
Minimum shelf life
Pack size
Language requirements
Temperature requirements
Previous product supplied
Existing product details

Do not include identifiable patient information in a general sourcing enquiry.

What happens after you submit a sourcing request?

Once Alcatia receives your requirement, our team can begin investigating the available supply routes.

Where we identify a potential source, we can provide the information needed for your procurement team to assess the option.

Depending on the medicine, this may include availability, quantity, manufacturer, source market, pack information, shelf life, pricing and indicative lead time.

For difficult-to-source medicines, availability can change rapidly. Providing a clear requirement and realistic required-by date helps us determine which options are worth pursuing.

How quickly can a medicine be sourced?

There is no universal lead time.

It depends on factors including:

Where stock is located
Whether the medicine is licensed in the UK
Quantity required
Supplier availability
Regulatory requirements
Transport conditions
Customs and import requirements
Required documentation
Whether the medicine requires temperature-controlled transportation

Some enquiries can be resolved through existing supply channels. Others require international sourcing and take longer.

If the requirement is urgent, make this clear when submitting your request.

Do I need to know whether I need an unlicensed medicine?

No.

Your procurement team may know that the normal product is unavailable without yet knowing what alternative supply route is possible.

That is enough to start an enquiry.

Tell us what medicine you need, how much you need and when you need it.

We can investigate the potential sourcing options from there.

Can Alcatia source any medicine?

Not necessarily.

Availability depends on the product, the international market, regulatory requirements and whether an appropriate source can be identified.

For that reason, a sourcing enquiry should not be treated as confirmation that a product is available.

What we can do is investigate the requirement and determine whether we can identify a viable source.

What if the medicine is not on a published shortage list?

You can still submit an enquiry.

Supply difficulties do not always begin with a national shortage notification. Procurement teams may encounter local availability problems, wholesaler allocations, manufacturer delays or requirements for medicines that are not routinely marketed in the UK.

If your usual supply route cannot meet the requirement, send us the details and we can determine whether we may be able to help.

Need help sourcing a medicine?

If your usual supply route has failed, Alcatia Pharma can investigate the available options.

Tell us:

What medicine you need.
What strength and form you require.
How much you need.
When you need it.

Our sourcing team can take it from there.

Having difficulty sourcing something?

Provide the details of your requirement and our team will investigate the available supply options.

This article is intended to provide general information for healthcare procurement and supply professionals. It does not constitute clinical, prescribing or regulatory advice. Decisions regarding the prescribing, procurement and use of unlicensed medicines should be made by appropriately authorised professionals in accordance with current MHRA guidance, professional standards and applicable local governance procedures.