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:

1. identify potential overseas products;
2. obtain supplier and product information;
3. conduct the necessary local assessment;
4. complete regulatory requirements; and
5. 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.