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?
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:
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.
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:
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 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.
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.
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:
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.
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:
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.
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.
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.
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:
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.
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:
Depending on the product, procurement and quality teams may therefore need information such as:
The precise assessment will depend on the medicine and the organisation's local governance procedures.
Yes.
Two medicines can contain the same active ingredient and strength without being identical products.
Differences may include:
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.
When faced with a difficult sourcing requirement, it is useful to separate two questions.
This is determined by the appropriate clinical, prescribing and pharmacy governance teams.
This is where procurement teams and specialist sourcing partners can help.
The sourcing process can establish:
The clinical team can then assess available options with much better information.
Whether you require licensed or unlicensed supply, providing a precise requirement will make the search substantially more effective.
Alcatia recommends including:
Give the exact product or molecule required.
For example:
500 mg
rather than only the medicine name.
For example:
Give the approximate number of packs, vials, units or doses required.
This helps determine which sourcing routes are realistically viable.
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.
Where relevant, include:
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.
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.
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.