Guidance

Ensuring the efficient supply and distribution of medicine to patients: best practice guidance

Updated 5 August 2026

Introduction

Supply chains for human medicines, including their active substance and excipient ingredients, are increasingly complex and global. Early detection and reporting of any issue that could lead to a medicine supply shortage is more important than ever. This is because it maximises the time for government, working closely with health system and industry partners, to put mitigations in place and minimise patient impact.

All parts of the supply chain must continue to work together to help ensure that patients receive the medicines they need when they need them. Not receiving a much-needed medicine can be a great source of distress to patients and their carers, and in some cases can cause pain or deterioration in a patient’s condition. Reliable medicine supply is essential to patient trust in the UK’s healthcare system as well as the reputation of the pharmaceutical industry.

The Department of Health and Social Care (DHSC) committed to revise this guidance in its recent publication Managing a robust and resilient supply of medicines, as significant changes have taken place in the operational environment since this guidance was first published in 2013.

We have developed the current guidance following detailed consideration of past and recent issues related to medicine supply, in collaboration with a stakeholder group representing different parts of the supply chain. The primary purpose of this document is to provide accessible guidance on what the different parts of the medicine supply and distribution system can do to minimise the likelihood of interruptions to the supply of medicines, and to enable continuous improvement.

By giving an overview of what each participant should be doing, the guidance is intended to be a useful point of reference for establishing expectations of marketing authorisation holders (MAHs)^{[footnote 1]}, wholesalers and purchasers of medicines in both community and hospital pharmacies and others in the pharmaceutical supply chain. Following the guidelines will help the medicines supply system to work effectively and help to ensure that patients have access to the medicines they need.

This does not replace separate guidance on reporting, shortage management and the legal duties on pharmaceutical suppliers and wholesalers licensed to trade in the UK. See the Medicines supply management page for comprehensive guidance and resources on this.

If you have an nhs.net email address, you can register for the Medicine Supply Tool on the Specialist Pharmacy Service (SPS) website. This provides up-to-date information for healthcare professionals about medicine supply issues. See also NHS England’s guide to the systems and processes for managing medicines supply issues in England.

This guidance has been co-produced by representatives from each part of the supply chain, including:

• Association of the British Pharmaceutical Industry (ABPI)
• Company Chemists Association (CCA)
• Community Pharmacy England (CPE)
• Healthcare Distribution Association (HDA)
• Independent Pharmacies Association (IPA)
• Medicines UK (MUK)
• NHS England
• National Pharmacy Association (NPA)
• Proprietary Association of Great Britain (PAGB)
• Department of Health and Social Care (DHSC)

The document has also been endorsed by: 

• British Medical Association (BMA)
• Dispensing Doctors Association (DDA)
• Ethical Medicines Industry Group (EMIG)
• Medicines and Healthcare products Regulatory Agency (MHRA)
• Royal College of Pharmacy (RCP)

These organisations have committed to review this document every 2 years.

The following sections outline the distinct areas of responsibility and best practice for each of the 3 different parts of the supply and distribution chain:

• MAHs
• wholesalers
• procurers

Marketing authorisation holders

As a condition of their licences, MAHs are required to take all reasonable steps to ensure that their medicines are continuously available to meet patient need in the UK. They should:

• ensure reliable sourcing of raw materials, including active pharmaceutical ingredients, excipients and packaging materials, that support the production and supply of finished form medicines to meet predicted demand on time
• ensure that agreements with suppliers are regularly monitored for effectiveness, including supply issue reporting requirements that insist upon early detection and reporting of potential issues
• ensure the robustness of their supply chains, either through having sufficiently diverse options for securing source materials or other suitable measures to minimise the impact of an interruption of supply
• maintain sufficient stock to ensure the ability to respond to demand fluctuations within a reasonable range

This list is not exhaustive but shows the main responsibilities of MAHs.

To fulfil the above responsibilities, MAHs should:

Ensure reliable supply to their customers

MAHs are responsible for having available stock that is ready for release to the market. The stock can then be delivered to MAHs’ customers in an efficient and timely way, with supply agreements in place with verified purchasers. To support this, MAHs should regularly review their delivery arrangements to ensure they are fit for purpose.

Ensure reliable supply from their suppliers

MAHs should have full oversight of their supply chains and are expected to monitor the supply and demand situation of medicinal products. This will include receiving, analysing and responding to any information from their manufacturers and suppliers as part of forecasting to match supply with demand.

While some supply interruptions may unavoidably provide little prior notice and/or be outside MAHs’ ability to quickly respond, agreements should be in place to ensure that their suppliers report any material issue in sourcing material or delivering on time to the MAH in time to mitigate the impact of this.

To reduce the risk of shortages occurring, as part of their business continuity plans MAHs should have risk mitigation plans in place with suppliers to manage critical vulnerabilities, which may include contingency around alternative stock ordering or routing options.

Report any potential issue as soon as it is detected

MAHs must report any potential issue or discontinuation of supply as early as possible, and, for products to be supplied to the NHS, 6 months in advance or as soon as practicable after an issue has been identified. This is a legal requirement under the Human Medicines Regulations 2012 and in line with the Health Service Products (Provision and Disclosure of Information) Regulations 2018.

The manufacturer should report any potential issue or discontinuation using DHSC’s discontinuations and shortages (DaSH) portal (sign-in required).

Ensure product changes for medicines supplied to the NHS are updated on the NHS dictionary of medicines and devices

Product changes to branded or generic and/or non-proprietary medicines for supply to the NHS (discontinuation, pack sizes, pricing, product launch, and so on) should be updated on the NHS dictionary of medicines and devices.

It is best practice to submit and update your data at least 10 working days before its effective date, launch date or date of change. If a member of the voluntary scheme for branded medicines pricing, access and growth (VPAG) or a member of the statutory scheme does not have access to the in-demand system, they must notify the NHS Business Services Authority (NHSBSA) of the product launch by emailing pprs@nhsbsa.nhs.uk. They should include details of the:

• brand name
• agreed NHS list price
• strength
• pack sizes
• effective date of launch
• summary of product characteristics

Ensure all MPSC framework terms and conditions are adhered to

Where an MAH product is being supplied under an NHS England medicines procurement and supply chain (MPSC) framework they must ensure that all terms and conditions are adhered to. This includes holding an agreed buffer stock of that product.

Report material changes in supply and demand to wholesalers quickly

Report any material changes in supply and demand to wholesalers as soon as possible, within the constraints of competition rules. MAHs may only have a partial view of the overall demand for each distinct product, so it is important that the material information goes to the wholesalers to support early adjustments to supplies.

Maintain good communication with wholesalers

Schedule regular communication, preferably with a named contact, to ensure both parties have a good understanding of supply and demand for particular products so that patients receive the medicines they need.

Manage the use of quota allocations appropriately

MAHs should manage the use of quota allocations fairly, and put in place a clear quota review process for when usage or demand changes. They should also provide training to staff who are responsible for managing stock allocations.

Any prescription verification processes should be compliant with General Data Protection Regulation (GDPR) requirements.

Wholesalers

This section outlines the responsibilities for licensed pre-wholesalers and full line and short line wholesalers, who have a critical role in working with pharmaceutical suppliers to ensure efficient and timely supply of medicines to patient-facing services.

Wholesalers play an important part in the supply and distribution chains and can often be the first to identify changes in demand. They should take responsibility for:

• ensuring fair and equitable access to medicines across customers and avoiding geographical disparities where possible
• sharing information on demand increases or supply decreases with MAHs which can support early detection and adjustment of supplies

To fulfil these responsibilities, wholesalers should:

Communicate demand and supply changes

As the link between MAHs and patient-facing services, wholesalers will often be the first to notice changes in supply and demand. It is therefore important that they report any changes in supply and demand to MAHs as soon as possible, within the constraints of competition rules. They may only have a partial view of the overall demand for each distinct product, so it is important that the material information goes to the MAHs to support early adjustments to supplies.

Support equitable access to medicines

Wholesalers can centrally co-ordinate deliveries for their customers in primary care and secondary care, and they should try to ensure fair access to medicines, especially during shortages. During a period of nationally declared shortage, wholesalers should expect to receive support and guidance from DHSC and/or the relevant NHS authority.

In secondary care, manufacturers contracted to supply medicines to one NHS region will often be able to meet demand following a shortage from another supplier in another region. In these cases, the manufacturer, wholesaler and NHS England should consult and agree best use of remaining stock. 

If wholesalers suspect hoarding of medicines that are on the restricted medicines list this should be reported to DHSC for potential investigation - see the guidance Export and hoarding of restricted medicines. Wholesalers should also not hoard, recognising that at times wholesalers may hold buffer stocks to ensure continuity of supply.

Ensure good communication with MAHs

Wholesalers should schedule regular communication with MAHs - preferably with a named contact - to ensure both parties have a good understanding of supply and demand for particular products. This helps to ensure that patients receive the medicines they need.

Manage the use of quota allocations appropriately

Wholesalers should manage quote allocations fairly, and put in place a clear quota review process for when usage or demand changes. They should also provide training to staff who are responsible for managing stock allocations. Any prescription verification processes should be compliant with GDPR requirements.

Ensure databases and portals are up-to-date and maintain good communications with customers

Information should be clear and accurate, and messages based on the available information provided by the MAHs.

Use multiple suppliers for high volume or vulnerable products

Where possible, wholesalers should use multiple suppliers for high volume products and products vulnerable to supply disruption.

Comply with the Health Service Products (Provision and Disclosure of Information) Regulations 2018

Wholesalers must comply with the Health Service Products (Provision and Disclosure of Information) Regulations 2018, ensuring that all sales and/or volume data requests made under the regulations are responded to in a timely manner.

Procurers

This section includes responsibilities for those who procure medicines to be used in treating NHS patients in primary and secondary care. Procurers, including community pharmacies, dispensing doctors and secondary care trust pharmacies, should ensure:

• that their typical patient or customer base is served by taking appropriate steps to make enough medicine available to fulfil patient need
• local level resilience by co-ordinating with each other and, where appropriate, with their local integrated care board (ICB), and maintaining alternative sources of medicines when possible so that patients can access medicines in their local area
• that in times of nationally declared shortage:
  • national guidance and, where applicable, local guidance are implemented in a timely manner
  • where a serious shortage protocol (SSP) is in place, consideration must be given as to whether a supply can be made in accordance with the SSP and if so, supply should be made in strict accordance with the protocol

To fulfil these responsibilities, procurers should:

Assess and supply for local demand

To support continued supply, hospital pharmacies, community pharmacies and dispensing doctors’ practices should take reasonable steps to monitor and meet local demand changes.

Strengthen local supply resilience

In secondary care, for medicines only prescribed in hospitals, suppliers will often be contracted to supply to a particular region. If that supplier has a shortage of a medicine, in some circumstances suppliers who are contracted to supply to other regions may be permitted to support meeting out of region need. If doing so could lead to them failing to meet their contractual obligations in the region they are contracted to supply, they should seek permission from NHS SPS procurement specialists.

For secondary care medicines that are available in primary care, regional procurement teams can explore whether they can safely use stock that has not been set aside for the purposes of meeting the requirements of secondary care contracts without causing a negative impact on the ability of suppliers to meet the needs of community pharmacies and dispensing doctors.

Stay informed

Procurers should ensure they are aware of all communications issued on shortages or discontinuations of medicines including:

• national patient safety alerts
• medicines supply notifications
• SSPs

All communications, including those relating to lower impact shortages, can be found on the medicines supply tool web page.

The NHSBSA also publishes all SSPs on its website. Printable medicines shortages leaflets and posters setting out actions that should be taken by pharmacists, prescribers and patients when there is a national shortage of a medicine can also be downloaded from the SPS website.

In primary care, community pharmacies have a vital role in ensuring patients have timely access to treatment and should dispense in line with their NHS terms of service.

Where a pharmacy is unable to supply a particular medicine promptly, and an SSP is not in place to enable them to offer the patient an alternative, they should discuss with the patient the possible options available to them, which can include: 

• offering to contact the patient’s prescriber to jointly consider whether another suitable brand or medicine is available
• checking whether the medicine is available at another pharmacy

Other factors that procurers should take into account:

Digital trading platforms

If used, digital trading platforms should be deployed in such a way that they support pharmacies to source and dispense medicines with reasonable promptness.

Avoid hoarding

At all points in the supply chain, and at all times, hoarding or intentionally over-buying products should actively be avoided.

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1. An MAH is a company or organisation responsible for ensuring that a medicine meets the necessary standards for safety, effectiveness and quality before it can be sold within a specific region. The pharmaceutical MAH will be the official entity licensed to supply the medicine by MHRA for the UK. ↩