Reclassification

What is reclassification?

Reclassification is the process of changing the legal status of a medicine. It is also referred to as “switching”.

When data shows that a medicine can be used appropriately and effectively without intervention from a doctor, its legal status can be changed via reclassification. This makes it available over-the-counter without a prescription, empowering patients to self-care and alleviating demand for NHS services.

In the UK the legal classification of a medicine determines the level of control over its supply.

Categories of medicines

There are three categories that a medicine can be classified within:

Prescription-Only Medicine (POM) – which has to be prescribed by a doctor or other authorised healthcare professional and must be dispensed from a pharmacy or another specifically licensed place
Pharmacy (P) – which can be bought only under a pharmacist’s supervision within a pharmacy
General Sales List (GSL) – which can be bought from retail stores, such as newsagents, supermarkets or vending machines in a shop

P and GSL medicines are collectively known as over-the-counter (OTC) medicines.

Types of reclassification

The underlying principle for classifying medicines is to maximise timely access to effective medicines, while minimising the risk of harm from inappropriate use.

As such, all new medicines or new combination products are initially granted a POM licence. Overtime, growing confidence of the medicine’s role and improved understanding of its side effects can lead to a change in classification – known as ‘reclassification’ or ‘switching’.

Reclassification may involve three types of switches:

Prescription-Only Medicines to Pharmacy
Pharmacy to General Sales List
Prescription-Only Medicines to General Sales List

How does reclassification help patients and the NHS?

By making a medicine available OTC, there are a number of benefits to an individual looking to self-care:

People can have rapid and convenient access to medicines
Exercise more autonomy and choice
Quickly relieve their ailments

Pharmacies have longer hours than GP surgeries and are often open at the weekends. Furthermore, over 99% of those living in areas of the highest deprivation are within a 20-minute walk of a community pharmacy,^[1] making the medicines available at pharmacies an accessible resource for people with health concerns.

For the system more broadly, a greater availability of OTC medicines means:

Fewer GP visits
Fewer A&E interactions
Prevention of worsening of conditions

[1] https://selfcarestrategy.org/wp-content/uploads/2021/10/Realising-the-potential-developing-a-blueprint-for-a-self-care-strategy-for-England-WEB-VERSION_final.pdf

Statistics from our report on the Economic Impact of Over-The-Counter Products in the UK

96% of people in the UK

have at least one self treatable condition annually

Statistics from our report on the Economic Impact of Over-The-Counter Products in the UK

43% of people in the UK

have four or more self treatable conditions annually

Statistics from our report on the Economic Impact of Over-The-Counter Products in the UK

There’s potential to save the NHS £1.4 bn per year

by switching 5% of prescription-only medicines to OTC

Our work on reclassification

Developed a proposal to reinvigorate reclassification to support industry in making more reclassification applications

In 2023 we kicked off our work to activate a new Reclassification Alliance and widen access to more OTC medicines. PAGB successfully coordinated the reestablishment of the Reclassification Alliance, in collaboration with the MHRA and DHSC—the first meeting taking place in September 2023

Our work continued across 2024, ensuring this was front and centre as a priority for the new government following the election. In September 2024, we published our State of the Nation report exploring the current state of self-care and OTC medicines, with the aim to support the government by setting out key policy recommendations to action as part of their planning to build an NHS fit for the future.

This included recommendations to: work with the Reclassification Alliance to explore opportunities to widen the use of 25 OTC products over 5 years; work with the MHRA to re-evaluate the restrictive criteria for switching a POM to OTC to allow timely access to effective treatments (e.g. injectables to treat life-threatening allergic reactions); and put in place policies to incentivise the OTC sector to reclassify their products in the UK.

Working with government to maintain momentum on self-care

In February 2025, after many months of work to progress reclassification, the Department of Health and Social Care (DHSC) issued a list of medical conditions and categories where it is encouraging more reclassification applications to the Medicines and Healthcare products Regulatory Agency (MHRA). The work to identify these new conditions and categories suitable for reclassification has been driven by the Reclassification Alliance

PAGB’s CEO, Michelle Riddalls OBE, chaired the Conditions and Categories Working Group, collaborating with key pharmacy and industry bodies to explore suitable categories where medicines could be reclassified to widen access treatments for certain conditions and indications.

PAGB is now focused on ensuring that self-care remains a political priority and that self-care policies are incorporated into the 10 Year Health Plan, Industrial Strategy and Life Sciences Sector Plan.

Actively engaging with MPs and stakeholders

With the election of new MPs in July 2024, we worked on sending tailored emails to engage with ministers on self-care and reclassification, highlighting the opportunities and savings to the NHS.

In the last year, we have also written two letters, in collaboration with the pharmacy associations involved in the Conditions and Categories Working Group, to MPs to discuss all areas of reclassification, as well as sharing briefings with officials in the Treasury on the economic impact of the OTC sector. Additionally, we have been sharing our State of the Nation report with government stakeholders and across our parliamentary engagement which clearly defines our reclassification asks, with ongoing outreach.

PAGB has also been liaising with the Office for Life Sciences to build on their support for this area of growth and have received their commitment to connect with DHSC to progress the work.

Engaging with our members

We support our members through our active Reclassification Working Group which feeds into regulatory policy and activities with MHRA and includes developing process proposals to share with MHRA. We keep the group up to date with the ongoing collaborations with MHRA, DHSC and the output from the Reclassification Alliance.

We have produced reclassification guidance PAGB Members, and, since 2023, we also run workshop events twice a year for members which complements our guidance with information on how to identify a reclassification candidate and prepare for the early stages of the reclassification procedure.

Our members can also benefit from bespoke advice pre, during and post reclassification submissions and assessment, as well as advertising advice and support for new launch campaigns.

Wider international support

At an international level and as part of our strategy, our work includes providing overviews and support to other trade associations and/or countries and providing advice to companies outside of the UK at times via consultancy work.

In 2023, our international support focused on Sweden and Brazil. More recently in 2025, we met with an Andean delegation from Colombia, Peru, and Ecuador hosting their health ministries and heads of regulatory bodies to exchange best practices, touching on reclassification and with a specific focus on umbrella branding.

Member briefing on Reclassification

PAGB members can read our briefing – ’40 years on: setting a new ambition for reclassification’ here.

Find out more

Watch our video: PAGB – the expert voice on reclassification

Key milestones for reclassification

February 2025: DHSC announce new opportunities to reclassify medicines, borne out of Conditions and Categories Working Group recommendations.

July 2024: Labour wins General Election – PAGB rolls out a sustained and targeted outreach programme to engage MPs with reclassification proposals.

April 2024: Michelle Riddalls participates in panel discussion with Wes Streeting MP (now Secretary of State for Health and Social Care) and highlights importance of self-care and access to OTC medicines.

December 2023: We hosted a celebratory event to mark the 40-year anniversary of reclassification in the UK. We also attended meetings on Categories and Conditions and a processes workshop with MHRA.

November 2023: PAGB kicked off the Categories and Conditions work for the Reclassification Alliance, and shared input into other DHSC and MHRA-led workstreams, as well as liaising with members.

September 2023: Marked the inaugural meeting of the Reclassification Alliance.

June 2023: We attended a meeting with No.10 with the DHSC and MHRA to discuss the implementation of the Primary Care Recovery Plan.

May 2023: Reclassification was included in the Delivery plan for recovering access to primary care (Primary Care Recovery Plan) – a huge win for PAGB, our partners, and the public.

January 2023: We launched guidance for members on reclassification.

Self-care

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