Using our reclassification guidance

Before starting an application, review this guidance page and the supporting documents: MHRA guidance on the reclassification of medicines in the UK, the supporting flow diagram and the validation checklist.

Further explanation is also available in the webinar recording, November 2024 MHRA Reclassification process for medicines in the UK

Overview

The legal classification of a pack of medicine determines the level of control over its supply. In part, classification rests on how much health professional input is needed to diagnose and treat the conditions for which the medicine might be used. Currently, there are 3 categories of medicine classification:

prescription-only medicine (POM)
pharmacy medicine (P)
general sales list medicines (GSL)

The fundamental principle guiding the classification of medicines is to optimise timely access to effective treatments while reducing the risk of harm from improper use.

Making medicines available over the counter: the trade-offs

Benefits	Barriers
Quick relief of the disorder	Potentially troublesome or serious side effects
Individual can exercise greater autonomy and choice	Possibility of misdiagnosis and delay in correct treatment
Rapid and convenient access to medicines	Potential for harm from incorrect use

Classifications of medicines

The three legal categories are explained here, with examples of medicines in each of the categories. It also explains how the categories relate to the term over-the-counter (OTC) medicines.

Prescription-only medicines

Medicines classified as ‘prescription only’ can only be obtained with a valid prescription issued by an authorised health professional. The prescription needs to be taken to a pharmacy where the medicine is prepared under the supervision of a pharmacist. Sometimes the prescription is filled at a dispensing doctor’s surgery. A member of the public cannot buy a prescription-only medicine (POM).

A rectangular box enclosing the letters POM appears on the packs of prescription-only medicines.

In general, POMs are for conditions that are best diagnosed and managed by health professionals. Examples of prescription-only medicines include antibiotics and medicines for treating epilepsy.

Pharmacy medicines

People can buy products classified as ‘pharmacy medicines’ (P) but only from a pharmacy and in the presence of a pharmacist. These medicines, also called ‘pharmacy-only medicines’, are not usually displayed on open shelves. A rectangular box enclosing the letter P appears on the packaging of pharmacy medicines.

Pharmacy medicine packs are generally for short-term treatment of medical conditions that can be readily identified and are not likely to persist, although they may sometimes be available for the management of long-term conditions. Pharmacy medicines need to be used more carefully than medicines sold in other retail outlets and people may require special advice on treatment.

Pharmacy staff may discuss with the purchaser how to use the medicine, ask questions to make sure that the chosen medicine is appropriate, and check if the person needs to see another health professional such as a doctor.

The pack generally includes advice to see a health professional if the condition does not improve or gets worse or, in the case of long-term conditions, if a doctor has not been consulted for some time.

Compared to the packs available in retail outlets, medicines like ibuprofen and paracetamol can be bought in larger packs under a pharmacist’s supervision. But there may still be a limit on how much pharmacy medicine a person can buy. This helps prevent inappropriate and possibly harmful long-term use and reduces delay in diagnosing a condition that requires different treatment. Other examples of pharmacy medicines include tablets for emergency contraception and medicines for erectile dysfunction.

General sales list medicines

People can buy general sales list medicines from retail outlets such as corner shops and supermarkets. The medicines are also available for self-selection in pharmacies. General sales list medicines are taken for common, easily recognised ailments which usually last around 2 to 3 days. These medicines cause few troublesome side effects in normal use.

To reduce the chances of harm from inappropriate use, many general sales list medicines contain only a few doses, and they often carry advice to get help from a health professional if the ailment does not improve or gets worse.

A general sales list medicine may be recommended for treating a limited range of conditions, while the same medicine can be used for a wider range of conditions when it is sold as a pharmacy medicine, and an even wider range of conditions when supplied on prescription.

Prescription-only medicines and pharmacy medicines can be used at higher doses and for longer duration than general sales list medicines. Also, general sales list medicines may be used for only certain groups of people; for example, they may not be recommended for use by children or during pregnancy.

Examples of general sales list medicines include small packs of painkillers, and of antihistamines for hay fever and other allergies.

Over-the-counter medicines

‘Over-the-counter (OTC) medicines’ covers all general sales list medicines and pharmacy medicines. The description conveniently distinguishes medicines that can be bought from those that must be prescribed. The term ‘over the counter medicines’ is informal and is not used in the UK medicines regulations.

Changing the legal classification of a medicine

The legal classification of a medicine may sometimes change, we call this reclassification. It is also sometimes called ‘switching’. Growing confidence in the medicine’s action and improved understanding of its side effects can lead to a change in classification.

Prescription-only medicine (POM) to pharmacy medicine (P)

If a medicine meets the criteria for prescription control set out below, it cannot be reclassified.

Prescription only status applies where:

a direct or indirect danger exists to human health, even when used correctly, if used without medical supervision
there is frequently incorrect use which could lead to direct or indirect danger to human health
further investigation of activity and/or side-effects is required
the product is normally prescribed for parenteral administration (by injection)

In the UK these criteria are laid down in the Human Medicines Regulations 2012, regulation 62(3).

Pharmacy medicine (P) to general sales list medicine (GSL)

Under the provisions of The Human Medicines Regulations 2012, regulation 62(5), GSL is appropriate for medicines which can, with reasonable safety, be sold or supplied otherwise than by or under the supervision of a pharmacist.

The term “with reasonable safety” is defined as: “where the hazard to health, the risk of misuse, or the need to take special precautions in handling is small and where wider sale would be a convenience to the purchaser.”

Reclassification may involve:

introduction of one or more additional legal status for a particular medicine (for example, a POM may additionally be classified into a P or GSL medicine category - in such a case, the quantity, dose and the conditions the medicine is used for may be restricted when it is supplied in the new categories compared to the original prescription-only category)
switching over entirely from one classification to another (for example, all packs of a P medicine could be changed to the GSL category - in this case, the previous pharmacy medicine category would no longer apply to that medicine)

Evidence to support the classification change

A proposal to change a medicine’s classification needs to be supported by good evidence that focuses on the risk to the public on changing the classification.

The evidence may include:

clinical studies
extensive clinical use indicating acceptable level of side effects
advice of experts
views of relevant health professionals and their professional bodies
views of relevant public associations and individuals with an interest in the medicine under consideration

The evidence needs to demonstrate that the risk to the public will be adequately managed.

Procedure for requesting a classification change

The MHRA procedure is straightforward and quick if a classification change concerns a medicine very similar to one that has already been processed. The application is dealt with simply by reference to the medicine already reclassified. This is called a simple reclassification.

However, a more detailed stepwise procedure applies if the classification request breaks new grounds, for example if it is for: - a type of medicine that has never had a classification change - a condition that was not previously considered during a classification change

This is called a major reclassification.

If you are applying for a medicine to be classified either as a pharmacy medicine or a general sales list medicine, you should first collect evidence that it is likely to be used appropriately and with relatively little danger to the public.

We encourage you to ask for scientific advice from the MHRA on how to apply for a classification change and what evidence you need to submit.

We will assess the application once it has been submitted formally. Depending on the nature of the proposed classification, we might also: - take advice from our committees of external experts - consult a ‘stakeholder group’ comprising healthcare professionals and representatives of people affected by the classification change - run a public consultation

We will tell you the outcome of the reclassification application and give reasons for the decision.

On rare occasions, after thorough consideration by expert committees, we may decide that public health is best protected by removing over-the-counter availability of a medicine. In other words, reclassifying it from GSL or P to POM. In these cases, we will work closely with affected companies to make the necessary changes.

Types of reclassification procedure

There are different types of reclassification procedure depending on your reclassification proposal.

Simple reclassification

A simple application is based on an analogous product which has already been reclassified. An analogous product is a medicinal product which has a marketing authorisation, can be marketed in the UK and meets the following criteria:

it has the same active ingredient, route of administration and use
it has the same strength or a higher strength
it has the same dosage or daily dosage, or a higher dosage or daily dosage
it is for sale or supply at the same quantity or a greater quantity as the medicinal product in relation to which the application is made

The analogous product should have been on the market during the previous 6 months and must not have been removed for reasons of safety, quality, or efficacy.

Exceptionally, it may be possible to accept certain products which have not been on the UK market for over 6 months as analogous products. Contact the MHRA (variationqueries@mhra.gov.uk) for guidance on the eligibility of these products. In these circumstances, acceptance of the proposed analogous product will be on a case-by-case basis.

You should apply for simple reclassification as a type IB or type II (analogous product) variation. The timetable follows the normal timetable detailed in the link. The variation application should include details of the analogous product.

Major reclassification

A reclassification is major if, for example, it is the first in a new therapeutic category or a new target population for an existing product. We must refer major reclassifications to an expert committee.

If a major reclassification does not need to be referred to an expert committee, it will be downgraded to a standard application.

The reclassification application should include:

product information - summary of product characteristics (SmPC), labelling and patient information leaflet (PIL)
a clinical overview demonstrating that the criteria are met for reclassification
a risk management plan (RMP) outlining the important risks associated with the reclassification of the product and the plans to manage these risks

All applications that are not for an analogous product should be submitted as major. We will downgrade them to standard, if required, during the assessment process.

For a full list of documents that you must submit as part of a simple or major reclassification application, see the Reclassification validation checklist.

Public and professional input

We are committed to widening access to medicines for the benefit of public health when it is safe to do so. In addition to safety considerations, an important factor in the reclassification process is focusing on issues that matter to patients and health professionals. In order to understand those issues, where appropriate, we run stakeholder groups and public consultations.

Stakeholder engagement

We meet with stakeholders on an ad-hoc basis to get their views on medicines that could be reclassified. Each stakeholder group consists of representatives from the public and health professionals who will discuss the possible reclassification of a specific POM to a P or a P to a GSL medicine. These meetings take place in the early stages of processing a reclassification application. We consider the views from the group (lay and expert) as part of the reclassification assessment.

Public consultations

We also run 21-day public consultations for some medicines that are being reclassified. These are published on the consultations page when available. These consultations seek the public’s views on the reclassification of a specific medicine.

Public consultations usually take place in the later stages of a reclassification assessment, after the MHRA assessors have considered the application and sought independent advice from the Commission on Human Medicines (CHM).

Additional information

Reclassification guidance and annexes (PDF, 297 KB, 22 pages)

Reclassification validation checklist

Flow diagram for major reclassification applications

MHRA guideline for the naming of medicinal products and Braille requirements for name on label

MHRA reclassification fees

MHRA guidance on the application for exclusivity for change in legal status of a medicine

Webinar recording

Watch the video recording of the MHRA reclassification process for medicines in the UK, which took place In November 2024.

MHRA Reclassification process for medicines in the UK

Legal status of substances

The Table of approved reclassifications from 1991-2026 (MS Excel Spreadsheet, 39.1 KB) contains the information on UK medicines reclassified from POM to P, and P to GSL medicine from 1991 to 01 March 2026. The list will be updated every six months. From 1991 to 2015 only the first reclassification of a substance is included (further extensions such as wider indications, additional pack sizes or higher strengths are not included). From 2016 all major and standard reclassifications are included. Reclassifications based on an analogous product (‘simple applications’) are not included.

You can get details on the legal status, pack size, strength, formulation or other details for a specific product or active substance from info@mhra.gov.uk.

Contact

Email variationqueries@mhra.gov.uk with any queries.

Medicines: reclassify your product