Medicines: reclassify your product

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 3three categories ofthat a medicine classification:can be classified within:

• prescription-onlyPrescription-Only medicineMedicine (POM)(POM) - must be prescribed by a doctor or other authorised health professional and must be dispensed from a pharmacy or from another specifically licensed premises
• pharmacyPharmacy medicineMedicine (P)(P) - can be bought only from pharmacies and under a pharmacist’s supervision
• generalGeneral salesSales listList medicinesMedicines (GSL)(GSL) - may be purchased without the supervision of a pharmacist and are available in retail outlets, such as a newsagent, a supermarket, or a vending machine in a shop

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 overover-the-counter: 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 exclusively obtained withagainst 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).(POM).

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

In general, POMsprescription-only medicines are used 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)(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 appearsletter P appears on the packaging of pharmacy medicines.

Pharmacy medicine packs are generally for short-termshort 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 tothe usemedicine theis medicine,to be used, 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 22–3 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,conditions whilewhereas the same medicine can be used for a wider range of conditions when it is sold as a pharmacy medicine,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)(POM) to pharmacy medicine (P)

(P)

IfA a medicine meetswill be non-prescription unless it fulfils the criteria for prescription control as set out below, it cannot be reclassified.below.

Prescription only status applieswill apply 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 medicineMedicine (P)(P) to generalGeneral salesSales listList medicineMedicine (GSL)

(GSL)

Under the provisions of The Human Medicines Regulations 2012, regulation 62(5), GSL is62(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” ishas been 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 medicinemedicine. (forFor example, a POMprescription-only medicine may additionally be classified into a P orpharmacy GSL medicine category -or ina general sales list medicine category. In such a case, the quantity, dose and the conditions for which the medicine is used for may be restricted when it is supplied inwithin the new categories compared to the original prescription-only category)category.
• switching over entirely from one classification to anotheranother. (forFor example,instance, all packs of a Ppharmacy medicine category could be changed to the GSLgeneral categorysale -list inmedicine category. In this case, the previous pharmacy medicine category would no longer apply to that medicine)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: -comprise clinical studies -studies, extensive clinical use indicating acceptable level of side effects -effects, advice of experts -experts, views of relevant health professionals and their professional bodies -bodies, as well as the views of relevant public associations and individuals with an interest in the medicine under consideration

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

Procedure for requesting a classification change

At the MHRA, we have set out a 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: -for a type of medicine that has never hadundergone a classification change - or if it is for a condition that was not previously considered during a classification change

change. This is called a major reclassification.

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

WeCompanies encourageare youencouraged to ask for scientific advice from the MHRAthe MHRA on on how to apply for a classification change and what evidence youneeds need to submit.

Webe will assesssubmitted. The MHRA assesses the application once it has been submitted formally. Depending on the nature of the proposed classification, wethe MHRA might mightalso also: - take advice from ourits committees of external experts -experts, consult a ‘stakeholdergroup, group’(‘stakeholder group’), comprising healthcare professionals and representatives of people affected by the classification change - and run a public consultationconsultation.

We willThe MHRA will tell youthe requesting organisation the outcome of the reclassification application and it will give reasons for the decision.

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

Types of reclassification procedure

There are different types of reclassification procedure depending on yourthe company’s reclassification proposal.

Simple reclassification

A simple‘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 and
• 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 6six 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. ContactApplicants are advised to contact the MHRA (variationqueries@mhra.gov.uk) forto seek guidance on the eligibility of these products. In these circumstances, acceptance of the proposed analogous product will be determined on a case-by-case basis.

YouA shouldsimple applyreclassification forshould simplebe reclassificationmade as a type IB or type II (analogous product) variation., Theand the timetable follows the normal timetable detailed in the link. The variation application should include details of the analogous product.

Major reclassificationreclassifications

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. WeMajor reclassifications must referbe majorreferred 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‘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 thatwhich are not for an analogous product should be submitted as major.major, Weand these will downgradebe themdowngraded to standard, if required,required during the assessment process.

For a full list of documents thatwhich you must submitbe submitted as part of a simple or major reclassification application,application please see the Reclassification validation checklist. (MS Word Document, 35.5 KB)

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, ana importantkey 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-hocad 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 POMPrescription-Only Medicine to a PPharmacy Medicine or a PPharmacy Medicine to a GSLGeneral medicine.Sales List Medicine. These meetings takeare placeheld in the early stages of processing a reclassification application.application Weand consider the views from the group (lay and expert) are considered by the MHRA as part of the reclassification assessment.

Public consultations

We also run 21-day public consultations for some medicines that are being reclassified.reclassified, Theseand 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 are usually takeheld place in the later stages of a reclassification assessment, after the MHRAapplication assessorshas havebeen considered by the applicationMHRA assessors and sought independent advice has been sought from the Commission on Human Medicines (CHM).

Additional information

Reclassification guidance

Reclassification validation checklist

Flow diagram for major reclassificationReclassification applications

MHRA guidelineGuideline for the namingNaming of medicinalMedicinal productsProducts and Braille requirementsRequirements for nameName on labelLabel

MHRA reclassificationMHRA Reclassification fees

MHRA guidanceMHRA 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 TableApproved of approved reclassificationsReclassifications (MS Excel Spreadsheet, 39.4 KB) 1991 to 2024 contains the information on UK medicines reclassified from POMPrescription Only medicine (POM) to P,Pharmacy and P(P) Medicine, and P medicine to GSLGeneral medicineSales List (GSL) Medicine from 1991 to 2030 FebruarySeptember 2025.2024. The list will be updated every six months. From 1991 to– 2015 only the first reclassification of a substance is includedincluded, (furtherand further extensions such as wider indications, additional pack sizes or higher strengths arehave not included).been included. From 2016 all major and standard reclassifications are included. Reclassifications based on an analogous product (‘simple(known applications’)as 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.

Public Assessment Reports

We publish Public Assessment Reports (PARs) for reclassification applications within 60 days of grant of the application. This is based on the MHRA assessment report with any commercially or personally confidential information removed.  PARs for reclassifications can be found here.

Contact

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