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 three categories that a medicine can be classified within:

• Prescription-Only Medicine (POM)(POM) - musthas to be prescribed by a doctor or other authorised health professional and mustit has to be dispensed from a pharmacy or from another specifically licensed premises;place;
• Pharmacy Medicines(P) (P) - an intermediate level of control, can be bought only from pharmacies and under a pharmacist’s supervision;
• General Sales List Medicines(GSL) (GSL) - may be purchasedbought withoutfrom the supervision of a pharmacist and are available in retail outlets,stores, such as a newsagent, a supermarket,supermarket or a vending machine in a shop.

The fundamentalunderlying principle guidingfor theclassifying classification of medicines is to optimisemaximise timely access to effective treatmentsmedicines while reducingminimising the risk of harm from improperinappropriate 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 greatermore autonomy and choice	Possibility of misdiagnosis and delay in correct treatment
Rapid and convenient access to medicines	Potential for harm from incorrect use

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, and we are seeking input from patients and health professionals into the reclassification process. In addition to safety considerations, a key factor in the reclassification process is focusing on issues that matter to patients and health professionals. In order to understand those issues we run stakeholder groups and public consultations.

Stakeholder groups

Stakeholder groups are composed of representatives from the public and health professionals. Their input takes the form of a half-day meeting on an ad hoc basis when we have an application for a specific medicine. Each meeting will discuss the possible reclassification of a specific prescription-only medicine to a pharmacy medicine or a pharmacy medicine to a general sales medicine. Stakeholder Groups consider a proposed reclassification in the early stages of processing a reclassification application.

Get involved!

We would like to hear from patients with an interest in medicines and self-care, and community pharmacists, GPs, nurses and healthcare professionals who are currently working in a patient-facing role and who are willing to reflect on professional issues and attend a short meeting if required. If you are interested in taking part, please email engagement@mhra.gov.uk. We will keep your details and contact you when a specific product is under discussion.

This work is supported by the UK Medicines Reclassification Platform.

Public consultations

We also run 21 day public consultations for some medicines that are being reclassified, and these are published on the consultations page when available. These consultations seek your views on the reclassification of a specific medicine. Public consultations are run later in the processing of a reclassification application, after the application has been considered by the MHRA Assessors and after independent advice has been sought from the Commission on Human Medicines.

Classifications of medicines

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

Prescription-only medicines

MedicinesMedicine packs classified as ‘prescription only’ can be exclusively obtained only against 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, prescription-only medicines are used for conditions that are best diagnosed and managed by health professionals. Examples of prescription-only medicines include virtually all antibiotics and medicines for treating epilepsy.high blood pressure.

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 term treatment of medical conditions that can be readily identified readily and are not likely to persist, although they may sometimes be available for the management of long-termlong 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 the medicine is 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-termlong 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 containing codeine for erectiletreating dysfunction.pain that is not relieved by aspirin, ibuprofen or paracetamol alone.

General Salessale List Medicinesmedicines

People can buy general salessale listmedicine medicinespacks from retail outlets such as corner shops and supermarkets. The medicinesmedicines—also arecalled ‘general sales list (GSL) medicines’—are also available for self-selection in pharmacies. General salessale list medicines are taken for common, easily recognised ailments which usually last around 2–3 days. These medicines cause few troublesome side effects in normal use.

To reduce the chances of harm from inappropriate use, many general salessale list medicines packs contain only a few doses,doses and they often carry advice to get help from a health professional if the ailment does not improve or gets worse. A general salessale list medicine may be recommendedadvised for treating a limited range of conditions whereas 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 salessale list medicines. Also, generalmedicines salesin listgeneral medicinessale packs may be used for only certain groups of people; for example, they may not be recommendedadvised for use by children or during pregnancy.

Examples of general salessale list medicines include small packs of painkillers,painkillers and of antihistamines for hayfever and other allergies.

Over-the-counter medicines

‘Over-the-counter (OTC)(OTC) medicines’ covers all general salessale 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,change—we we call this reclassification. It is also sometimes called ‘switching’. Growing confidence inof the medicine’s actionrole and improved understanding of its side effects can lead to a change in classification.

Prescription-OnlyPrescription-only Medicinemedicine (POM)(POM) to Pharmacypharmacy Medicine(P) (P)medicine

A medicine will be non-prescription unless it fulfils the criteria for prescription control as set out below.

Prescription only status will 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 Generalthe Salesgeneral Listsale Medicinelist (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” has 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 statusclasses. for a particular medicine. For example, a prescription-only medicine may additionally be classified into a pharmacy medicine category or a general salessale 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 within the new categories compared to the original prescription-only category.category
• switching over entirely from one classification to another. For instance, all packs of a pharmacy medicine category could be changed to the general sale medicine category. In this case, the previous pharmacy medicine category would no longer apply to that medicine.medicine
• occasionally, removal of a general sale medicine category or a pharmacy medicine category, leaving the medicine classified into fewer categories

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 comprise clinical studies, extensive clinical use indicating acceptable level of side effects, advice of experts, views of relevant health professionals and their professional bodies, as well as the 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. This may involve tying the proposed classification change to measures that include:

varying or restricting	introducing
the dosage	new medicine-related training and information for health professionals
duration of use	clear guidance to the public on labels and leaflets on when and how to use the medicine
pack size	means to collect evidence on the effectiveness and safety of new classification
allowable uses of the medicine
categories of individuals who can use the medicine

Procedure for requesting a classification change

At the MHRA,the MHRA, we have set out a procedure for requesting a classification change. The MHRA procedureThe 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. ThisThese isare called a simple reclassification.or ‘me-too’ reclassifications. However, a more detailed stepwisestep-wise procedure applies if the classification request breaks new grounds, for example if it is for a type of medicine that has never undergone a classification change or if it is for a condition that was not previously considered during a classification change. ThisThese isare called aeither major reclassification.or standard reclassifications.

A company applying for a medicine to be classified either as a pharmacy medicine or a general salessale list medicine, needs to first collect the evidence that it is likely to be used appropriately and with relatively little danger to the public.

Companies are encouraged to ask for scientific advice from the MHRA onthe MHRA on how to apply for a classification change and what evidence needs to be submitted. The MHRA assessesThe MHRA assesses the application once it has been submitted formally. Depending on the nature of the proposed classification, the MHRA mightthe MHRA might also take advice from its committees of external experts, consult a group, (‘stakeholder group’), comprising healthcarehealth professionals and representatives of people affected by the classification change and run a public consultation.

The MHRA willThe MHRA will tell the requesting organisation of the outcome of the reclassificationclassification application and it will give reasons for the decision.

On rare occasions, after thorough consideration by expert committees, the MHRA 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 General SalesSale List or Pharmacy to Prescription Only. In these cases,cases the MHRA 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 the company’s reclassification proposal.

SimpleMajor reclassificationand standard reclassifications

A ‘simple’reclassification application is basedmajor onif, anfor analogousexample, productit’s whichthe hasfirst alreadyin beena reclassified.new Antherapeutic analogouscategory productor is a medicinalnew producttarget whichpopulation hasfor aan marketingexisting authorisation,product. canMajor bereclassifications marketedmust inbe thereferred UKto andan meetsexpert the following criteria:committee.

• has

  A thereclassification sameis active‘standard’ ingredient,if routeit ofdoesn’t administrationneed andto use

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• has(This theis sameusually dosagethe orcase, dailyfor dosage,example, orif athe higherreclassification dosage or daily dosage and
• is forin salerelation orto supplya atlarger thepack samesize quantityof or a greater quantity as the medicinal product inalready relationclassified toas whichP theor application is made

GSL).

The analogousreclassification productapplication should haveinclude:

• product beeninformation on- thesummary marketof duringproduct thecharacteristics previous(SPC), sixlabelling months and mustpatient notinformation haveleaflet been(PIL)
• a removedclinical foroverview reasonsdemonstrating ofthat safety,the quality,criteria orare efficacy.met Exceptionally,for itreclassification.
• a mayrisk bemanagement possibleplan to(RMP) acceptoutlining certainthe productsimportant whichrisks haveassociated notwith been on the UKreclassification marketof forthe overproduct 6and months as analogous products. Applicants are advised to contact the MHRAplans (variationqueries@mhra.gov.uk) to seekmanage guidance on the eligibility of these products.risks

All Inapplications thesewhich circumstances,are acceptancenot offor thean proposed analogous product will be determined on a case-by-case basis.

A simple reclassification should be madesubmitted as amajor, type IB or type II (analogous product) variation, and thethese timetablewill followsbe thedowngraded normalto timetablestandard, detailedif inrequired theduring link. The variation application should include details of the analogousassessment product.process.

MajorSimple and standard reclassificationsreclassification

A reclassification‘simple’ application is majorbased if,on foran example,analogous itproduct iswhich thehas firstalready inbeen areclassified. newAn therapeuticanalogous categoryproduct oris a newmedicinal targetproduct populationwhich forhas ana existingmarketing product.authorisation, Majorcan reclassifications must be referredmarketed toin anthe expertUK committee.

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• has itthe willsame bestrength downgradedor to a ‘standard’higher application.

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• has reclassificationthe applicationsame shoulddosage include: *or productdaily informationdosage, -or summarya ofhigher productdosage characteristicsor (SmPC),daily labellingdosage
• is andfor patientsale informationor leafletsupply (PIL) *at a clinical overview demonstrating that the criteriasame arequantity metor for reclassification * a riskgreater managementquantity planas (RMP) outlining the importantmedicinal risksproduct associatedin withrelation theto reclassificationwhich of the productapplication andis the plans to manage these risks
  made

AllA applicationssimple whichreclassification are not for an analogous product should be submittedmade as major,a andtype theseIB willor betype downgradedII tovariation, standard,and ifthe requiredtimetable duringfollows the assessmentnormal process.

Fortimetable adetailed fullin listthe oflink. documentsThe whichvariation mustapplication beshould submittedinclude asdetails part of a simple or major reclassification application please see the validationanalogous checklist.product.

PublicAdditional consultationsinformation

PublicMore consultationsdetailed areinformation conducted on athe case-by-casePOM basis.to PublicP consultationsor forP reclassificationto applicationsGSL usuallyreclassification runprocess forcan 21be days,found andin theseour areGuidance published on the consultationshow page whento available.

Additionalchange information

Reclassificationthe guidance

Reclassificationlegal validationclassification checklist

Flowof diagrama formedicine majorin orthe standard reclassification applicationsUK.

MHRA Guidelineguidance for the Naming of Medicinal Products and Braille Requirements for Name on Labelnaming medicines

MHRA reclassificationMHRA reclassification fees

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

Legal status of substances

The table Approved Reclassifications 1991 - 2022 contains the information on UK medicines reclassified from Prescriptionprescription Onlyonly medicine (POM)(POM) to Pharmacy (P)(P) Medicine,medicine and P medicineand P medicine to Generalgeneral Salessales Listlist (GSL)(GSL) Medicine from 1991 to 30 September 2022.2023. The list will be updated every six months. From 1991 – 2015 only the first reclassification of a substance is included, and further extensions such as wider indications, additional pack sizes or higher strengths have not been included. From 2016 all major and standard reclassifications are included. Reclassifications based on an analogous product (known as simple‘me-too’) 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 from info@mhra.gov.uk.

Public Assessment Reports

WeListed publishbelow are the Public Assessment Reports (PARs) for reclassification applications withinthat 60have daysnot ofbeen grantsubject ofto thean application.ARM Thispublic isconsultation. basedThese reports are published on the MHRAday assessmentan reportapplication is granted.

The reports appear in chronological order, with anythe commerciallymost orrecently personallypublished confidentialreport informationat removed. the beginning.

The PARs for major reclassification applications and standard reclassifications canthat behave foundbeen heresubject to an ARM public consultation are published on the consultations page. with the details and results of the ARM consultation.

InVita D3 800IU soft capsules PAR (PDF, 118 KB, 5 pages)

InVita D3 400IU soft capsules PAR (PDF, 118 KB, 5 pages)

Public Assessment Report for the reclassification of Neutrogena T/Gel Therapeutic Shampoo

Public Assessment Report for the reclassification application to increase pack size of Nicorette QuickMist 1mg/spray mouthspray & Nicorette QuickMist smart track 1mg/spray mouthspray

Public Assessment Report of the reclassification of Sudafed Plus Blocked Nose 1mg/50mg/ml Nasal Spray Solution

Buscopan IBS Relief, Hyoscine Butylbromide 10mg tablets

Calci-D 1000mg/1000 IU chewable tablets PAR

Nasacort Allergy Relief for Adults 55 micrograms/dose, nasal spray, suspension PAR

Almerg 180mg film-coated tablets PAR

Allevia 120mg tablets PAR

Benacort Hayfever Relief for Adults nasal spray PAR

Sildenafil 50mg Film-Coated Tablets PAR (PDF, 175 KB, 5 pages)

Omeprazole 20mg Gastro-Resistant Tablets PAR (PDF, 175 KB, 7 pages)

Pirinase Allergy 0.05% Nasal Spray PAR (PDF, 110 KB, 6 pages)

Voltarol Gel Public Assessment Report (PDF, 94.6 KB, 6 pages)

Ibuprofen Twelve Plus Pain Relief PAR (PDF, 53.8 KB, 6 pages)

Piroxicam 0.5%w/w Gel PAR (PDF, 55.8 KB, 5 pages)

Regaine for Women 5% Foam (PDF, 63.6 KB, 7 pages)

Contact

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