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: Show
The underlying principle for classifying medicines is to maximise timely access to effective medicines while minimising the risk of harm from inappropriate use. Making medicines available over-the-counter: the trade-offs
Public and professional inputWe 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 groupsStakeholder 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 . 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 consultationsWe 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 medicinesThe three legal categories are explained here, with examples of medicines in each of the categories. We also explain how the categories relate to the term over-the-counter (OTC) medicines. Prescription-only medicinesMedicine packs classified ‘prescription only’ can be 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). A rectangular box enclosing the letters 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 high blood pressure. Pharmacy medicinesPeople 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 identified readily 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 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 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 treating pain that is not relieved by aspirin, ibuprofen or paracetamol alone. General sale medicinesPeople can buy general sale medicine packs from retail outlets such as corner shops and supermarkets. The medicines—also called ‘general sales list (GSL) medicines’—are also available for self-selection in pharmacies. General sale 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 sale medicines packs 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 sale medicine may be advised 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 sale medicines. Also, medicines in general sale packs may be used for only certain groups of people; for example, they may not be advised for use by children or during pregnancy. Examples of general sale medicines include small packs of painkillers and of antihistamines for hayfever and other allergies. Over-the-counter medicines‘Over-the-counter (OTC) medicines’ covers all general sale 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 medicineThe legal classification of a medicine may sometimes change—we call this reclassification. It is also sometimes called ‘switching’. Growing confidence of the medicine’s role and improved understanding of its side effects can lead to a change in classification. Prescription-only medicine (POM) to pharmacy (P) medicineA medicine will be non-prescription unless it fulfils the criteria for prescription control as set out below. Prescription only status will apply where:
In the UK these criteria are laid down in the Human Medicines Regulations 2012, regulation 62(3). Pharmacy medicine (P) to the general sale list (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” 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:
Evidence to support the classification changeA 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:
Procedure for requesting a classification changeAt 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. These are called simple or ‘me-too’ reclassifications. However, a more detailed step-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. These are called either major or standard reclassifications. A company applying for a medicine to be classified either as a pharmacy medicine or a general sale 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 on how to apply for a classification change and what evidence needs to be submitted. The MHRA assesses the application once it has been submitted formally. Depending on the nature of the proposed classification, the MHRA might also take advice from its committees of external experts, consult a group, (‘stakeholder group’), comprising health professionals and representatives of people affected by the classification change and run a public consultation. The MHRA will tell the requesting organisation of the outcome of the classification application and it will give reasons for the decision. On rare occasions, after thorough consideration by expert committees, the 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 Sale or Pharmacy to Prescription Only. In these cases the MHRA will work closely with affected companies to make the necessary changes. Types of reclassification procedureThere are different types of reclassification procedure depending on the company’s reclassification proposal. Major and standard reclassificationsA reclassification is major if, for example, it’s the first in a new therapeutic category or a new target population for an existing product. Major reclassifications must be referred to an expert committee. A reclassification is ‘standard’ if it doesn’t need to be referred to an expert advisory committee (This is usually the case, for example, if the reclassification is in relation to a larger pack size of a product already classified as P or GSL). The reclassification application should include:
This outlines the process followed for major and simple reclassifications. All applications which are not for an analogous product should be submitted as major, and these will be downgraded to standard, if required during the assessment process. There is a slot booking system for receiving and assessing major reclassification applications. Applicants should apply for a slot by emailing as soon as they can confirm that their application will be ready for submission. Once a slot is booked the application must be submitted on the agreed date; otherwise the slot may be lost and the applicant will need to apply for another one. Simple reclassificationA ‘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:
A simple reclassification should be made as a type IB or type II variation, and the timetable follows the normal timetable detailed in the link. The variation application should include details of the analogous product. More detailed information on the POM to P or P to GSL reclassification process can be found in our .
MHRA reclassification fees
The table 1991 - 2021 contains the information on UK medicines reclassified from prescription only medicine (POM) to Pharmacy (P) medicine and P medicine to general sales list (GSL) Medicine from 1991 to 31 March 2022. 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 ‘me-too’) 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 . Public Assessment ReportsListed below are the Public Assessment Reports (PARs) for reclassification applications that have not been subject to an ARM public consultation. These reports are published on the day an application is granted. The reports appear in chronological order, with the most recently published report at the beginning. The PARs for major reclassification applications and standard reclassifications that have been subject to an ARM public consultation are published on the consultations page with the details and results of the ARM consultation. 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
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