Guidance

Medicines: reclassify your product

Pharmacy, prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.

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) - has to be prescribed by a doctor or other authorised health professional and it has to be dispensed from a pharmacy or from another specifically licensed place;
  • Pharmacy (P) - an intermediate level of control, can be bought only from pharmacies and under a pharmacist’s supervision;
  • General Sales List (GSL) - may be bought from retail stores, such as a newsagent, a supermarket or a vending machine in a shop.

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

Benefits Barriers
Quick relief of the disorder Potentially troublesome or serious side effects
Individual can exercise more 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, at MHRA’s London offices, 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. 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. We also explain how the categories relate to the term over-the-counter (OTC) medicines.

Prescription-only medicines

Medicine 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 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 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 medicines

People 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.

The 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) medicine

A medicine will be non-prescription unless it fulfills 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 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:

  • introduction of one or more additional legal classes. For example, a prescription-only medicine may additionally be classified into a pharmacy medicine category or a general sale medicine category. In such a case, the quantity, dose and the conditions for which the medicine is used may be restricted when it is supplied within the new categories compared to the original prescription-only 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
  • 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 MHRA, we have set out a procedure for requesting a classification change. 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 MHRA on how to apply for a classification change and what evidence needs to be submitted. MHRA assesses the application once it has been submitted formally. Depending on the nature of the proposed classification, 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.

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, MHRA (or the European Medicines Agency) 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 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.

Major and standard reclassifications

A 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:

  • product information - summary of product characteristics (SPC), 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

This flow diagram and timetable (PDF, 65.5KB, 6 pages) 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 reclassification@mhra.gov.uk 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 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:

  • has the same active ingredient, route of administration and use
  • has the same strength or a higher strength
  • has the same dosage or daily dosage, or a higher dosage or daily dosage
  • 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

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.

Additional information

More detailed information on the POM to P or P to GSL reclassification process can be found in our guidance on how to change the legal classification of a medicine in the UK (PDF, 335KB, 33 pages) .

MHRA guidance on naming medicines (PDF, 235KB, 20 pages)

MHRA reclassification fees

You can find more information in the CMDh best practice guide for authorisation of non-prescription medicines in the decentralised and mutual recognition procedures. If your product is a centrally authorised product you should submit your reclassification application directly to the European Medicines Agency (EMA).

The table Approved Reclassifications (MS Excel Spreadsheet, 25.5KB) 1991 - 2018 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 March 2018. 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 info@mhra.gov.uk.

Public Assessment Reports

Listed 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.

Deep Relief Anti-Inflammatory Gel PAR (PDF, 127KB, 6 pages)

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

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

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

Contact

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

Published 18 December 2014
Last updated 8 May 2018 + show all updates
  1. Updated list of Reclassified medicines.
  2. New PAR
  3. Added PAR for Ibuprofen Twelve Plus Pain Relief PAR
  4. Updated Ibuprofen attachment.
  5. Added "Public Assessment Reports" section
  6. Updated text.
  7. Updated the formatting of the page and clarified the guidance.
  8. First published.