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) - must be prescribed by a doctor or other authorised health professional and must be dispensed from a pharmacy or from another specifically licensed premises
- Pharmacy Medicine (P) - can be bought only from pharmacies and under a pharmacist’s supervision
- General Sales List Medicines (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 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 be exclusively obtained 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 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 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 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 2–3 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 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 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)
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 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” 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 status for a particular medicine. For example, a prescription-only medicine may additionally be classified into a pharmacy medicine category or a 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 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 list medicine 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 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.
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 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. This is called a major reclassification.
A company applying for a medicine to be classified either as a pharmacy medicine or a general sales 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 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 healthcare professionals and representatives of people affected by the classification change and run a public consultation.
The MHRA will tell the 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, 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 Sales List or Pharmacy to Prescription Only. In these cases, the 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.
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 and
- 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 six 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. Applicants are advised to contact the MHRA (variationqueries@mhra.gov.uk) to 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.
A simple reclassification should be made as a type IB or type II (analogous product) variation, and the timetable follows the normal timetable detailed in the link. The variation application should include details of the analogous product.
Major reclassifications
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. Major reclassifications must be referred 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 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.
For a full list of documents which must be submitted as part of a simple or major reclassification application please see the
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, a key 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 Prescription-Only Medicine to a Pharmacy Medicine or a Pharmacy Medicine to a General Sales List Medicine. These meetings are held in the early stages of processing a reclassification application and 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, and 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 held in the later stages of a reclassification assessment, after the application has been considered by the MHRA assessors and independent advice has been sought from the Commission on Human Medicines (CHM).
Additional information
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 Guidance on the application for exclusivity for change in legal status of a medicine
Legal status of substances
The table Approved Reclassifications 1991 to 2024 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 2024. 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 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.
Last updated 10 April 2024 + show all updates
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Updated Reclassification Guidance Document and Flowchart diagram for Reclassification Applications
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The following updates have been published: • An updated version of the reclassification guidance document. • A flow diagram outlining the timetable for national major or standard reclassification applications. • A reclassification validation checklist outlining documents required when submitting a reclassification application. Further information on the validity of an analogous product for simple reclassification applications has been included. Contact email updated.
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Major update to the guidance on reclassification
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The page has been updated to include info@mhra.gov.uk as the contact email address.
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Revised the date under sub-heading 'Legal status of substances' to 30 September (formerly 31 March).
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Added flow diagram for major or standard reclassification applications
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Approved Reclassifications updated.
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Uploaded PARs for Voltarol 140 mg Medicated Plaster, InVita D3 400IU soft capsules and InVita D3 800IU soft capsules
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The list of reclassified products has been updated.
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Added Public Assessment Report for the reclassification of Neutrogena T/Gel Therapeutic Shampoo
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Updated 'approved reclassifications' document.
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Added Public Assessment Report for the reclassification application to increase pack size of Nicorette QuickMist 1mg/spray mouthspray & Nicorette QuickMist smart track 1mg/spray mouthspray
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Added Public Assessment Report of the reclassification of Sudafed Plus Blocked Nose 1mg/50mg/ml Nasal Spray Solution
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Updated Approved reclassifications to 31 March 2022
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Addition of PAR for reclassification of Calci-D 1000mg/1000 IU chewable tablets from POM to P.
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Updated spreadsheet of approved reclassifications from prescription only medicine (POM) to pharmacy (P) medicine and P medicine to general sales list (GSL) medicine from 1991 to 30 September 2021.
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Added a link to the PAR for Nasacort Allergy Relief for Adults 55 micrograms/dose, nasal spray, suspension
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Updated the spreadsheet for approved reclassifications
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Added a link to the Public Assessment Report of the Reclassification of Almerg 180mg film-coated tablets
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Added a link to the Public Assessment Report for the reclassification of Almerg 180mg film-coated tablets
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This page has been updated to remove references to the EMA due to the end of the Brexit transition period.
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Added the Public Assessment Report of the Reclassification of Allevia 120mg Tablets
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Added link to Public Assessment Report of the Reclassification of Benacort Hayfever Relief for Adults 64 micrograms, nasal spray, in the section on Public Assessment Reports.
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Added new PAR on the reclassification of Benacort Hayfever Relief for Adults 64 micrograms, nasal spray from POM to GSL
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We have updated the attachment for the the approved reclassification. Now showing data from 1991 up to 30 September 2019.
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Added Sildenafil 50mg Film-coated Tablets PDF attachment under Public Assessment Reports
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Added the public assessment report for the reclassification of Omeprazole 20mg Gastro-Resistant Tablets PAR
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An updated table of approved reclassifications from 1991 to March 2019 has been added to the page under the 'Legal status of substances' page.
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Updated list of 'approved reclassifications' added to the page.
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New document - Pirinase Allergy 0.05% Nasal Spray PAR - has been uploaded.
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Added Voltarol PAR document
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Added Curanail 5% w/v Medicated Nail Lacquer PAR to list of Public Assessment Reports
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Updated list of Reclassified medicines.
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New PAR
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Added PAR for Ibuprofen Twelve Plus Pain Relief PAR
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Updated Ibuprofen attachment.
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Added "Public Assessment Reports" section
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Updated text.
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Updated the formatting of the page and clarified the guidance.
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First published.