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

There are 3 ways that medicines can be sold and supplied in the UK:

  • on a prescription (referred to as prescription-only medicines (POMs))
  • in a pharmacy without prescription, under the supervision of a pharmacist (P)
  • as a general sale list (GSL) medicine and sold in general retail outlets without the supervision of a pharmacist

New medicines are usually authorised for use as POMs. After some years’ use, if there is enough evidence to support the safe use of the product without a doctor’s supervision a medicine may be reclassified to P.

Pharmacy medicines which have been safely used for several years may be reclassified as GSL.

Reclassification of a product normally follows a request from the company which holds a marketing authorisation (MA) (product licence) for it. However, requests can be made by any interested party, such as a professional body, or be initiated by the Medicines and Healthcare products Regulatory Agency (MHRA).

Rarely, medicines which were previously classified as P are made POM if new risks are identified which need a doctor to ensure safe use of the medicine.

A GSL medicine may be reclassified as P if new information shows that it is no longer safe to supply it without a pharmacist checking that it is suitable for the patient.

Prescription-only medicine (POM) to pharmacy (P) medicine

To be reclassified from POM to P, a medicine must:

  • be unlikely to be a direct or indirect danger to human health when used without the supervision of a doctor, even if used correctly
  • be generally used correctly (ie not frequently or to a wide extent used correctly)
  • not contain substances or preparations of substances where the activity of the product or its side effects require further investigation
  • not normally be prescribed by a doctor for injection (parenteral administration)

Pharmacy medicine to the general sale list (GSL)

To be reclassified from P to GSL, a medicine must be safe to be used without the supervision of a pharmacist.

The reclassification process

A reclassification only applies to the product covered by that MA. You’ll need to make a separate application to reclassify products with a different MA.

We recommend that you have a scientific advice meeting with us before you make your reclassification application.

See our guidance on how to change the legal classification of a medicine in the UK (PDF, 335KB, 33 pages) for more detailed information, including:

  • how to prepare the application to reclassify your medicine
  • procedures
  • criteria for classification
  • data requirements for reclassification applications

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 (eg if it’s a larger pack size).

The reclassification application should include:

  • product information (summary of product characteristics (SPC), labelling and patient information leaflet (PIL))
  • (for POM to P reclassifications) 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

‘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. The variation application should include details of the analogous product.

Application routes

For products with a national, mutual recognition or decentralised licence you can apply for a variation to your marketing authorisation.

If you want to keep a POM version of the product you should apply for a duplicate marketing authorisation which can then be reclassified through one of the reclassification processes outlined above.

In most cases it is possible to combine the applications to duplicate and reclassify a product. However if you intend to apply for a simple reclassification as a type 1B variation, the duplicate and reclassification applications have to be done separately.

In this case, when you submit your application to duplicate the marketing authorisation you should explain in your covering letter that you are applying for a duplicate for reclassification purposes.

If the reclassified version of the product has different indications, contraindications and/or warnings from the POM version the 2 products (marketing authorisations) must have different invented names.

If the only difference between the POM and P or GSL product is the pack size the 2 products can have the same name.

Further information is available in the MHRA guidance on naming medicines.

Marketing authorisations determined by mutual recognition or decentralised procedures may require special consideration. We advise you seek a scientific advice meeting with us at an early stage.

You can find more information in the best practice guide for authorisation of non-prescription medicines in the decentralised and mutual recognition procedures.

The timetable for the Decentralised Procedure is also useful.

If your product is a centrally authorised product you should submit your reclassification application directly to the European Medicines Agency (EMA).

If you are considering reclassifying a product you can get details of specific products from info@mhra.gsi.gov.uk.

Fees

Fees for reclassifying your medicine

Make a payment to MHRA

Timetable

We base the timetable on the published timelines for the type of application submitted, with time to allow for a stakeholder group meeting. For analogous product variations the usual variations timelines will apply, depending upon the route used to submit the variation.

Data exclusivity

Once your product has been reclassified you could have one year of data protection during which MHRA cannot refer to your data when looking at an application by another applicant for the same substance.

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

Contact

Email: reclassification@mhra.gsi.gov.uk

Reclassification unit
3M
151 Buckingham Palace Road
London
SW1W 9SZ