Under the Presentational Limb, the Medicines and Healthcare products Regulatory Agency (MHRA) will consider the validity of assertions, characteristics and claims being made for it as a whole, and whether it is being presented as a medicinal product.

Under the Functional Limb, the MHRA will consider its actual function and its intended use, and whether it is to be administered with a view to achieving a medical purpose.

The Licensing of a Medicinal Product

Marketing authorisation is required in order to sell or supply medicinal products* (*as defined in the Human Medicines Regulations 2012 (HMR), which is issued by the MHRA. Once granted, the medicinal product can be sold or supplied in the UK under the terms of that licence. 

Classification of Medicinal Products

The parameters of the marketing authorisation will include details as to the indication for which it

can be used, along with its conditions of sale (e.g whether the product is ‘POM’ (prescription only), ‘P-Meds’ (pharmacy only) or ‘general sale’ (over the counter).  For the UK, the criteria to establish the classification of a medicinal product is laid out in the HMR.  

When is a Medicine Given POM Status?

Prescription Only (POMs) – medicines restricted for use under medical supervision and available only on prescription from an authorised medical practitioner.

The MHRA Guidance https://www.gov.uk/government/collections/how-to-reclassify-your-medicine provides that a medicine will be classed as a POM  where it can be said that “a  direct or indirect danger exists to human health, even when used correctly if used without medical supervision; or there is frequently incorrect use which could lead to direct or indirect danger to human health, or further investigation of activity and/or side-effects is required, or the product is normally prescribed for parenteral administration”.

When is a Medicine Given P-Meds Status?

Pharmacy Medicines (P-Meds) – Can be obtained at a pharmacy without a prescription but under the supervision of a pharmacist. 

On first application for a license for a medicine, if it is determined that the medicine will not have an over the counter status, it will be categorised as a POM. On further application, and subject to eligibility, a POM may be re-classified as a P-Meds. 

When is a Medicine Given General Sales List Status

General Sales List (GSL) (OTC) – Available through general retail outlets without a pharmacist’s supervision.

As per MHRA Guidance, It is appropriate for a medicine to be given GSL status where it can be said to be sold or supplied without the supervision of a pharmacist with “reasonable safety”. “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” 

GSL medicines can be sold from a range of general sales premises, such as supermarkets, they can be closed to exclude the public (e.g. the premises is lockable,) and they are pre-packed in their original containers.

Re-Classification Considerations

There are various re-classification considerations such as an indication for which the re-classified product will be used, the dosage, target population, pack size, name, proposed controls for POM, P-Med or GSL, changes to patient information, pharmacy training and educational materials and real-world data collection, and updates.

The Re-Classification Process

There are different types of applications:

  • Major – expert advisory committee input required (e.g., the first in a new therapeutic category, or a new target population for an existing product).
  • Standard – a Major application has already been submitted, MHRA determines expert advisory committee input is not needed (e.g., it’s a second product within a therapeutic category, no significant differences in the safety profile).
  • Simple – “me-too” application, based on an analogous product that has already completed the reclassification procedure.

As part of the Reclassification Process, prior to the submission of the application, a Scientific Advisory Meetings (SAM) may be required where the following is assessed:  

  • the data which will need to be submitted
  • Input from stakeholders? (KOLs, Pharmacists, Practising HCP opinions, patient organisations)?.
  • Status of the medicine in other Countries
  • Will the Commission on Human Medicines (CHM) Advice be required (Major applications)
  • Publication on MHRA website for comment, input from stakeholders, advisory committee
  • Adverse Events, Safety
  • Proposed changes to dosing, indications etc……
  • Safety Profile

The SAM evaluation will inform the Summary of Product Characteristics “SPC”, labelling, identification of potential gaps, further data generation, provisional agreement of the type of application and a timetable.

Reclassification Application

The Reclassification Application will consist of the following elements:

  • Product/Patient Information (SPC, labelling and patient information leaflet)
  • Reclassification Clinical Overview – a critical evaluation of the proposed non-prescription product demonstrating that none of the prescription criteria apply or in the case of an application for GSL supply that the product can be sold or supplied with reasonable safety without pharmacist supervision.
  • Risk Management Plan (RMP) – outlining the important risks associated with the reclassification of the product and the proposals to manage these risks such as clear product information and in some cases other measures including any provisions for appropriate education and training for pharmacists and pharmacy staff.

Changes to the Marketing Authorisation & Brand Name

New Indication

If the re-classification is required for a new indication which is to be added to the medicine, so that the medicine has a POM status for at least 1 of the indications, then a new separate marketing authorisation will be required for each status (e.g. POM & P-Meds), along with a different name for each classification.

Re-Classification Only

Separate MA and same Brand Name Only where: a change in legal classification is due only to a difference in its status, pack size, all other aspects of the marketing authorisation is the same; the same brand name can be used; provided that the MAs are maintained such that no divergence between the authorisations will take place. If divergence takes place at a later date, a new brand name will need to be used for the divergent authorisation.

Data Exclusivity

The Human Medicines Regulations, regulation 64A allows for one year’s data exclusivity following the change of classification of a medicinal product where the results of pre-clinical tests or clinical trials are submitted with the application and those data are the basis for the change in legal classification. This data cannot then be used where the MHRA then examines another application by a different applicant for the same substance for one year after the initial change. The Data must be pertinent, specific and integral to the argument for a successful switch; and fundamental to the assessment of the switch application. 

MHRA Guidance

 For further information on the reclassifying of prescription-only medicines to pharmacy-only & over the counter medicines, or support with this area, please contact wendylg@lslaw.co.uk or take a look at LS Law other services here.

References for reclassifying prescription only medicines: 

  • MHRA Guidance: https://www.gov.uk/guidance/medicines-reclassify-your-product
  • The legislation and guidance which supports MHRA Guidance can be found here:
    • The Human Medicines Regulations 2012 as amended
    • The Prescription Only Medicines (Human Use) Order 1997 (The POM Order)
    • Medicines (Products for Human Use) (Fees) Regulations 2016 as amended
    • Risk Management Plans: Good pharmacovigilance practices: Module V Risk management systems provide information on content and structure


*PIPA  – Pharmaceutical Information and Pharmacovigilance Association is a membership association for professionals working within the fields of medical information, pharmacovigilance and related functions in the pharmaceutical industry, and they provide training, events, guidance, resources and networking opportunities. 

© Life Science Law 28th October 2021. ‘Reclassifying prescription-only medicines’ Presentation.