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UK MHRA Guidance: Medicines: How to Reclassify your Product

Today (August 4, 2022) UK Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance for the industry, “Guidance: Medicines: reclassify your product.


Legal classification determines the level of control over a medicine's supply and is based on how much professional input is needed to diagnose and treat the conditions it may be used for.

Currently, there are three categories that medicine can be classified:

  • 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.

This guidance details about 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 of the medicine’s role and improved understanding of its side effects can lead to a change in classification.


Types of reclassification procedure

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.


Simple reclassification

A ‘simple’ application is based on an analogous product which has already been reclassified.


CLICK this LINK to know more about Procedure for requesting a classification change and also CLICK on this LINK for guidance on Medicines that you cannot export from the UK or hoard.


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