The MHRA recently held a webinar on Reclassification of medicines within the UK as the process has been updated. To ensure we are constantly up to date and can give our clients the most efficient and correct advice, one of our Regulatory Executives attended the talk. 

The webinar consisted of: 

• An overview of reclassification and what the differences between the categories are 
• Information on the most recent updates to the classification process 
• An updated definition of an “analogous product” 
• What changes can and cannot be submitted within a reclassification application 
• Different reclassification application types 
• Navigating the reclassification validation checklist 

Keep reading for information on the areas mentioned above and how Callisto can aid and support you through the reclassification application and process. 

An Overview of Classifying and Reclassifying Medicines in the UK

The reclassification of medicines is essential to stay on top of as the MHRA uses a medicine’s legal classification to determine the level of control over its supply.  

There are three categories that a UK medicine can be classified within: 

• Prescription-Only Medicine (POM) – These medicines can only be prescribed by a doctor or other authorised healthcare professional and must be dispensed from a pharmacy or an equivalent licenced place.  
• Pharmacy (P) – Medicines of this classification can only be bought under a pharmacist’s supervision within a pharmacy. Most pharmacists will ask the buyer questions relating to their health and in some cases will advise the buyer to see a GP or healthcare professional before dispensing the medication to them. 
• General Sales List (GSL) – These are medicines which can be bought from retail stores, such as supermarkets, corner shops and newsagents. Although they are available to the general public some restrictions still apply such as smaller packaging sizes and limits on the numbers of packets a consumer can buy at a time. 

P and GSL medicines are collectively known as over-the-counter (OTC) medicines. 

All new medicines or new combination products are initially granted a POM licence. Overtime, once confidence starts to grow in the role of medicine and there is a wider understanding of its side effects, an application to reclassify it can be made. This is known as ‘reclassification’ or ‘switching’. 

Reclassification involves three types of switches: 

• Prescription-Only Medicines (POM) to Pharmacy (P) 
• Pharmacy (P) to General Sales List (GSL) 
• Prescription-Only Medicines (POM) to General Sales List (GSL) 

An applicant submitting a reclassification application must hold the relevant marketing authorisation (MA); alternatively, a new marketing authorisation application (MAA) could be submitted in combination with a reclassification application. 

What we at Callisto can do

Callisto’s Regulatory Affairs department has extensive expertise and experience in Market Authorisation, ensuring compliance and an efficient route to market. As MA’s and MAA’s are extremely valuable assets we can help you to obtain, protect and maintain them throughout the product lifecycle. 

We can also support with artwork changes or updates required and liaise with Regulatory Authorities, including attending Scientific Advise Meetings on your behalf.