How to Navigate Medicine Classifications (2026 edition)

Navigating Medicine Classifications, GDP Guidelines and WDA Scope.

For pharmaceutical distributors, the moment a product is determined to be a medicinal product, the regulatory landscape changes. Licence obligations, handling, supply chain and recipient eligibility are all affected. 

Pharmaceutical distributors must consider product classification as an integral part of their quality management system and as such, they must ensure their Wholesale Distribution Authorisation allows for the storage, handling and distribution of the medicinal products that they wish to supply to remain compliant with GDP guidelines and National law. 

MHRA Guidance: 

Guidance Note 8 (GN8) “A guide to what is a medicinal product”:

This is the primary reference for deciding whether a product is a medicine or non-medicine.  GN8 sets out the factors that the MHRA uses to determine the classification of the product.  Presentation, claims, composition mode of action are all considerations that impact the final decision as to whether or not a product is a medicine or a “borderline” product. 

Guidance Note 14 (GN14) “Guidance on the supply of unlicensed medicinal products (“Specials”):

This document explains the manufacture, importation, distribution and supply of unlicensed medicines, commonly referred to as “Specials”, including the responsibilities for suppliers and requirements for the supply of such products to prescribers and dispensers.  This guidance is essential when a product has no Market Authorisation (MA). 

It is worth noting that when a licensed medicinal product is prescribed for indications other than those documented on the product Summary of Product Characteristics (SmPC), this will then be considered an unlicensed medicine and GN14 requirements must be followed.  Similarly, should a vitamin, mineral or food supplement, that has not been granted an MA be prescribed, this would also be considered to be an unlicensed medicine and must be supplied with GN14 requirements adhered to. 

For more information relating to unlicensed medicines, visit our blog page and search “unlicensed medicines”. 

Clinical Trials / Investigational Medicinal Products (IMPs):

MHRA guidance on clinical trials authorisation, the manufacture and supply of IMPs documents the emphasis that clinical trials and IMPs have tighter documentation and traceability requirements than those needed by licensed medicines.  

Medical Device Guidance and Registration:

For borderline products and device only items, the MHRA have a host of documents and guidelines, including, Registration Requirements, UK MDR/ In Vitro Diagnostic Regulation (IVDR) context and the UK Responsible Person Role.  The MHRA clarifies how some products may be devices or medicines depending on the mode of action. 

Medicinal Product Classifications 

Medicinal product classification is the starting point of compliance in pharmaceutical wholesale distribution. Without knowing whether a product is a POM, P, GSL, unlicensed, an IMP, herbal or homeopathic, it is impossible to align the WDA scope, GDP procedures, and customer eligibility correctly. 

Here we provide a useful overview of the different medicinal products available in the UK: 

 Prescription Only Medicine (POM):

Medicines that can only be supplied against a valid prescription issued by an authorised prescriber, e.g. doctor, dentist, independent prescriber etc. 

Examples of POMs include: 

• Antibiotics 
• Strong painkillers 
• Injectable medicines 

Pharmacy Medicines (P): 

Medicines that can be sold or supplied only under the supervision of a pharmacist from a registered pharmacy. 
Examples of Ps include: 

• Stronger antihistamines 
• Antifungal creams 
• Low-strength painkillers in larger quantities 
• Emergency contraception  

General Sales List Products (GSL): 

Medicines deemed sufficiently safe for sale without the need for a prescription or pharmacist supervision. 
Examples of GSLs include: 

• Small packs of low-strength painkillers 
• Cough and cold remedies 
• Antacids 

Narcotic and Psychotropic/Controlled Drugs (CD):

Examples of CDs include: 

• Pam and Z drugs 
• Medical cannabis 
• Ketamine 
• Gabapentin 
• Morphine

Unlicensed Medicines (Specials):

Medicines prepared to meet the specific clinical need of an individual patient where no licensed medicinal product is available. Specials do not have a UK Marketing Authorisation.  Examples of Specials include: 

• Bespoke liquid formulations of a solid dose medicine 
• Imported medicines without a UK Marketing Authorisation 
• Bespoke topical formulations 
• Alternative strengths of capsules where a licenced alternative does not meet the patient needs 

Examples of products that commonly cause confusion 

The following categories frequently trigger borderline medicinal product decisions and should be treated as higher risk products from a classification and WDA perspective. 

• CBD/Cannabidiol preparations: Classification may shift between supplement, cosmetic or medicines depending on product claims and formulation. 

• Herbal and Traditional Remedies:
  Some qualify under the Traditional Herbal Registration (THR) scheme, others may be medicines requiring full authorisation, others may fall under GSL. 

• Topical Head-Lice Treatments and Parasitic Shampoos:
  Often classed as medicinal devices if mechanical in action, but medicines where the active ingredient is a pharmaceutical substance. 

• Cosmetics with Therapeutic Claims:
  Creams claiming to treat eczema may be reclassified as a medicinal product. 

• Food Supplements:
  Where a food supplement is prescribed to a patient, where a Marketing Authorisation is not in place, these products will become an unlicensed medicine and GN14 guidelines must be followed. 

Practical Implications for WDA holder 

Being in possession of a WDA does not give categorical permission to supply every type of medicinal product.  The WDA must clearly reflect the types of products handled, stored and distributed from the site. 

To ensure full compliance pharmaceutical wholesalers must: 

• Ensure all required classifications are listed on the company/site WDA 
• Confirm classification and legal basis for all products purchased, stored and distributed 
• Ensure a Home Office licence for controlled substances is in place for narcotic and psychotropic products 
• Ensure the pharmaceutical Quality Management System (PQMS) accurately covers the authorised product categories and activities 
• If supplying unlicensed medicines, ensure documented evidence-based records of the legal basis for supply as per GN14 requirements 
• Ensure suppliers of medicinal product hold the required licensed and ensure a Quality Technical Agreement (QTA) is in place 
• Ensure customer wishing to purchase medicinal products are legitimate and authorised to receive such products 

Conclusion 

When classification is uncertain, Responsible Persons must treat the product as high-risk and gather documentary evidence before any purchase/distribution activities occur.  GN8 remains the first port of call for borderline decisions.  GN14, clinical trial guidance and the MHRA medical device pages are the next steps depending on the product type.   

Documented decisions, explicit WDA checks and confirmation of authorised activities and strong operational checks are how pharmaceutical wholesale distributors keep medicinal product supply chains open and compliant. 

Help and Support 

Could you benefit from some help and support ensuring that your products and activities are aligned with your WDA?  Do your SOPs require a review to ensure they are compliant with your WDA and business activities? 

Paradigm Shift consultants are here to help.  Contact us today for a free 5-minute consultation.