Dave Rushton
Founder
of Paradigm Shift Consulting Limited.
Dave Rushton is Founder of Paradigm Shift Consulting Limited, a Good Distribution Practice Consultancy.
Blog
Take a look through our free blogs that cover a number of different areas of Good Distribution Practice (GDP). Each blog addresses primary topics including training, inspections and procedures. If you need any more information or any assistance/training don’t hesitate to contact us by email or phone.
GN14 Explained: What Pharma Wholesale Distributors Need To Know
Unlicensed Medicines: Key Guidance Note 14 (GN14) requirements for wholesale distributors When a pharmaceutical wholesaler becomes involved in the sale and supply of unlicensed medicines, often referred to as “Specials”, the scope of their Wholesale Distributors Authorisation (WDA) must include...
What Is A Medical Device?
What Are Medical Devices? Medical devices cover a broad and varied range of products that are intended for medical use in human beings. In the UK context (and derived from international definitions) a “medical device” means any instrument, apparatus, appliance, software, implant, reagent, material...
What is classed as a Medicine in the UK? (2025 Edition)
What is classed as a medicine in the United Kingdom: A Practical Regulatory Guide for Pharmaceutical Wholesalers & Distributors Understanding this is fundamental for any organisation involved in the wholesale distribution, storage, or supply of medicinal products. The UK maintains one of the...
Understanding Controlled Drugs Licensing 2026
What Wholesalers & Wholesaling Pharmacies of Controlled Drugs Must Know Holders of a Wholesale Distribution Authorisation (WDA) must abide by a range of complex regulatory landscape. If you supply medicines, in particular, controlled drugs in Schedules 2-5, there are dual obligations you must...
Do Pharmacies Need a WDA? (2026)
What Pharmacies Need to Know Now About WDA(H): A Full Guide for 2026 Supply chains in pharmacies have tightened significantly since the days of the “5% rule.” If you’re a pharmacy owner, superintendent pharmacist, or part of a hospital or community pharmacy, it’s essential to know whether your...
Applying for a WDA(V) (Veterinary Medicines Wholesale Distribution Authorisation) in 2026
What is a WDA(V)? A Wholesale Distribution Authorisation for veterinary medicines (WDA(V)) is the licence required to enable the procurement, sale, storage and distribution of medicines for veterinary purposes. In this blog we will explain who will require a WDA(V) and what the application process...
Application for a Wholesale Distribution Authorisation in 2026
The team at Paradigm Shift are often asked what the Wholesale Distribution Authorisation application process is. Whilst we have written about this subject in the past (Wholesale Dealers' Application and Wholesale Distribution Authorisation Explained), we thought it would be helpful to provide a...
Wholesale Distribution Authorisation (WDA) Explained for 2026
What is a Wholesale Distribution Authorisation (WDA)? Being in possession of a Wholesale Distribution Authorisation (WDA) – the terminology in the EU 2013/C 343/01 guideline - is a legal requirement for any company involved in the procurement, storage, or distribution of human or veterinary...
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. ...
Human Error is Not the Root Cause!
Strengthening Root Cause Analysis (RCA) in GDP At a time when the Medicines and Healthcare products Regulatory Agency (MHRA) continues to highlight deficiencies in deviation investigations, one thing is clear… effective root cause analysis is essential for compliance with Good Distribution...