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What Are the Main Elements of GDP Guidelines in 2026?

What Are the Main Elements of GDP Guidelines in 2026?

GDP Guidelines: The Main Elements The GDP guidelines (Good Distribution Practice) for medicinal products consist of ten working chapters and two annexes, which cover the following topics: Chapter 1 – Quality Management We start the GDP guidelines with describing...
GN14 Explained: What Pharma Wholesale Distributors Need To Know

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...
Understanding Controlled Drugs Licensing 2026

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...
Application for a Wholesale Distribution Authorisation in 2026

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...
Wholesale Distribution Authorisation (WDA) Explained for 2026

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...
How to Navigate Medicine Classifications (2026 edition)

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...