UK Good Distribution Practice (Rules & Guidance for Distributors)
The UK good distribution practice requirements administered by the MHRA (consolidated in the "Green Guide", Rules and Guidance for Pharmaceutical Manufacturers and Distributors). Post-Brexit UK GDP mirrors the EU 2013/C 343/01 guidelines, with a Wholesale Dealer's Licence and a named Responsible Person.
Holders of a UK Wholesale Dealer's Licence (WDA(H)) and the UK medicinal-product supply chain. Distinct licensing but technically aligned with EU GDP.
- 01Hold a Wholesale Dealer's Licence with a named Responsible Person
- 02Apply GDP controls equivalent to EU 2013/C 343/01
- 03Perform bona-fide and qualification checks across the supply chain
UK GDP remains aligned with EU GDP post-Brexit; monitor MHRA guidance for any future divergence.
MHRA GDP: frequently asked questions
Quick answers to common questions about MHRA GDP.
What is MHRA GDP?
MHRA GDP — UK Good Distribution Practice (Rules & Guidance for Distributors) — is a guidance issued by the Medicines and Healthcare products Regulatory Agency (United Kingdom). The UK good distribution practice requirements administered by the MHRA (consolidated in the "Green Guide", Rules and Guidance for Pharmaceutical Manufacturers and Distributors). Post-Brexit UK GDP mirrors the EU 2013/C 343/01 guidelines, with a Wholesale Dealer's Licence and a named Responsible Person.
Who does MHRA GDP apply to?
Holders of a UK Wholesale Dealer's Licence (WDA(H)) and the UK medicinal-product supply chain. Distinct licensing but technically aligned with EU GDP.
What are the key requirements of MHRA GDP?
MHRA GDP requires, among other things: Hold a Wholesale Dealer's Licence with a named Responsible Person; Apply GDP controls equivalent to EU 2013/C 343/01; Perform bona-fide and qualification checks across the supply chain.
When was MHRA GDP last updated?
The current version of MHRA GDP dates from January 2024. UK GDP remains aligned with EU GDP post-Brexit; monitor MHRA guidance for any future divergence.
Track the standards that move
When MHRA GDP — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.