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.
What this does not cover
stated in the document's own scope- Covers the wholesale distribution of medicines, not their manufacture, which is governed by GMP and a Manufacturer’s Licence.
- Addresses distribution of finished medicines, not active substances, whose importation and distribution follow separate GDP-for-active-substances provisions.
- Is the distribution standard, not the product marketing authorisation, which is a distinct regulatory decision.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
MHRA Good Distribution Practice is the set of requirements governing the wholesale distribution of medicines in the UK, consolidated for practitioners in the MHRA’s “Green Guide” — Rules and Guidance for Pharmaceutical Manufacturers and Distributors. GDP covers the quality system for distribution, personnel, premises and equipment, documentation, receipt and storage under proper conditions, transport, and the handling of returns, falsified medicines and recalls. A wholesale dealer must hold a Wholesale Dealer’s Licence and appoint a named Responsible Person accountable for GDP compliance, ensuring medicines are stored, transported and handled so their quality and integrity are maintained through the supply chain.
Scope & applicability
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.
Legal basis & how it acquires force
UK GDP requirements are set in the Human Medicines Regulations 2012, under which a wholesale dealer must hold a Wholesale Dealer’s Licence and comply with the GDP standard the MHRA enforces. Post-Brexit UK GDP mirrors the European Commission’s 2013/C 343/01 guidelines on good distribution practice, retained and applied in the UK. The Green Guide compiles the legislation and MHRA guidance in one reference, but the binding obligation is the Regulations and the licence conditions rather than the compilation itself.
Document structure
| Part | Covers |
|---|---|
| Quality management | The quality system for distribution and management of outsourced activities |
| Personnel | The Responsible Person, key personnel, training, and hygiene |
| Premises and equipment | Storage conditions, temperature control, and qualification of equipment |
| Documentation | Procedures and records for distribution activities |
| Operations | Receipt, storage, picking, supply, and handling of returns and falsified medicines |
| Transportation and complaints/recalls | Maintaining conditions in transit, and handling complaints, returns and recalls |
Key requirements
- 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
Implementation tips
- Track GB vs NI supply routes under the Windsor Framework when mapping licences and RP coverage
Revision notes
UK GDP remains aligned with EU GDP post-Brexit; monitor MHRA guidance for any future divergence.
International alignment
Post-Brexit UK GDP mirrors the EU good-distribution-practice guidelines 2013/C 343/01, so the UK requirement remains closely aligned with the EU standard, including the Responsible Person role and temperature-controlled storage and transport expectations. The alignment keeps UK and EU distribution requirements broadly comparable, while the binding legal basis in the UK is the Human Medicines Regulations 2012 as enforced by the MHRA.
MHRA GDP: frequently asked questions
Quick answers to common questions about MHRA GDP.
What is the “Green Guide”?
It is the MHRA’s consolidated reference — Rules and Guidance for Pharmaceutical Manufacturers and Distributors — that compiles the GDP (and GMP) legislation and MHRA guidance in one place. The binding requirement is the underlying Regulations, which the Green Guide reproduces.
What is the Responsible Person in UK GDP?
A named individual a wholesale dealer must appoint, accountable for ensuring GDP compliance — that a quality system is maintained and that medicines are handled so their quality and integrity are preserved.
Does UK GDP still follow the EU standard?
Yes. Post-Brexit UK GDP mirrors the EU good-distribution-practice guidelines 2013/C 343/01, with the legal basis being the Human Medicines Regulations 2012 enforced by the MHRA.