Good distribution practice for medicines in the UK and EU
Good distribution practice protects medicine quality during storage and supply. Learn UK and EU controls, how GDP differs from GMP, and certificate checks.
Good distribution practice (GDP) maintains medicine quality throughout the supply chain, from the manufacturing site to the pharmacy or another authorised supplier to the public. It is part of quality assurance and controls sourcing, storage, handling and transport, including records, returns and recalls. The EU GDP guidelines set out these controls for human medicines.
For UK wholesalers, MHRA requires GDP compliance and inspections through its medicines licensing system. Its GMP and GDP guidance continues to reference the EU guidelines. This guide covers finished human medicines in the UK and EU, rather than a global certification scheme.
What the GDP guidelines cover
The EU human-medicines guideline is Commission Guidelines of 5 November 2013, 2013/C 343/01. Wholesale distribution includes procuring, holding, supplying or exporting medicines, but excludes supplying them to the public. A manufacturer distributing its own products must also comply with GDP. Its manufacturing authorisation covers distribution of products within that authorisation's scope. See the guideline introduction and EMA's explanation of wholesale authorisation.
Scope matters. EMA identifies separate GDP guidelines for active substances. Don't apply this finished-medicines guide unchanged to APIs, veterinary medicines or medical devices. Use the relevant legal framework and guidance for the product and activity concerned.
What GDP compliance requires in practice
The GDP guidelines cover management responsibilities, staff training and authorised trading partners as well as warehouse conditions. They also require procedures for handling problems.
Put responsibilities and training into the quality system
Document responsibilities, processes and quality-risk controls. Investigate deviations, assign corrective and preventive action (CAPA), and control changes. Management must resource and review the system. These duties sit in Chapter 1 of the EU guidelines.
The wholesaler must designate a Responsible Person (RP) with the competence and qualifications required by national law. A pharmacy degree is desirable under the guideline, not universally mandatory. The RP needs GDP knowledge and training and must be continuously contactable. They can delegate duties, but not responsibilities. Their duties include supplier approval, recalls, training and decisions on returned stock. See section 2.2.
GDP training must be initial and continuing, with content suited to each role. Written programmes must cover falsified-medicine awareness and specific handling needs where relevant. Keep training records and periodically assess effectiveness. Section 2.4 does not prescribe one annual refresher interval for everyone.
Check suppliers, customers and transaction records
Approve suppliers before buying medicines. Verify a wholesale supplier's authorisation and GDP compliance, then recheck periodically. Customers must be authorised wholesalers or people authorised or entitled to supply medicines to the public. Their entitlement also needs periodic checks. These are separate controls under sections 5.2 and 5.3.
Keep approved, current procedures and record transactions when they occur. Records include the date, medicine, quantity and counterparties. The guideline expressly requires batch numbers at least for products bearing safety features. That wording does not remove other applicable batch-traceability duties. Retain documents for the national-law period, with a minimum of five years, under section 4.2.
Control storage and transport conditions
Premises must be secure, clean, dry and suitable for the stock. Physically segregate falsified, expired, recalled and rejected medicines. Use first-expiry-first-out stock rotation, with documented exceptions. These requirements appear in Chapter 3 and section 5.5.
Map storage areas before use under representative conditions, then position temperature monitors using the results. Repeat mapping following a risk assessment or significant changes. Calibration intervals for storage temperature monitors depend on risk and reliability. There is no single annual mapping rule in sections 3.2.1 and 3.3.
For transport, maintain the conditions specified by the manufacturer or packaging. Assess routes and protect medicines against breakage, theft, adulteration and unacceptable temperatures. Use qualified equipment for temperature-sensitive products, and investigate and report excursions. Maintain and calibrate transport temperature-monitoring equipment at least once a year. See Chapter 9.
Don't assign every medicine a 2–8°C range. The required conditions depend on the product. Storage and transport controls must preserve those specified conditions, rather than follow a generic cold-chain label. Both storage and transport requirements depend on the medicines being handled.
Prepare for returns, recalls and outsourced work
Assess returned medicines through a written, risk-based process before returning them to saleable stock. Cold-chain returns need documented evidence of appropriate conditions. Any deviation needs an assessment of product integrity. A sealed pack alone doesn't establish its storage history. See section 6.3.
Recall procedures must permit prompt action at any time, supported by accessible distribution records. Evaluate recall arrangements at least annually. Notify the competent authority and marketing-authorisation holder immediately about falsified or suspected falsified products. These duties appear in sections 6.4 and 6.5.
Outsourcing does not transfer away the contract giver's responsibility. Written contracts must define duties, and the contract giver must assess contractors and assure compliance through contracts and audits. Self-inspection must cover GDP within a defined timeframe, record findings and follow up CAPA. External audits do not replace it. See Chapters 7 and 8.
GDP versus GMP
GMP concerns manufacturing medicines to a consistent quality appropriate to their intended use and authorisation or specification. GDP concerns obtaining medicines through the licensed supply chain and preserving quality during distribution. MHRA explains both responsibilities.
| Question | GMP | GDP |
|---|---|---|
| What activity does it address? | Manufacturing | Sourcing, storage, handling and transport |
| What is the quality task? | Consistently produce medicine of the required quality | Maintain medicine quality through distribution |
| Can one business need both? | Yes, where its activities include manufacturing and distribution | Yes, including manufacturers distributing their own products |
The activities can overlap. Avoid treating GMP and GDP as two regimes separated by a single handover event. Manufacturing compliance does not cancel distribution duties. The EU GDP introduction expressly includes manufacturers distributing their own medicines.
GDP training, licences and certificates
"GDP certification" can mean different documents. Check what the document actually demonstrates before accepting it as evidence.
| Document | What it demonstrates | What it does not replace |
|---|---|---|
| Training course certificate | Attendance or completion evidence for training | Role competence assessment, a wholesale authorisation or a regulatory site certificate |
| Wholesale distribution authorisation | Legal authorisation for the activities within its scope | Evidence of ongoing GDP compliance |
| Regulatory GDP certificate | Inspection-related evidence of compliance | A wholesale authorisation or continuing compliance duties |
These distinctions follow the GDP training requirements and MHRA's licensing and inspection process. A course certificate alone does not establish that someone meets national RP requirements. Choose training for the work performed, keep records and assess whether it was effective.
In UK human-medicines wholesale licensing, the authorisation is called a WDA(H). MHRA describes licensing requirements and limited exemptions. Don't assume every medicine movement or pharmacy activity automatically requires a separate authorisation. Check the MHRA licensing guidance against the proposed activity.
For EU checks, EudraGMDP holds authorisations, compliance certificates and non-compliance information as distinct records. Check the entity, site, authorised scope and dates, alongside any non-compliance record. A certificate badge is not enough.
For UK records, follow the lookup route in MHRA's current licensing guidance. It directs readers to MHRA GMDP and identifies EudraGMDP for licences issued before 1 January 2021. EudraGMDP is not the sole current UK lookup route.
Does this cover FDA requirements?
This UK/EU guide does not establish US compliance under the separate DSCSA framework. The FDA's July 2022 trading-partner draft guidance is marked "not for implementation", not current compliance instructions.
RegAffairs AI's answer on good distribution practice explains the medicines GDP requirements with source citations.