A medicine can be manufactured perfectly and still reach the patient compromised. Good Distribution Practice governs everything that happens in between — and it is enforced far more actively than many distributors expect.
The governing text is the Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01), published in the Official Journal on 23 November 2013 and applicable from 24 November 2013. Despite persistent rumours to the contrary, it remains the current GDP guideline — there is no successor and no revision in progress. Active substances are covered separately by the 2015 guidelines.
The Responsible Person
Every wholesale distribution authorisation holder must designate a Responsible Person. Note that the EU text makes a pharmacy degree desirable, not mandatory — the binding qualifications are those of the Member State, so Greek requirements govern Greek authorisations. The RP’s duties include maintaining the quality system, ensuring training, coordinating and promptly performing recalls, approving suppliers and customers, ensuring self-inspections, and deciding on returned, rejected, recalled and falsified products.
Qualify both ends of the chain
Chapter 5 is unambiguous: source only from holders of a wholesale distribution or manufacturing authorisation, and supply only to those authorised to receive. That means a documented procedure for selection and approval, genuine due diligence at onboarding, quality agreements, and periodic rechecks — verifiable through national authority registers and EudraGMDP.
Transport is your responsibility
Under Chapter 9, the supplying distributor is responsible for protecting products against breakage, adulteration and theft, and for maintaining temperature conditions in transit. Regardless of the mode of transport, you must be able to demonstrate that products were not exposed to conditions that could compromise them. A risk-based approach is required, container selection must account for external temperature extremes and maximum transit time — including time sitting at customs — and shipping containers must be sealed.
Falsified medicines
The Falsified Medicines Directive and its Delegated Regulation require a unique identifier and anti-tampering device, verified through the European Medicines Verification System. Distributors sit squarely inside that verification chain.
What is actually changing
The real development is not a GDP rewrite. It is the EU pharmaceutical package, which reached political agreement in December 2025 and will replace Directive 2001/83/EC — the legal foundation on which the GDP guidelines rest. Distributors should watch that, not phantom consultations.
How PQRA helps
PQRA supports wholesale distribution authorisations, Responsible Person duties, supplier and customer qualification, and GDP audit readiness in Greece.
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