Guide · Compliance
Good Distribution Practice (GDP): what it means for your partners
The standard that guarantees a medicine arrives with the quality it left the factory with — explained without jargon.
When a medicine leaves the factory, responsibility for its quality does not stop at the gate. Good Distribution Practice — GDP — is the European standard ensuring that a medicine reaches the patient with the same quality it had when the manufacturer released it. For any company choosing a distributor, GDP is not a formality: it is the difference between a verifiable supply chain and one taken on trust.
The framework: the 2013 European guidelines
The current reference is the European guideline on Good Distribution Practice of medicinal products for human use (2013/C 343/01), applied in each member state by the national authority — in Romania, under the supervision of the National Agency for Medicines and Medical Devices (ANMDMR). Wholesale distributors operate under a wholesale distribution authorisation, and GDP compliance is the condition for keeping it.
The pillars of GDP, briefly
- Quality management system. Written procedures for every operation, clear responsibilities and a designated responsible person. Quality depends on processes, not on memory.
- Trained personnel. Everyone involved in handling medicines is trained regularly, and the training is documented.
- Qualified premises and equipment. Storage areas are temperature-mapped, monitoring equipment is calibrated and access is controlled.
- Documentation and traceability. Every movement of a product — receipt, storage, delivery — leaves a written trace: batch, expiry, quantity, recipient.
- Controlled operations. Incoming products stay in quarantine until verified; non-conforming products are physically segregated; stock rotates on a FEFO basis (first expired, first out).
- Complaints, recalls, returns. Procedures prepared in advance: who is notified, within what time, what gets blocked. In a batch recall, reaction speed depends on the quality of the records.
- Compliant transport. Storage conditions must be maintained on the road too — with qualified packaging, monitoring and clear rules for deviations.
- Partner qualification. The distributor verifies both suppliers (valid authorisation, legal provenance) and customers (entitlement to receive medicines).
Serialisation: the barrier against falsified medicines
The European Falsified Medicines Directive added a further layer of safety: the serialised unique identifier on each pack, verifiable against the European repository system. For distribution this means precise verification and decommissioning obligations in the situations the regulation defines — one more mechanism keeping the route of a medicine verifiable from manufacturer to patient.
How to verify a distributor, practically
Beyond declarations, compliance can be checked with simple questions: Do you hold a valid wholesale distribution authorisation, and for which operations? How are temperatures monitored in the warehouse and in transit, and who keeps the records? How did you handle your last batch recall or temperature excursion? Which documents accompany a delivery as standard? The answers — and above all the speed and precision with which they arrive — say more than any brochure.
Novus Pharma Distribution operates under Wholesale Distribution Authorisation no. 716D and holds GDP Compliance Certificate no. 011/2026/RO, issued by ANMDMR on 04.02.2026 following the inspection of 18.12.2025 and valid until June 2027 — verifiable in the EudraGMDP European database.
To see how we apply these principles in our own services, read the dedicated pages on pharmaceutical distribution and temperature-controlled logistics.
