Published: 24.09.2026. · GDP

GDP requirements for the distribution of medicines in Montenegro

Publisher: ConsultHQ

Good distribution practice (GDP) protects the quality and integrity of medicines as they pass through wholesale, warehouse and transport. The requirements do not end with a neat space: it is important to be able to prove where the medicine came from, under what conditions it was stored, to whom it was delivered and how any deviation was resolved.

Which framework should be followed?

European guidelines 2013/C 343/01 regulate good distribution practice for medicinal products for human use. In Montenegro, companies should follow valid domestic regulations and CInMED guidelines; the institute published guidelines for humane use in July 2026. Obligations depend on the specific role of the subject and the type of activity, so permits, contracts and the flow of goods are checked before the project.

The quality system connects people and processes

Clear responsibilities, authority of the responsible person, documentation control, training and change management are needed. The system should connect procurement, reception, storage, issuing, transport and complaints. If each service keeps unrelated records, it is difficult to reconstruct what happened to a particular batch.

Temperature and transport require demonstrable control

Storage conditions are determined by the product. The organization therefore assesses the space and equipment, monitors the temperature, calibrates the measuring devices and defines the reaction to the alarm. Temperature mapping makes sense when it shows where conditions in space differ; the record has no value if no one reacts to the deviation.

In transport, it is important to connect product requirements, route duration, packaging, means of transport and handover. The responsibility of the contractual partners should be clear, and the relevant evidence should be available even after delivery.

How are deviations and withdrawals handled?

The GDP system should include complaints, suspicion of falsified medicine, withdrawal, returned products and corrective measures. For each event, an impact assessment, a decision on the goods, notification and checking whether the measure prevented a recurrence are determined.

Where to start?

A practical first step is GDP gap analysis of the actual flow of goods and evidence. Then priorities are adjusted and implementation is checked. Take a look GDP implementation, support to wholesalers and transport of medicines.

Sources: CInMED: good practice guidelines; European Commission: GDP framework.

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