Transporting medicines: what Good Distribution Practice requires, article by article

Who is liable while the goods are in the truck

The legal obligation does not move to the carrier once the doors close. Art. 40(1) places it squarely on the wholesale distributor: it is their responsibility to protect the medicines against deterioration, falsification and theft, and to keep the temperature within acceptable limits throughout the transport.

• Whatever the mode of transport, it must be possible to demonstrate that the medicines were not exposed to conditions that could compromise their quality, and the transport is planned on a risk-based approach (art. 40(2)).
• Where the transport is carried out by a third party, the contract in force must cover the requirements of chapter VIII, and it is the distributor who must inform the carrier of the conditions applying to that shipment (art. 41(9)).
• In practice that means that without written instructions I have nothing to comply with. I ask for the temperature range, the excursion procedure and the contact person before loading, not after something goes wrong.

Civil liability for the goods is a separate matter and is judged under the CMR Convention. On its cap, with figures, in the second-to-last section.

The wholesale authorisation and the myth of "GDP-certified transport"

A carrier does not need a wholesale distribution authorisation, and cannot obtain a good distribution practice certificate either. Both statements have an article behind them:

• Art. 2(2) of the Norms approved by Health Minister's Order no. 131/2016 lists the operations for which the authorisation is required: procurement or supply transactions, holding (storage) and handling, export. Transport is not on the list.
• The guide defines transport as moving medicines from one point to another without storing them for unjustified periods of time (art. 2 pt. 5). Holding, by contrast, is defined as storage (art. 2 pt. 4) — and that does need an authorisation.
• The good distribution practice certificate is issued by ANMDMR to inspected units, within 90 days of the inspection, in the European model, and entered in the European EudraGMDP database (chapter III, art. 23 and art. 28 of the Norms). A carrier does not enter that procedure.

So "GDP-certified transport" does not exist as a document in a carrier's name. What does exist, and what a serious distributor asks for, is a contract under chapter VIII and a passed audit. If someone shows you a carrier's own GDP certificate, ask for its number and look it up in EudraGMDP.

What the distributor checks before the first shipment

Chapter VIII treats transport as an outsourced activity. The guide's Romanian wording calls the distributor the "contract supplier" and the carrier the "contract beneficiary" — the reverse of what most people expect. What follows from it:

• An audit of the carrier must be carried out before the outsourced activity begins and whenever that activity changes; the frequency is set on a risk basis, and audits must be allowed at any time (art. 36(2)).
• The carrier must have suitable premises, equipment, procedures, knowledge and experience, and competent staff for the activity required (art. 37(1)).
• It may not entrust the shipment to a third party without the distributor's prior assessment and approval and without an audit of that third party (art. 37(2)). On a GDP shipment the load does not go to the first free truck found on an exchange.
• It must pass on to the distributor any information that may affect the quality of the product (art. 37(4)).
• In the site master file filed with ANMDMR, the distributor lists every contract beneficiary, transport companies included, with name, address, phone and a short description of the activity (annex no. 3, pt. 1.7 of the Norms).

That last point is why a distributor does not change carriers overnight: my name sits in their file, and a deficiency found at my end becomes a deficiency in their inspection report.

Temperature: the limits, the equipment and the proof

The limits are set neither by the carrier nor by the distributor. Art. 41(1) says that during transport the storage conditions are kept within the limits defined by the manufacturers or indicated on the outer packaging. The ranges you find printed on the box, as examples:

• A risk assessment of the delivery routes is carried out to determine where temperature control is needed. Monitoring equipment in vehicles and containers must be maintained and calibrated at regular intervals, at least once a year (art. 41(5)).
• Dedicated vehicles and equipment are used where possible; where they are not, there must be procedures guaranteeing that quality is not compromised (art. 41(6)).
• On controlled-temperature vehicles, temperature mapping is carried out under representative conditions, taking seasonal variation into account (art. 43(4)).
• Cool packs must not be in direct contact with the product, staff are trained on the seasonal configurations of insulated boxes, their reuse is controlled, and frozen packs are physically separated from chilled ones (art. 43(6) and (7)).
• On request, the records showing that temperature conditions were kept are made available to the customer (art. 43(5)).

"Store at 2 °C – 8 °C"

Cold chain. It needs an active unit, not just insulation, and continuous recording

"Store below 25 °C", or below 30 °C

An upper limit, not a range. In summer that becomes the real problem; in winter, freezing does

"Do not freeze"

A lower limit. An insulated van without a refrigeration unit can be enough over short distances, if the risk assessment supports it

No temperature statement

Not the same as no rules: the rest of chapter X still applies, including the delivery and transport-hub rules

The standards an audit usually asks about are EN 12830, 2018 edition, for temperature recorders — it covers the whole recording system, over the −80…+85 °C range — and EN 13486, 2023 edition, for periodic verification. Neither is a "GDP certificate": they are equipment standards, and the requirement in the guide remains calibration at least once a year.

Route rules that are not negotiable

The part of chapter X most people discover on their first refused delivery. These are not customer preferences, they are the text of the guide:

• Deliveries are made to the address stated on the dispatch note, entrusted to the consignee or left at their premises. Medicines must not be left at other addresses (art. 41(7)). So nothing is unloaded "at the gate", at another company, or at a collection point.
• For emergency deliveries outside normal working hours there must be designated persons and written procedures available (art. 41(8)).
• If the route includes unloading and reloading, or in-transit storage at a transport hub, special attention goes to temperature monitoring, hygiene and the security of any intermediate storage (art. 41(9)), and the duration of temporary storage is kept to a minimum (art. 41(10)).
• A transport hub is defined in the Norms as the place on the route where unloading, loading or in-transit storage of up to 24 hours may take place (art. 1(k)).
• Adding or removing a transport hub must be notified to ANMDMR in advance, together with the request for a new authorisation or annex (art. 12 of the Norms).

Those last two points are why, on a pharmaceutical shipment, an improvised cross-dock is not a logistics question but an authorisation one. Either the intermediate warehouse is a transport hub declared in the distributor's authorisation, or the goods have no business being there — and beyond 24 hours it is no longer transit.

A temperature excursion: what happens to the goods afterwards

• If a deviation occurred during transport — a temperature limit exceeded or damage to the product — it must be communicated to the distributor and to the recipient of the goods, and there must be a procedure for investigating and handling it (art. 41(2)).
• Goods that have left the distributor's premises are returned to saleable stock only if they are inside their unopened and undamaged secondary packaging, in good condition, not expired and not recalled (art. 32(2)(a)).
• And only if the customer demonstrates that the medicines were transported, stored and handled in accordance with their specific storage requirements (art. 32(2)(c)).
• For returns from customers who no longer hold a wholesale distribution authorisation, or from pharmacies, the guide requires an acceptable time limit and gives 10 days as the example (art. 32(2)(b)).

Read together, those articles say something simple: the temperature record and the intact packaging decide whether a refused pallet goes back into stock or is destroyed. With pharmaceutical goods the difference is usually measured in tens of thousands of euros — which is why downloading the recorder data and photographing the seal are not formalities.

Narcotics, psychotropics, radioactive materials

If the goods fall into any of the categories below, I tell you before quoting, because they are not solved with an available truck and good will:

• For medicines requiring special conditions, such as narcotic and psychotropic substances, there must be additional control systems for the delivery and a protocol to address cases of theft (art. 43(1) of the guide).
• Law no. 339/2005 defines the carrier as the person authorised for the purpose of carrying out the transport (art. 2(f)), and the transport as a quantity authorised for a single transport operation (art. 2(e)). This is not an authorisation obtained on the spot.
• The transport is carried out accompanied by the documents required by law, with the preparations in containers bearing tamper-proof seals that allow inspection, and any circumstance that would permit illegal trafficking is reported to the authorities as quickly as possible (art. 33(2) of the same law).
• Medicines containing highly active or radioactive materials are transported in dedicated containers and vehicles, with measures complying with international agreements (art. 43(2) of the guide) — for class 7, the ADR rules.

How much of a pharmaceutical pallet's value the CMR covers

This is where the arithmetic most often breaks, because pharmaceutical goods carry a value per kilogram far above average, while the liability cap is calculated per kilogram, not on value:

The CMR cap

8.33 SDR per kilogram of gross weight short (art. 23(3) of the CMR Convention)

What one SDR is worth

Around 1.20 euro on 30 September 2026; the rate is published daily by the International Monetary Fund

So, in euros

Roughly 10 euro per kilogram of goods missing

A 300 kg pallet

About 2,500 SDR, that is some 3,000 euro — usually a fraction of the pallet's value

How the cap is raised

A declared value in the consignment note (art. 24) or a special interest in delivery (art. 26), against an agreed surcharge

The alternative

Cargo insurance, taken out before loading, not after

On pharmaceutical goods I recommend cargo insurance rather than declaring the value: at high values the surcharge a carrier asks for art. 24 ends up dearer than a policy, and the policy also covers risks for which the carrier is relieved of liability by art. 17(2).

What to send me so I can give you a price and a compliant shipment

Five lines, and the quote comes back with everything that belongs in it rather than with surprises at loading:

• What the goods are and what the outer packaging says about storage — the exact wording, not "it needs to be cold".
• The number of pallets, the weight per pallet, and whether they can be stacked.
• Whether you need the temperature record at delivery, and in what format you want it.
• The loading and unloading addresses with their time windows, and whether the route needs any transport hub.
• Whether the goods contain narcotic or psychotropic substances or ADR classes, and who the declarant is for the UIT code in RO e-Transport.

With those I send you the price, the vehicle type I will allocate and the documents that will travel with the goods. If you are a wholesale distributor and need to audit me first, say so in your first message: that is a normal step, not an obstacle.