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Industries · Pharmaceuticals

Pharmaceuticals — dangerous goods hide in the cold chain

A pharma warehouse ships more than medicines — ethanol and isopropanol for production, samples on dry ice, clinical waste on the return run. GDP auditors check the temperature, the road inspector checks ADR. We keep both worlds consistent.

Dry ice is almost free under ADR — yet 5.5.3 still demands ventilation and marking, and few people know it.

Three ways your goods can travel

The same product can go as limited quantities, under the 1.1.3.6 partial exemption or in full ADR — the classification and the packaging decide.

Limited quantities (LQ)

Small inner packagings within the column 7a limit, up to 30 kg gross — the goods travel with the LQ diamond, free of most other ADR provisions (Chapter 3.4).

Partial exemption (1.1.3.6)

Below the transport category threshold per transport unit — no orange plates, no written instructions, no ADR driver certificate (the list in 1.1.3.6.2).

Full ADR

Above the thresholds the goods travel under the full set of rules — transport document, plates and labels, equipment, trained crew and every participant duty.

The same ethanol travels three ways — litre bottles go as LQ with the diamond, a pallet of canisters may fit under 1.1.3.6, and an IBC for production ships in full ADR with an ADR driver.

Who answers for what

ADR splits the duties among the participants of the carriage. These are the roles your company typically holds — with the exact ADR paragraphs.

ADR 1.4.2.1

Consignor

Hands over only consignments that conform to ADR — classified, authorized, in approved packagings, with the transport documents furnished to the carrier.

ADR 1.4.3.2

Packer

Follows the packing and mixed-packing conditions and, when preparing packages for carriage, the marking and labelling requirements.

ADR 1.4.3.1

Loader

Checks packagings for damage before handing over, observes the mixed-loading prohibitions and the separation from foodstuffs.

ADR 1.4.3.7

Unloader

Compares the transport document with what actually arrived before unloading — returns and clinical waste flows included.

For each of these roles the company needs an appointed safety adviser (1.8.3.1) — ours works on subscription.

About the DGSA

What a mistake costs

Ethanol shipped without the entry or an untrained packer — the sums below are what national law charges for it.

Sanctions are national — checks are European

Every ADR country sets its own fines for dangerous goods violations. Roadside checks follow one European standard — Directive (EU) 2022/1999 with a common list of infringements by risk category. Open your country to see the authorities and the exact amounts.

Find your country

And beyond the fines

  • A vehicle stopped at a roadside check — with your customer waiting for the delivery
  • An incident with an untrained crew — and an insurer reading the file closely
  • Violations on record — and inspections coming back more often

What the law expects from you

ADR duties come first — and your industry carries its own EU rules on top.

Under ADR

  • Classify every product before it is handed over for carriage
  • Train everyone who touches dangerous goods (Chapter 1.3)
  • Appoint a safety adviser — carriers, consignors, loaders, packers alike
  • Mark, document and equip every consignment correctly

EU rules of the industry

The industry in numbers

€464 bn

pharmaceutical production in Europe per year (2024)

Source · EFPIA

≈4%

of EU road freight is dangerous goods (2020)

Source · Eurostat

Is this about you?

If even one line matches your operation — it is worth a conversation.

  • Samples leave by courier on dry ice, and nobody marks the box
  • Ethanol and isopropanol arrive at production in canisters and IBCs
  • Return runs collect clinical waste as if it were ordinary rubbish
  • The GDP audit is passed, and nobody in the company closes the ADR questions
  • Nobody in the company is formally appointed as the safety adviser

Questions from the industry

Have a different question?

Contact the consultant
Medicines are not dangerous goods — why does ADR concern us?

Finished medicines mostly are not, but the flows around them are — solvents for production, dry ice under samples, clinical waste on the way back. The regime is set by classification, not by the industry sign on the door.

The courier says dry ice is no problem — is that true?

On the road it is nearly exempt, but the duties of 5.5.3 remain — ventilation of the vehicle and marking of the package. The consignor answers for both, and the same parcel in the air network lives under far stricter rules.

We passed the GDP audit — is ADR covered by that?

No. GDP governs the quality of distribution, ADR governs the safety of carriage — different authorities, documents and training. Compliance in one does not transfer to the other.

Where do we start?

Send the list of everything that leaves your site — we prepare the cargo instruction with the transport document entry from €50 per document and show which regime each flow falls into. From there the subscription from €50 plus €10 per transport covers the adviser, the platform and the training of your people.

Tell us how your goods move

Within one working day you get a clear answer — what applies to you, what does not, and what it costs to be in order.

Request a proposal

Request a proposal for your operation

Describe how dangerous goods move through your operation — a certified consultant looks at the flows, not a manager.