Who is authorized to transport medications to pharmacies? Domestic transportation of medications, between pharmacies, and across the border

The transport of medications to pharmacies, hospitals, and wholesalers is strictly regulated. It’s not just about who is transporting them, but also at what temperature, in what type of vehicle, and with what documentation. In this guide, we’ve compiled the most important rules for transporting medications in one place: who can transport medications to pharmacies, how medications are transported between pharmacies, what you need to know about transporting medications across borders, and how to vet a carrier before you hire them for your first shipment.

Who is allowed to transport medications to pharmacies?

Pharmacies purchase medicinal products from pharmaceutical wholesalers. The wholesaler is responsible for ensuring that the medication reaches the pharmacy without any loss of quality. The wholesaler can arrange transportation in two ways:

• własnym transportem - the warehouse’s vehicles and drivers, who are covered by its quality system,
• by an outside carrier - based on a written agreement in which the wholesaler specifies the conditions of transport (temperature, time, documents, procedures in case of deviations). The Good Distribution Practice Guidelines refer to these as commissioned activities.

In practice, this means that a transportation company may also transport medications to pharmacies, provided it operates in accordance with GDP (Good Distribution Practice) requirements and has been approved by the client. The carrier does not assume the wholesaler’s responsibility for the quality of the medication, but is responsible for the conditions it promised in the contract.

A GDP certificate for a transportation company is issued by an independent certification body following an audit. It does not replace the wholesaler’s approval of the carrier, but it serves as strong evidence to the wholesaler that the necessary procedures, vehicles, and training are in place. We describe this in detail in the post What permits are required to transport medications?.

What regulations govern the transport of medications?

• Pharmaceutical Law - specifies who may engage in the distribution of medicinal products (wholesalers, pharmacies) and under what conditions.
• Regulation of the Minister of Health of March 13, 2015, on the Requirements for Good Distribution Practices - Transposes GDP requirements, including transportation rules, into Polish law.
• EU Guidelines on Good Distribution Practices (2013/C 343/01) - Chapter 9 deals with transportation, and Chapter 7 with outsourced activities, specifically the collaboration between the warehouse and the carrier.

Supervision of the distribution of medicines is carried out by the Main Pharmaceutical Inspectorate and provincial pharmaceutical inspectors. You can find the latest announcements on the website GIF.

Requirements for transportation of medicines

Temperature

The medication must be transported under the conditions specified by the manufacturer. Most often, these consist of two ranges:

• +15°C to +25°C - most medications (controlled at room temperature),
• +2°C to +8°C - insulin, vaccines, biologics, and other products that require a cold chain.

The temperature must be measured and recorded throughout the entire route, not just during loading and unloading. We discuss the refrigeration regime in more detail in our post about transporting vaccines at a temperature of 2-8°C.

Vehicle

• isothermal or refrigerated units selected for the temperature range,
• a vehicle certified for the transport of medications (e.g., temperature mapping of the cargo area),
• calibrated temperature loggers and an alarm that triggers when the range is exceeded,
• A clean cargo area, secured against unauthorized access and damage to the goods.

For typical deliveries to pharmacies and wholesalers, a van up to 3.5 t is usually sufficient - we discuss when this is a good solution in our post transport leków busem.

People and Procedures

• a driver trained in GDP principles and procedures for handling temperature deviations,
• a written procedure in case of a cooling system failure, an accident, or a delay,
• Inspection of the condition of packaging and documents upon receipt, and confirmation of delivery.

Documentation for the Transport of Medications

• a shipping document listing the products, the shipper’s and recipient’s information, and the date of shipment (for international transport, a CMR consignment note),
• temperature data from the data logger for the entire route,
• a report on any deviations and the actions taken,
• confirmation of receipt by a pharmacy, wholesaler, or hospital.

Well-maintained records serve as proof that the medication was transported properly - they come in handy during pharmaceutical inspections and when filing a complaint.

Transport of Medications Between Pharmacies (Inter-pharmacy Transfers)

Inter-pharmacy transfers involve the movement of medicinal products between two pharmacies - most often within a single chain, within a hospital, or when there is an urgent shortage of a medication for a patient.

Before arranging such a shipment, check the legal basis. A retail pharmacy is not a wholesaler: The Pharmaceutical Law (Article 86a) restricts to whom and for what purpose a pharmacy may sell a drug, and the sale of a drug to another pharmacy or a wholesaler is, as a general rule, prohibited. Interpretations of transfers within a single chain may vary, so the decision is made by the pharmacy manager; if in doubt, it is advisable to consult the provincial pharmaceutical inspector. The carrier is responsible for how the medication is transported - not for whether the transfer is permitted.

Transportation between pharmacies is subject to the same GDP rules as delivery from a wholesaler:

• a temperature that meets the product's requirements (15-25°C or 2-8°C), measured throughout the entire route,
• for refrigerated goods - a refrigerated van or passive packaging (insulated boxes, cooling packs) as an additional safeguard,
• a document listing the names and quantities of the products, the details of the shipping and receiving facilities, the date and time of transport, and temperature readings.

A break in the cold chain, even for a short time, may result in the medication having to be recalled - which represents a real loss for the pharmacy and a risk to the patient.

Transporting Medications Across the Border

In the European Union

The same GDP rules apply throughout the EU, and the distribution of medicines is regulated by Directive 2001/83/EC. There is no customs clearance for commercial transport between EU countries, but transport documents (CMR consignment note), commercial documents from the shipper, and continuous temperature records are required. A longer route means a longer period during which the proper temperature must be maintained - this must be taken into account when planning.

Export of Medicines from Poland

Some medications are included on the list of products at risk of becoming unavailable in Poland, which is published by the Minister of Health. A business that wishes to export such a drug abroad or sell it to a foreign company must first notify the Chief Pharmaceutical Inspector (Article 37av of the Pharmaceutical Law). The Chief Pharmaceutical Inspector has 30 days to raise any objections. The transport of products on the list must also be reported in the Road Freight Transport Monitoring System (SENT). The shipper is responsible for these reports, but the carrier should know whether they apply to its cargo.

Outside the EU and Drugs Subject to Special Control

Outside the European Union, customs clearance and the regulations of the destination country apply. Medications containing narcotic or psychotropic substances require separate import and export permits issued by the GIF - without them, these medications may not be transported across the border.

Carrying your own medications in your luggage while traveling is a different matter - the rules depend on your destination country and the type of medication. This guide covers commercial transportation.

How to Check a Medication Carrier Before Ordering a Shipment

• Certificates - Ask for a current GDP certificate, and for refrigerated vans, also the vehicle’s ATP certificate, and check the expiration dates.
• Kwalifikacja pojazdów - Ask about temperature mapping and the calibration of data loggers.
• Zapis temperatury - Determine in what format you will receive the trip report.
• Emergency procedures - What happens in the event of a generator failure, an accident, or a delay, and who notifies the client.
• Insurance - Check the carrier’s liability insurance coverage amount and compare it to the value of the cargo.
• Umowa - Document the terms of transport and the scope of liability before the first shipment departs.

If you're interested in the costs, read on, What Factors Determine the Rates for Transporting Medications?.

Transport of Medications by SLAWA sp. z o.o.

We realize Pharmaceutical transport in compliance with GDP by vans up to 3.5 t - in Poland and to other European countries. We transport medications within temperature ranges of +2°C to +8°C and +15°C to +25°C, with temperature monitoring and logging. We hold a GDP certificate issued by GQ, a quality management system compliant with ISO 9001:2015, and OCP insurance coverage of 1 million EUR. We handle deliveries to pharmacies and wholesalers, transfers between facilities, and international shipments.

Frequently asked questions

Who is allowed to transport medications to pharmacies?

A pharmaceutical wholesaler using its own transportation or a carrier contracted by the wholesaler to provide transportation services under a written agreement. The carrier must operate in accordance with GDP requirements and be approved by the client.

Does a pharmaceutical carrier need to have a GDP certificate?

The carrier must comply with GDP requirements. A certificate from a certification body confirms that the carrier meets these requirements, and in practice, wholesalers and manufacturers usually require it.

At what temperature are medications transported?

At the temperature specified by the manufacturer - usually +15°C to +25°C, and for refrigerated medications, such as insulin and vaccines, +2°C to +8°C. The temperature must be recorded throughout the entire route.

Can a pharmacy transfer medications to another pharmacy?

Pharmaceutical law generally prohibits pharmacies from selling medications to other pharmacies or wholesalers, with exceptions as described in the regulations. The legal basis for such a transfer is assessed by the pharmacy manager, and the transport itself must comply with GDP guidelines.

Do you have to report taking medications out of Poland?

Yes, if the drug is on the list of products at risk of becoming unavailable. In that case, the business must notify the GIF of its intention to export the product, and the GIF has 30 days to object.

Related articles

• What Licenses Are Required to Transport Medications? Requirements and Certifications
• Professional Transportation of Medications - Rates and Requirements
• Transporting Medications by Van
• Vaccine Transport - Cold Chain at 2-8°C
• Disposal of Medications - Procedures and Regulations