Transportation of Medicines: Regulations and Methods for Rapid Delivery
Spain exports 80% of its pharmaceutical production to the EU. In addition, it is one of the largest importers of Nolotil from Germany and active pharmaceutical ingredients (APIs) from China. However, the transportation and storage of pharmaceutical products require compliance with particularly strict requirements. Below, we will look at the key requirements for pharmaceutical logistics that help minimize risks at every stage of the supply chain.
How Does the Transportation of Pharmaceutical Products Differ from Other Types of Transportation?
The key factor is verifiable traceability at every stage of the route. The conditions defined by the manufacturer are not a recommendation: they must be followed and documented at every leg of transportation. This is critically important, as biochemical changes in a medicinal product are often impossible to detect with the naked eye, but they can have irreversible consequences.
What Regulations Govern the Transportation of Pharmaceutical Products?
The first standards for the distribution of medicinal products were developed by the WHO in the 1990s. In 1992, the European Union published its first directive on this issue. In 2013, the final version appeared — Guidelines 2013/C 343/01. Today, it is the reference document for intra-European transportation of pharmaceutical products and consists of 11 chapters, including:
- Quality management
- Personnel
- Premises and equipment
- Documentation
- Operations
- Self-inspections
- Transportation
- Brokers
Spain used the European guidelines as a basis. As early as 1994, Royal Decree 2259/1994 was already in force in the country, defining the sanitary conditions for pharmaceutical warehouses and their personnel. In 2013, after the new European guidelines were introduced, Royal Decree 782/2013 came into force, updating and expanding the regulatory framework for the transportation of pharmaceutical products.
Good Distribution Practices (GDP)
Good Distribution Practice is not a single separate regulation, but a set of control measures applied before, during and after the transportation of pharmaceutical products. They cover everything from distribution methodology to software validation. Their purpose is to ensure that the patient receives a medicinal product of the same quality as when it was manufactured.
Cold Chain and Temperature Control
Some medicinal products, including monoclonal antibodies or insulin, are extremely sensitive to temperature fluctuations. The cold chain is a process that ensures such products are transported and stored within a stable temperature range of 2 °C to 8 °C. According to regulatory requirements, maintaining this range without interruption is the distributor’s responsibility.
Documentation and Traceability
Behind every pharmaceutical shipment is a reliable traceability system. It makes it possible to determine exactly where the medicinal products are and under what conditions they are kept at every stage of the route. Data loggers with IoT connectivity or DataMatrix codes help ensure this.
Such tools make it possible to quickly detect incidents during storage or logistics operations. According to Royal Decree 782/2013, all procedures, contracts and records must be kept for at least five years and be available to health authorities. They may be submitted in writing — in paper or electronic format.
How Are Medicines Imported from Abroad?
In Spain, there are several channels for transporting medicinal products from abroad. They can be classified depending on the type of product:
| Product type | Prior authorization | Who can apply for import |
|---|---|---|
| Medicinal product registered in Spain | AEMPS | Importing laboratory |
| Active pharmaceutical ingredient (API) | Pharmaceutical border control | Manufacturer |
| Unregistered medicinal product | AEMPS | Hospital through the MSE procedure or an autonomous contact point |
| Blood-derived products / hemoderivatives | AEMPS | Same as for a registered medicinal product |
Customs Requirements and Health Inspections
Regardless of the type of supply channel, the shipment undergoes physical inspection and health control. The main customs requirements for placing medicinal products on the Spanish market are:
- Prior authorization from AEMPS.
- Health control at the border through the SIFAEX system.
- Import declaration indicating the shipment’s origin, destination and value.
- Storage in the customs area only at authorized facilities.
- Written confirmation of Good Manufacturing Practice (GMP) — mandatory for APIs from third countries, including India or China.
- Documented traceability.
Import Licenses and Permits
In Spain, a special license is required to commercialize pharmaceutical products. Licenses for registered medicinal products are processed electronically through the AEMPS IMH application.
If the medicinal product is intended for hospital use and is not registered in Spain, the application is submitted through the MSE application. Active pharmaceutical ingredients (APIs), in turn, must undergo border control. In the EU, a Marketing Authorisation for the medicinal product and GMP certificates — Good Manufacturing Practice — are also required.
How Are Pharmaceutical Products Transported?
Medicinal products are transported by different modes of transport: road, air, sea, or using multimodal solutions. It all depends on delivery times and the type of product.
Each transport scheme for the pharmaceutical industry has its own requirements under Good Distribution Practice. For example, trucks must be equipped with climate control systems. In air transportation, it is critically important to take sudden pressure changes into account. In sea transportation, humidity is the key parameter to control.
Ground and Air Transport
In Spain, road transportation of medicinal products remains the backbone of pharmaceutical logistics, supported in particular by a highway network of 15,825 km. At the same time, air transportation is used for biological products that require urgent delivery.
At Synex Logistics, we work with major pharmaceutical companies, including Acino. We transport their shipments by road from Switzerland to Spain and across Europe. For this, we use isothermal trucks that help preserve the integrity of the cargo throughout the entire route.
Emergency transport of pharmaceutical products
Urgent transportation of pharmaceutical products is used when a medicinal product needs to reach the patient immediately, or when delivery deadlines are extremely tight. These deadlines are defined by the manufacturer for each product based on its stability studies.
| Product | Optimal temperature | Time without refrigeration |
|---|---|---|
| Vaccines | 2-8°C | Less than 1 hour |
| Category C thermolabile products | ⁓ 25°C | Up to 48 hours |
| Medicinal products stored at room temperature | 15-25°C | No strict limit if the packaging maintains the required temperature range |
Based on our experience, there is no single universal method for fast delivery. Everything depends on the distance and the type of product. At the local or national level, the fastest solution is isothermal vans or refrigerated trucks. If the delivery is international, we opt for multimodal transportation — by air and road.
How are medications stored in logistics warehouses?
A warehouse in pharmaceutical logistics is usually divided into four zones:
- Controlled conditions area: temperature, humidity and lighting.
- Security area: for psychotropic substances, with restricted access.
- Expired products area: for medicinal products past their expiry date.
- Quarantine area: for products pending inspection or rejected products.
Medicinal products are stored in batches identified by number. In addition, to improve the efficiency of warehouse automation in pharmaceutical logistics, stacker cranes, IoT systems and real-time monitoring sensors are used.
How to choose transportation companies for shipping pharmaceutical products?
Choosing a logistics partner is not a formality. The distributor must be ready to:
- Provide certified transport.
- Ensure real-time cargo tracking.
- Manage all documentation independently.
- Have facilities certified by AEMPS.
- Handle complex cross-border operations.
- Guarantee continuity of service at critical moments.
Yes, many international companies that transport pharmaceutical products offer adapted vehicles. However, not all of them have the proper level of control and process digitalization. We should keep this in mind.
Ship your medications with SYNEX Logistics
Need to transport pharmaceutical products from China, India, Asia, Latin America or Europe? Tell us the details of your shipment, and we will take care of the rest: the right transport, logistics warehouses, temperature control, traceability, customs clearance and delivery. Contact SYNEX Logistics.
FAQ
It is the Spanish Agency of Medicines and Medical Devices, authorized to supervise and control medicinal products and their distribution in Spain.
Yes, provided that the required storage conditions for each product are maintained independently, for example by using separate compartments validated for the relevant temperature range.
The affected batch must be placed in quarantine immediately. After that, a risk assessment must be carried out, on the basis of which the integrity and quality of the medicinal product can be confirmed.
