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      Pharma & Healthcare Logistics

      Your Complete Guide to Life Sciences & Medical Logistics: Regulations, Best Practices & Quote Requests

      EU Rules for Shipping Pharma Products

      Shipping pharmaceuticals to and from the EU is subject to a complex regulatory framework designed to ensure product safety and efficacy throughout the supply chain.

      Key regulations and examples include:

      Good Distribution Practice (GDP):

      • Chapter 3 (Premises and Equipment): Requires premises to be fit for purpose, e.g., temperature-controlled storage areas must have calibrated monitoring systems with alarms for deviations.
      • Chapter 9 (Transportation): Specifies vehicles must be suitable for maintaining product quality, e.g., refrigerated trucks for temperature-sensitive goods with validated loading/unloading procedures.

      Falsified Medicines Directive (FMD):

      • Unique Identifier: Each pack of prescription medicine must have a unique serial number, checked against a database before dispensing to verify authenticity.
      • Tamper-Evident Features: Packaging must have features like holographic stickers or specific closures to indicate if it's been opened.

      More about the FMD on this page.

      Temperature Control:

      • EU GDP Guidelines Annex 2: Details temperature ranges for different products, e.g., 2-8°C for vaccines, -70°C for some biopharmaceuticals.
      • Continuous Monitoring: Data loggers in shipments record temperature at set intervals, and this data must be analyzed to prove the cold chain wasn't broken.

      Customs Regulations:

      • EU Tariff Classification: Pharmaceuticals have specific codes (e.g., HS code 3004 for medicaments) and misclassification can lead to delays or incorrect duties.
      • Import Licenses: Certain narcotics or high-risk medicines may need prior authorization from the country's health agency, in addition to standard customs clearance.

      Security:

      • TAPA TSR (Transported Asset Protection Association - Trucking Security Requirements): A certification involving vehicle security features (locks, alarms), driver training, and route planning to minimize theft risk.
      • Serialized Shipments: For high-value products, each unit may have a unique serial number tracked throughout the journey, making stolen goods harder to resell.

      Specific Product Regulations:

      • Controlled Drugs: Stricter record-keeping, secure storage, and potentially escorts for transport may be mandated for substances with abuse potential (e.g., opioids).
      • Dangerous Goods (ADR): If the pharmaceutical has hazardous properties (flammability, toxicity), it falls under ADR rules dictating packaging, labeling, and vehicle placarding.

      By adhering to these regulations, all stakeholders involved in the pharmaceutical supply chain contribute to the safe and effective delivery of these critical products, ultimately protecting public health.

      What is pharmalogistics?

      Pharmalogistics is the specialized management of the complex processes involved in the pharmaceutical supply chain. This includes the transportation, storage, and distribution of pharmaceutical products, from the manufacturer to the end consumer (patients). Pharmalogistics is a critical component of the healthcare industry, as it ensures that medications are delivered safely, efficiently, and on time to those who need them. Due to the sensitive nature of pharmaceutical products, pharmalogistics often requires strict adherence to temperature controls, regulatory compliance, and security measures to maintain product integrity and patient safety.

      Cold Chain Management for Pharmaceuticals & Biologics

      Maintaining the integrity of temperature-sensitive pharmaceuticals and biologics throughout the supply chain is paramount to their efficacy and safety. Cold chain management requires meticulous attention to detail, robust technology, and comprehensive training to prevent costly product degradation and ensure patient well-being.

      Risk Management & Quality Assurance in Life Sciences Logistics

      Mitigating risk and ensuring quality are non-negotiable in the life sciences supply chain. Robust risk management systems, rigorous quality assurance practices, and a culture of continuous improvement are essential for protecting patients, maintaining regulatory compliance, and minimizing disruptions.

      VIDEO: Inbound pharma supply chain

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      Pharmaceuticals & Air Freight

      The global demand for temperature-sensitive pharmaceuticals has risen sharply, making air freight essential for safe and efficient delivery.

      Airlines strictly adhere to temperature control regulations, ensuring the efficacy of these vital medicines upon arrival. Pharmaceuticals constitute a major portion of temperature-controlled air cargo, ranging from vaccines to complex medical devices. While more expensive, air freight is crucial for time-sensitive shipments like clinical trials or radioactive medicines, where delays could compromise patient care.

      The airfreight journey of pharmaceutical cargo involves several key checkpoints:

      1. Manufacturers & Shippers: Proper packaging and pre-conditioning of products to maintain temperature integrity during transit.
      2. Ground Transportation (Origin): Temperature-controlled trucks transport products to the origin airport, ensuring the cold chain is maintained.
      3. Origin Airport Ground Handlers: Specialized ground handlers manage the transfer and storage of cargo in climate-controlled warehouses, preventing temperature excursions.
      4. Tarmac/Apron Areas: Rapid transfer of cargo to and from the aircraft minimizes exposure to extreme temperatures on the tarmac.
      5. Aircraft Cargo Hold: Stringent temperature and humidity controls within the aircraft ensure product stability throughout the flight.
      6. Airport Ground Handlers (Destination): Ground handlers at the destination airport maintain the cold chain during unloading and transfer to temperature-controlled vehicles.
      7. Ground Transportation (Destination): Temperature-controlled trucks deliver products to distributors or consignees, maintaining the cold chain until the final destination.
      8. Customs or Regulatory Hold: Efficient clearance processes prevent delays that could compromise temperature-sensitive products.
      9. Warehousing: Specialized warehouses with strict temperature and humidity controls provide safe storage for pharmaceutical products when immediate delivery is not possible.
      10. Distributors & Consignees: Final inspection of products upon receipt to verify integrity and adherence to temperature requirements.

      Source: IATA

      EU rules: Good Distribution Practice

      Good Distribution Practice for medicines for human use is set out in guideline 2013/C 343/01 of 5 November 2013. It binds every party that stores, transports or supplies medicines, from the wholesaler to the driver, and it covers quality management, personnel, premises and equipment, documentation, operations, complaints and returns, outsourced activities, self inspection and transport.

      The requirements come down to control and proof. Storage areas and vehicles have to hold the temperature range the product needs, with calibrated monitoring and an alarm on deviation. Every movement is documented so that a batch can be traced to its source and to its destination. Deviations, complaints, returns and suspected falsified products are recorded and investigated, and each site inspects itself against an approved schedule.

      There is no GDP certificate a company can simply buy. National inspectorates issue them after inspection. In the Netherlands the Health and Youth Care Inspectorate inspects every new applicant for a wholesale licence and carries out risk based inspections at existing licence holders, and both the licence and the GDP certificate follow from that inspection.

      growth pharma market eu

      Licences for storing medicines in the Netherlands

      Good Distribution Practice says how medicines must be handled. Dutch law says who is allowed to hold them, and that decides which providers can take your stock at all.

      A party that obtains medicines within the EEA and supplies them onward needs a wholesale distribution authorisation, in Dutch the groothandelsvergunning. Farmatec issues it on behalf of the Ministry of Health, Welfare and Sport, on the advice of the Health and Youth Care Inspectorate. The application costs 1,700 euro and the licence costs 1,600 euro per year. The decision period is 90 days, or 30 days for a change that only concerns the qualified persons named on the licence, and the licence runs for an indefinite period. Licences and GDP certificates are issued from the organisation record in the European Organisation Management Service, so that record has to be correct before an application is filed.

      When a warehouse needs its own licence

      For a third party warehouse the test is time in storage. Under the inspectorate's GDP guidance, a provider that keeps medicines at one location for less than 72 hours, which is what a hub or a cross dock does, does not need a groothandelsvergunning in the Netherlands. From 72 hours the site needs its own licence and the provider is registered as a contract wholesaler, in Dutch the loongroothandelaar. GDP applies in both situations. The party that owns the goods signs a written contract that sets out the GDP tasks and responsibilities on each side and remains responsible for the result, so auditing the site is part of selecting the provider.

      Three questions settle whether a Dutch provider can quote for pharmaceutical stock at all: whether it holds a groothandelsvergunning, which address that licence covers, and whether it can act as your contract wholesaler. A provider without a licence can still carry the goods and hold them briefly in transit.

      Opium Act substances

      Products under the Opium Act need a second permission. Storage and transport of Opium Act substances require an opiumontheffing, also issued by Farmatec on the advice of the inspectorate. It costs 1,000 euro per application, granted for at most five years at a time, plus 700 euro per year, and the decision period is three months. Requests that concern cannabis go through the Bureau voor Medicinale Cannabis instead. The exemption is tied to the party and the site, so it has to be confirmed for the specific warehouse.

      Medical devices

      Medical devices sit outside the medicines licence regime. A party that stores devices and supplies them onward is a distributor under Regulation (EU) 2017/745. Article 14(3) requires the distributor to ensure that storage and transport conditions comply with the conditions set by the manufacturer while the device is under its responsibility. Article 14(2) requires it to verify the CE marking, the EU declaration of conformity, the information supplied by the manufacturer and, where applicable, the UDI before making a device available. In practice the manufacturer's storage instructions belong in the rate card and in the temperature records of the site.

      Rates and service scope for a Dutch contract are covered in warehousing in the Netherlands and in comparing 3PL quotes in the Netherlands, and temperature controlled storage is covered in cold chain logistics.

      Logistics Companies Specialized in Healthcare and Pharma

      Some of the largest players in the pharmalogistics industry include:

      DHL Global Forwarding: A leading provider of air, sea, and road freight services for pharmaceuticals, offering specialized solutions for temperature-controlled transportation and supply chain management.

      Kuehne + Nagel: A global logistics company with extensive experience in pharma and healthcare logistics, providing end-to-end solutions including warehousing, distribution, and value-added services.

      UPS Healthcare: A division of UPS specializing in healthcare logistics, offering global transportation, storage, and distribution solutions for pharmaceuticals, medical devices, and other healthcare products.

      DB Schenker: A global logistics provider with a dedicated healthcare division offering customized solutions for the pharmaceutical industry, including temperature-controlled transportation and supply chain visibility.

      FedEx Express: A leading provider of express transportation services, offering specialized solutions for the transportation of time- and temperature-sensitive pharmaceuticals.

      Pharma and healthcare logistics providers in the Netherlands

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