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      Pharma & Healthcare Logistics

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

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      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.


      • 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

      In 2013, the EU introduced strict rules to ensure medicines are stored and shipped safely. These rules apply to everyone involved in the process, from the warehouse workers to the delivery drivers. There is no official "certification" for Good Distribution Practice (GDP) compliance under the EU directive. However, everyone in the EU is bound by these rules.

      The goal is to make sure medicines are kept in perfect condition throughout their journey, from the factory to you. To do this, companies must control the temperature and humidity in storage areas and vehicles, much like you would control your refrigerator's temperature to keep food fresh.

      Additionally, technology is used to track the location and condition of medicines during transport. This tracking system works similarly to how you can track a package online. Everyone involved must also keep detailed records to prove they've followed the rules.

      growth pharma market eu

      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.

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