The healthcare and pharmaceutical sector covers all fields which provide goods and services for the treatment of patients. This includes the manufacture, transport and distribution of products that serve to maintain or restore health.
Due to the fact these products are subject to very different requirements for transport and storage, it is helpful to break down the industry into pharmaceutical and non-pharmaceutical goods to begin with.
Pharmaceutical goods
Pharmaceutical logistics can be further subdivided into:
- logistics for clinical trials
- logistics for generics and over-the-counter (OTC) medicines
GDP (Good Distribution Practice) plays a key role for pharmaceutical products. GDP sets out the good distribution practices designed to ensure that medicines retain their quality and efficacy throughout the entire transport and storage process.
The GDP rules stipulate:
- that medicines must be transported and stored under controlled temperature conditions,
- that supply routes and batches must be fully traceable,
- that appropriate means of transport, storage facilities and packaging must be used,
- and that staff must receive regular training to meet the high safety and quality standards.
GDP is legally required and is inspected by national and European authorities. Companies that store or transport medicines must be in possession of valid GDP certification.
Focusing on temperature control
The current political debate in Germany is primarily concerned with how strictly temperature control should be regulated for the shipment of medicines. The Federal Ministry of Health (BMG) plans that, in future, suitable carriers must be appointed for temperature-sensitive medicines who can provide uninterrupted temperature records and retain those records for three years. At the same time, there is increasing pressure for controls and spot checks across the supply chain — particularly for overseas shippers or in extreme weather conditions (e.g. heat waves, severe frost).
In operative terms this means:
- In the case of products that require refrigeration, strict documentation, validated packaging and specialist carriers are advisable.
- In the case of ambient-temperature products, preventive measures (e.g. good packaging, active temperature control and monitoring) are important.
- Those who invest in the supply chain now — especially in specialist service providers — will secure competitive advantages: lower risks during audits, fewer complaints, and better security of supply.
Non-pharmaceutical goods
Non-pharmaceutical products such as medical devices, consumables (e.g. wound dressings) or diagnostic equipment are also subject to specific requirements. The logistical demands vary greatly depending on the product — storing and delivering single-use items such as plasters is significantly simpler than transporting and servicing an MRI scanner.
Different standards usually apply here, for example ISO 13485 for quality management in medical technology, and CE marking for product safety within the EU.
HS codes and legal classification
According to the World Customs Organisation’s international goods classification (HS codes), the following apply:
- Pharmaceutical products fall under HS code 30: “Pharmaceutical products”.
- Medical devices and instruments fall under HS code 90: “Optical, photographic, measuring, checking, medical or surgical instruments and apparatus; parts and accessories thereof”.
- In some definitions the chemical sector is extended to include the pharmaceutical industry; however, in the chemical sector profile this is only the case when it is explicitly stated.
Why work with a specialist logistics provider?
In a nutshell: to secure quality, simplify compliance, reduce liability risks, and to do so in a measurable way.
- Specialist logistics providers operate fully in accordance with GDP: valid certificates, validated processes (e.g. packaging, pre-conditioning, lane qualification) and automated temperature documentation.
- They provide verifiable evidence — e.g. temperature data and long-term archiving — and make audits easier.
- They have preventive measures in place for risk scenarios (heatwaves/frost) and specially trained teams with appropriate vehicles.
- This reduces failures, damage and recalls — particularly for sensitive medicines that require refrigeration.
- Special sorting systems with gentle transfer chutes and dedicated security technologies are often used.
- Appropriate cold-storage facilities with emergency power generators and security measures to prevent unauthorised access ensure optimal storage conditions.
- Reusable packaging is tailored to recipients’ needs and reduces packaging waste.
- Those who opt for specialist logistics providers today will be better placed for future regulatory requirements — and can demonstrate to customers, auditors and authorities that they have a secure command over their supply chain.
