For Sri Lankan pharmaceutical businesses, exporting medicine requires more than just getting products out the door — it demands precision, compliance, and secure logistics. The pharmaceutical supply chain is one of the most highly regulated sectors in the world, and failing to adhere to these regulations can result in costly delays or even shipment rejections.
DHL Express is your trusted partner in navigating complex international requirements, whether you're learning how to export medicine or scaling your operations. DHL Express's dedicated services ensure that shipping medicine internationally is faster, safer, and fully compliant.
Step 1: Understanding import and export regulations for medicines
Before shipping medicine overseas, it’s essential to understand both Sri Lanka’s export regulations and the import rules of the destination country. In Sri Lanka, pharmaceutical exporters must comply with guidelines set by the National Medicines Regulatory Authority (NMRA). Meanwhile, import regulations are governed by authorities such as:
- Health Sciences Authority (HSA) – Singapore
- Food and Drug Administration (FDA) – United States
- Medicines and Healthcare products Regulatory Agency (MHRA) – United Kingdom
- China Food and Drug Administration (CFDA) – China
For controlled substances, it's important to consult official lists like the Health Sciences Authority (HSA)’s list of controlled drugs to ensure compliance when sending medication abroad.
Obtaining necessary export licenses and permits
To legally export pharmaceutical products from Sri Lanka, you must obtain export licenses and permits through the following steps:
- Register with NMRA.
- Fill out the official NMRA export license form, providing product details, destination information, and consignee data.
- Submit documentation:
- Certificate of Pharmaceutical Product (COPP)
- Certificate of Analysis (COA)
- Batch Release Certificate
- Product Registration Certificate (if applicable)
- Packing List and Commercial Invoice
- Import permit from the destination country (if required)
- NMRA may also conduct document reviews or facility inspections before granting final approval.
Complying with the destination country's import regulations
Every country classifies and regulates medicine differently. A supplement sold as Over-the-Counter (OTC) in Sri Lanka might be classified as a prescription drug elsewhere. Knowing how to ship medication internationally depends on understanding these distinctions:
| Medicine Type | Common Import Requirements |
|---|---|
| Prescription Medicines | Import permit, product registration, doctor’s prescription, batch details, and certificates (e.g., Certificate of Analysis) |
| OTC | May require approval based on ingredients or dosage; compliant packaging and labeling; some products reclassified as prescription-only |
| Controlled Substances | Strictest regulations; special import permits, pre-approval from authorities, justification for use, and secure handling protocols |
Step 2: Ensuring product integrity and packaging compliance
Beyond regulatory requirements, maintaining the integrity of pharmaceutical shipments is vital. Proper packaging — especially when shipping medication — is key to preserving product quality and meeting compliance standards.
Packaging for temperature-sensitive medicines
DHL Express supports exporters with end-to-end cold chain logistics and Good Distribution Practice (GDP)-compliant handling procedures designed for pharmaceutical-grade products. These services include:
- Validated temperature-controlled packaging to maintain consistent conditions
- Active and passive cooling systems to match your specific shipping needs
- Real-time temperature and humidity monitoring for full shipment visibility
Labeling requirements and documentation
Labels should typically include:
- Active ingredients and concentrations
- Expiration date
- Batch/lot number
- Storage conditions (e.g., “Keep refrigerated” or “Store below 25°C”)
- Manufacturer’s name and contact details
In addition to proper labeling, each shipment must be accompanied by comprehensive documentation, which may include:
- Certificate of Analysis (CoA)
- Certificate of Origin
- Manufacturing license
- Export permit and import license
- Commercial invoice and packing list
Together, proper labeling and complete documentation support product authenticity, traceability, and compliance.
Step 3: Selecting the right DHL Express service for pharmaceutical shipments
DHL Medical Express (WMX) for time-sensitive and temperature-controlled shipments
WMX shipments receive priority handling to meet the urgent demands of time-sensitive pharmaceutical deliveries. With extended collection cut-offs and expedited transit, we ensure your medicines reach their destination as quickly and reliably as possible. Choose from a full range of temperature-control options—including ambient, controlled-ambient (15°C to 25°C), refrigerated (2°C to 8°C), frozen with dry ice (-80°C), frozen (-15°C to -25°C), and ultra-deep frozen (below -180°C).
We also provide contingency services such as dry ice replenishment and access to refrigerated facilities when needed. With DHL Medical Express services, you can trust that your temperature-sensitive pharmaceuticals are handled with the highest level of care, compliance, and efficiency.
Choosing the appropriate packaging and service based on the medicine type
Selecting the right combination of packaging and DHL service is essential to meet the DHL Express requirements for international shipping of medicine. Doing so ensures regulatory compliance and preserves product quality during transit.
| Medicine Type | Recommended Packaging | Best DHL Service |
|---|---|---|
| Biologics and Vaccines | Cold chain with data logger | DHL Medical Express (WMX) |
| OTC Medications | Pharma-grade insulated box | DHL Express |
| Prescription Medicines | Tamper-evident and labeled box | WMX |
Step 4: Customs clearance and delivery with expert support
After your shipment leaves Sri Lanka, the next step is clearing customs in the destination country. This process involves reviewing documentation and calculating duties and taxes based on local laws.
Understanding duties, taxes, and import permits
Duties are typically tariffs imposed on imported goods, often calculated as a percentage of the declared value. Taxes, such as Value Added Tax (VAT) or Goods and Services Tax (GST), may also be applicable. The specific rates and calculation methods vary significantly from country to country and can even depend on the type of medicine being imported.
While DHL Express cannot obtain import permits on your behalf, we can help guide you through the process, offering insights into required documentation and pointing you toward relevant local authorities. We can also provide estimates of duties and taxes, helping you plan costs more accurately.
Real-time tracking and monitoring for peace of mind
Once your shipment clears customs, real-time tracking ensures full transparency from dispatch to delivery. DHL Express provides advanced tracking tools accessible via web or mobile, so you can monitor location and delivery status at any time.
For temperature-sensitive shipments, our systems offer additional tracking of temperature and humidity, ensuring that your medicines remain within required conditions throughout the journey. This visibility brings confidence, knowing your shipment is on track and intact.
Your reliable partner for medicine imports and exports – DHL Express
Can I send medicine by DHL Express? Absolutely. DHL Express is the trusted logistics partner for Sri Lankan pharmaceutical businesses looking to deliver overseas with speed, compliance, and care. With deep expertise in international medicine shipping, we manage everything from temperature-controlled logistics to documentation and customs support, so you can focus on growing your business with confidence.
Ready to expand your pharmaceutical imports and exports? DHL Express has you covered. Open a DHL Express business account today and take the first step toward secure, seamless global deliveries.
