A Physical Site of Importation (SOI) in the pharmaceutical industry plays a crucial role in handling customs clearance for pharmaceutical products. Customs clearance involves complying with customs regulations and procedures to facilitate the lawful entry of imported pharmaceuticals into a country. Here’s how a SOI typically handles customs clearance:

  1. Documentation Preparation:
    • Gather all required documentation for customs clearance, including import permits, licenses, commercial invoices, packing lists, certificates of analysis, certificates of origin, and any other relevant paperwork. Ensure that all documents are accurate and complete.
  2. Product Classification:
    • Properly classify the pharmaceutical products using the appropriate Harmonised System (HS) or customs tariff codes. Accurate product classification is essential for determining applicable import duties, taxes, and regulatory requirements.
  3. Customs Declaration:
    • Prepare and submit a customs declaration (customs entry) to the relevant customs authorities. The declaration provides detailed information about the imported pharmaceutical products, such as product descriptions, quantities, values, and origin.
  4. Payment of Duties and Taxes:
    • Calculate and pay any applicable import duties, taxes, customs fees, and other charges required by the importing country’s customs regulations. This includes customs duties, value-added tax (VAT), excise taxes, and other levies.
  5. Compliance with Regulatory Requirements:
    • Ensure that the imported pharmaceutical products comply with all relevant regulatory requirements in the importing country. This includes adherence to quality standards, labeling and packaging regulations, and any specific pharmaceutical import regulations.
  6. Customs Brokerage:
    • Many pharmaceutical companies utilize customs brokers or customs clearance agents with expertise in customs procedures. Customs brokers assist in preparing and submitting customs documentation, ensuring compliance, and facilitating communication with customs authorities.
  7. Inspection and Examination:
    • Be prepared for customs authorities to conduct inspections or examinations of the pharmaceutical products. Cooperate fully with these inspections and provide any requested information or samples.
  8. Security Measures:
    • Implement security measures to safeguard pharmaceutical products from counterfeiting, tampering, or diversion during the customs clearance process. Serialisation, track-and-trace systems, and other security measures may be employed to verify product authenticity.
  9. Post-Clearance Procedures:
    • Complete any additional post-clearance procedures that may be required by customs authorities or regulatory agencies to release the pharmaceutical products into the local market. This may include obtaining release orders or permits.
  10. Record Keeping:
    • Maintain comprehensive records of all customs clearance activities, including customs declarations, invoices, receipts, and correspondence with customs authorities. These records are crucial for audit purposes and regulatory compliance.
  11. Communication with Regulatory Authorities:
    • Maintain open and transparent communication with regulatory authorities, such as the pharmaceutical regulatory agency in the importing country. Address any issues or inquiries related to customs clearance and regulatory compliance promptly.
  12. Continuous Compliance Monitoring:
    • Stay informed about changes in customs regulations and import requirements to ensure ongoing compliance. Regularly monitor updates or modifications that may affect the customs clearance process for pharmaceuticals.

Effective customs clearance is essential to maintain a smooth and compliant supply chain for pharmaceutical products. The SOI must manage this process meticulously to prevent delays, regulatory issues, or supply disruptions.


For any questions get in touch with us at info@miaspharma.com