What legal risks do exclusive pharmaceutical export agents need to bear? How to choose compliant partners?

What core responsibilities do exclusive pharmaceutical export agents actually bear?

Exclusive Export Agent in pharmaceutical exports, asthe legally recognized primary responsible party, must undertake the following core obligations:

• Product registration and filing: Responsible for preparing and submitting drug registration documents for target markets
• Quality system maintenance: Ensure compliance with importing countrys GMP certification requirements (such as EU EudraGMDP database filing)
• End-to-end logistics traceability: Establish a cold chain transportation monitoring system compliant with WHO standards
• Adverse reaction monitoring: Implement Pharmacovigilance system management

What are the legal differences between ordinary distributors and exclusive agents?

According to theInternational Convention on Allocation of Liability in Pharmaceutical Tradeeffective in 2025, their legal differences are mainly reflected in:

• Responsible entity:
  • Exclusive agents directly bear product liability
  • Distributors only bear contractual breach liability
• Regulatory obligations:
  • Exclusive agents must establish quality traceability systems
  • Distributors only need to verify product legality

What new regulatory challenges will pharmaceutical exports face in 2025?

Global pharmaceutical regulation shows three major trends:

• Mandatory electronic traceability: 94 countries require UDIMedical EquipmentUnique Device Identification
• Stricter data compliance: EU MDR new regulations require 10-year clinical data retention
• Upgraded environmental standards: WHO adds new drug packaging recyclability indicators (effective July 2025)

Typical case: A Chinese API manufacturer failed to complete Brazil ANVISAs GLP certification, resulting in the exclusive agent being fined 200% of the cargo value.

How to evaluate potential partners compliance capabilities?

Recommend establishing an evaluation matrix from three dimensions:

• Qualification verification:
  • Check registration status with FDA/EMA and other regulatory agencies
  • Verify ISO 13485 Medical Device Quality Management Certification
• Risk prevention:
  • Request audit reports from the past 3 years
  • Validate GDP certification qualifications of logistics partners

What key clauses must be included in exclusive agent contracts?

According to the 2023 EU Court ruling (Case C-621/22), it is recommended to focus on:

• Liability allocation clauses: Clearly define responsibility mechanisms for product defects
• Data sovereignty clauses: Specify ownership and usage rights of clinical trial data
• Emergency handling clauses: Establish specific product recall processes and cost-sharing mechanisms

Special note: 2025 legislation in multiple countries requires contracts to includeArtificial Intelligence Review Terms, used for monitoring supply chain anomalies.