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Dedicated logistics team speeds up importation process
Despite the substantial progress being made toward global regulatory alignment in Latin America, customs requirements continue to evolve and often differ significantly amongst even neighboring countries. Early planning is essential when importing supplies into Latin America. Our client, one of the top 10 leading multinational pharmaceutical companies, was conducting multiple Phase II/ III trials in Latin America with particular emphasis on Brazil. Whilst the Sponsor had partnered with Fisher Clinical Services to fully manage its transportation strategy, there was one element of the overall supply chain strategy that had been kept in-house. For historical reasons, the Sponsor continued to use its local office in Brazil to act as Importer Of Record (IOR).

The role of Importer Of Record
The Importer Of Record is a legal entity responsible for:

  • Ensuring the imported goods comply with local laws 
  • Filing a completed duty entry & associated documents 
  • Paying the assessed import duties & other taxes on those goods

The Sponsor was experiencing continued delays to the importation of supplies which was impacting on deliveries to patients at investigator sites. Factors contributing to these delays included:

  • Many hand-offs across the supply chain between different entities 
  • Uncertainty of roles & responsibilities of all parties to the supply chain 
  • Lack of visibility of supplies 
  • Slow processing of supplies through customs

Fisher Clinical Services to handle importation
With a track record of excellence in importing clinical supplies into Brazil since establishing a dedicated import/export team in 2012, the Sponsor made the decision to appoint Fisher Clinical Services to handle the importation processes into Brazil.

The client recognized that Fisher Clinical Services Brazil successfully facilitated the importation process for investigational drugs, placebos, biological drugs, controlled drugs, comparator drugs and ancillaries.

Regulations RDC 39/2008 & 09/2015
Today clinical trials can be submitted to the Brazilian MOH ANVISA through different regulations:

  • RDC 39/2008 – import license needs to be authorized PRIOR to shipping supplies to Brazil 
  • RDC 09/2015 – import license is required AFTER approval at the Brazilian airport 

With oversight of all Brazilian shipments from end-to-end, the Fisher Clinical Services Logistics Team was able to manage the customs process as well as preparing the ‘Nota Fiscal’ to release all shipments faster than the Sponsor’s local office. Significant time savings were achieved due to proficient documentation review and faster payment of taxes & duties. Customs clearance was streamlined via an established network of broker contacts fully versed on the importance of maintaining integrity of supplies for Fisher Clinical Services’ shipments.

Benefits to the Sponsor

  • Improved process efficiency 
  • Reduced number of handoffs giving lower risk of miscommunication or document handover 
  • End-to-end visibility of supplies allowing intervention where necessary 
  • Secure chain of custody, control & compliance 
  • Continued reduction in lead-time by a total of 11 days 
  • Improved investigator site satisfaction because of fewer delays 
  • Faster delivery of clinical supplies to patients

Global Reach & Compliance
Leveraging its global network of strategically located cGMP facilities, logistics expertise and in-country experts, Fisher Clinical Services is in the unique position to handle the entire supply chain from start-to-finish, including the provision of Importer Of Record services in 24+ countries. Sponsors are assured that Fisher Clinical Services is fully vetted and compliant with regional and country-specific laws related to the provision of Importer Of Record services.

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