Regulatory Updates

The Latest

Australia: Imports of Placebos and Clinical Trial Kits Now Duty Free

As of July 1, 2018, imports into Australia of clinical trial kits containing placebos or a combination of medicines and placebos are duty-free. A recent update to the Australian Customs Tariff[i] introduced new “Free” rate of duty provisions for clinical trial kits and...

  • Sarajevo International Airport Rescinds Temporary Import Ban

    Sarajevo International Airport (SJJ) removed their temporary ban on imports of medicines and medical devices, on June 9. After meeting with local aviation authority representatives, the Agency for Medicinal Products and Medical Devices Bosnia and Herzegovina (ALMBIH) and Customs officials, SJJ decided to allow the import of health products as long as importers and their… Read more »

  • Sarajevo International Airport Temporarily Bans Imports of Medicines and Medical Devices

    On May 23, 2016, Sarajevo International Airport (SJJ) issued a temporary ban on all imports of medicines and medical devices. Until further notice, shipments arriving into SJJ will be immediately returned to their port of origin. This temporary ban is the result of an ongoing dispute between SJJ and the Agency for Medicinal Products and… Read more »

  • Mexico’s New Export Requirement

    Regulatory changes in Mexico will result in additional requirements for exporters.  Mexican companies are required to report their taxable, commercial trade transactions to the Treasury Department (SAT) by submitting an electronic certified commercial invoice: a process known as CFDI fiscal reporting. According to Article 3.1.25[i] of the new, 2016 General Foreign Trade Rules, exporters must… Read more »

  • Import of Medicines and Devices to Singapore Simplified

    Importers and declaring agents in Singapore will soon have access to a simplified import process for shipments health products. Singapore’s Health Sciences Agency (HSA) announced several administrative and procedural changes which the agency plans to reduce the number of import documents and simplify the entry process for healthcare products. As of May 3, 2016, the… Read more »

  • New Import Requirements for Placebos used in Australian Clinical Trials

    As of June 1, 2016, companies importing clinical-use placebos into Australia will need to provide information about the placebo’s producer. Currently, Australian food importers are required to provide producer information only for certain, so-called, risk foods. However, a recent announcement by the Australian Department of Agriculture and Water Resources confirmed that importers will need to… Read more »

  • Clinical Trials in Latin America Get a Boost from Improved Regulatory Compliance Processes

      With its large and diverse population, Latin America continues to be an important region for clinical trials. However, despite the benefits of a large treatment naïve population, complex regulatory frameworks and lengthy approval times present a unique set of regional challenges when setting up new clinical studies.  A group of countries in Latin America… Read more »

  • CSafe Shares Enhanced Qualified Users Program (EQUiP) Training with Marken on AcuTemp Active RKN Container

    Marken maintains the integrity of every product by critically analyzing and carefully handling each step of the cold chain shipping process. The successful distribution of temperature-sensitive cargo requires both management and operators to fully understand unique relationships and requirements of shippers, freight forwarders, integrators, partners, and airlines. Cold chain experts at Marken have recently received… Read more »

  • Customs Modernization Initiatives

      In recent years, the Customs agencies worldwide have actively engaged in what is often referred to as Customs modernization initiatives. The goal of these projects is to bring Customs and it procedures into the 21st century and equip the agencies to better face the challenges of a global economy where e-commerce and highly complex… Read more »

  • Customs ACE Transition Frequently Asked Questions

    As Customs and the other government agencies get closer to the full implementation of the single-window environment known as ACE, U.S. importers have questions on how this will impact their import shipments. This guidance provides answers to some of the more frequently asked questions regarding the U.S. ACE Transition. What is the ACE? The Automated… Read more »

  • US Import of Chinese Hamster Ovarian (CHO) Cells, Cell Cultures, Cell lines or Derived products

    US Fish and Wildlife Service (FWS) regulates the import of all wildlife and wildlife products and requires that importers of these products be licensed and declare their shipments to the agency in order to obtain an import release.  Chinese Hamsters are considered by FWS to be regulated wildlife so shipments of actual CHO cells, cultures… Read more »

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