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...

  • ACE Import Requirements Updates

    As CBP and the other government agencies get closer to the full implementation of the single-window environment known as the ACE, U.S. importers must have a strong process for validating import documents and making sure complete and accurate information is submitted through ACE upon making entry of imported goods. While the use of ACE is… Read more »

  • FDA Guidance on Identifying Suspect Products in the Drug Supply Chain

    The FDA recently published the final guidance[i] on the identification of suspect product and notification. The guidance is intended to aid pharmaceutical trading partners (manufacturers, re-packagers, wholesale distributors, and dispensers) in identifying a suspect product and notifying FDA and other partners in the supply chain. Since the implementation of the Drug Supply Chain Security Act… Read more »

  • Trade requirements for unused biological sample collection kits containing IVDs

    The term IVD covers a diverse range of products from individual reagents to specimen receptacles to entire medical testing systems. IVDs are defined as medical devices which can be a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, intended for in-vitro examination of specimens, derived from the human body.[i]  Because IVDs… Read more »

  • Argentina: New Import Declaration form for Clinical Supplies

    In an effort to streamline importations of clinical supplies, Argentina’s Ministry of Health, Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) announced the creation of a new import declaration form.[i] The new, so called 12-point declaration form, will replace the current 15-point form which is used for most imports into Argentina. The new 12-point… Read more »

  • Import Tariff Rate Reductions in Russia

    In a continued effort to align with World Trade Organization (WTO) rules for trade facilitation[i], The Federal Customs Service of Russia has reduced tariff rates for more than 1700 Harmonized Schedule (HS) codes. The reduced rates went into effect on September 1, 2016, and impact many different industry sectors. Examples of reduced tariff rates that… Read more »

  • Products Containing Lactose and Lactose Derivatives‏ Will Not Require a USDA Import Permit

    On September 12, 2016, The United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service’s (APHIS) Veterinary Services (VS) announced that products containing lactose, galactose or lactulose as the ONLY animal origin ingredient may enter into United States without a USDA APHIS VS import permit. The decision to remove import permit requirements for… Read more »

  • India’s Import/Export License Requirements for Human Biological Samples Removed

    Laboratories and clinical investigational sites in India will find it easier to import and export shipments of human biologic samples now that import/export license requirements have been lifted.   In a notice issued on August 4th, India’s Directorate General of Foreign Trade (DGFT)[i] announced it would no longer require import or export licenses for human biological… Read more »

  • New ACE FDA Intended Use Codes Result in Different Reporting Responsibilities for Customs Brokers and Importers

    Now that the US Customs Automated Commercial Environment (ACE) is in full use, Customs brokers have new reporting responsibilities. While ACE does not create new import requirements for FDA-regulated products, it does require brokers to provide additional data elements in their import entries.  For example, brokers must now report an FDA intended use code for… Read more »

  • Mexico’s CFDI Export Reporting Requirement Revised

    The Mexican Treasury Department (SAT) has revised the new CFDI export reporting requirement to exclude non-commercial shipments.  According to a resolution[i] published on June 22nd, Article 3.1.35 of the 2016 General Foreign Trade Rules is amended to apply exclusively to commercial transactions as defined by Article 14 of the Foreign Trade Rules. As a result… Read more »

  • Mexico’s New Export Requirement Postponed

    As the July 1st deadline for complying with Mexico’s new CFDI export reporting requirement quickly approaches, exporters and their agents are concerned with how the reporting will be implemented. However, there soon may be good news for exporters. According to the Mexican Customs broker association CAAAREM, SAT is expected to announce that the CFDI reporting… Read more »

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