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...

  • 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 placebos under Schedule 4, item 56. The kits and placebos covered under the new… Read more »

  • US: Proposed Tariff Rate to Impact Clinical Supplies Imported from China

    The Office of the U.S. Trade Representative (USTR) published a list of products that are subject to the proposed tariff increase on goods imported from China[i]. The targeted tariff will impose an additional 25% tariff rate on approximately 1,300 products from China Included in the list of products affected by the 25% tariff increase are… Read more »

  • Australia: Updated Clinical Trial Handbook

    On March 15, Australia’s Therapeutic Goods Administration (TGA) published a revised version of their Clinical Trial Handbook[i]. The updated handbook provides guidance on the legal framework for conducting clinical trials of unapproved therapeutic products in Australia. While the handbook does not describe all of the requirements for conducting clinical trials, it is a valuable resource… Read more »

  • Argentina: Procedural Changes to the 9-point Form Submission

    As of February 1, 2018, Argentina’s Ministry of Health (ANMAT) is only accepting the 9-point inspection information required for the export of biologic specimens via the TAD electronic system. Paper versions of the 9-point inspection previously used by the agency will no longer be accepted. The 9-point inspection information is used to capture export shipment… Read more »

  • Marken Addresses Volgograd Airport Acceptance of Dangerous Goods

    Please note that the Volgograd Airport in Russia has halted the acceptance of Dangerous Goods materials effective immediately.  While this development will affect couriers who rely on this airport for transport of their DG shipments as a waypoint through Russia, Marken is NOT affected as our teams already have alternative means in place to route… Read more »

  • Brazil: Import and Export Clearance delays due to Processing of GRU/GVS

    Shipments of patient kits and biological specimens are facing Ministry of Health clearance delays caused by technical problems with the ANVISA GRU/GVS web portal. Importers and exporters in Brazil are required to process their ANVISA sanitary surveillance inspection fees (GRU/GVS) through an ANVISA web portal so that they or their agent (e.g., Marken) can pay… Read more »

  • Argentina’s New Rules for Import and Export of Biologic Specimens

    Until recently, companies in Argentina were required only to list the relevant clinical study protocol number when importing or exporting biologic specimens. Now, as of July 1, 2017, importers and exporters must obtain specific approval from Argentina’s ministry of health, ANMAT, for shipments of biologic specimens. According to ANMAT notification No. 0004[i], companies involved in… Read more »

  • Mexico’s CFDI Export Reporting Update and New Deadline

    The Mexican Treasury Department (SAT)’s most recent technical update on CFDI reporting has caused confusion among exporters of non-commercial samples.  According to SAT’s notice[i], new functionality will go into effect on March 1, 2017 that will allow for CFDI reporting of both commercial and non-commercial export shipments. This announcement comes as a surprise to Mexican… Read more »

  • 2017 Global Harmonized System Update

    Recent updates to the U.S. Harmonized Tariff Schedule (HTS) result in new HTS classifications for pharmaceutical products.  The 2017 updates to the HTS, which went into effect on January 1, 2017, revamped several chapters and headings of the HS by deleting, adding or modifying hundreds of HTS codes[i].  Significant changes were made to chapter 30… Read more »

  • Significant Changes to the 58th Edition (2017) of IATA Dangerous Goods Regulations

    The IATA Dangerous Goods Regulations (DGR) in their 58th Edition (2017) introduce revisions that are effective starting 1st Jan 2017. The following spreadsheet identifies major changes to assist the Readers. It has not resumed all the new points communicated by the IATA extended listing. This one can be reviewed in the first pages of the… Read more »

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