Regulatory Updates

The Latest

India: New Mandatory Document Requirements

 merchandise for import into the country. On Jan 14th, 2021, India’s Central Board of Indirect Taxes and Customs published Advisory No: 02/2021 announcing a new rule requiring Customs brokers to submit certain documents to Customs when clearing merchandise for import int...

  • India: New Mandatory Document Requirements

     merchandise for import into the country. On Jan 14th, 2021, India’s Central Board of Indirect Taxes and Customs published Advisory No: 02/2021 announcing a new rule requiring Customs brokers to submit certain documents to Customs when clearing merchandise for import into the country. The new rule requires mandatory uploading of product-specific documents in the e-Sanchit… Read more »

  • New EU Mandatory Export Authorization for COVID 19 Vaccines

    The European Commission announced last week a new, mandatory export authorization requirement for COVID-19 vaccines covered by an Advance Purchase Agreement (APA) with the EU. The new rule applies to vaccines against SARS-related coronaviruses (SARS-CoV species) falling under CN code 3002 20 10 and cover active substances including master and working cell banks used for… Read more »

  • US: Importing COVID-19 Diagnostic Test Kits

    AUTHOR: Reynaldo Roman | Senior Director, Regulatory Compliance COVID-19 diagnostic test kits and other in vitro diagnostic devices (IVDs) are FDA-regulated products that require FDA and Customs and Border Protection (CBP) clearance when imported into the US. The FDA regulates imported medical devices and IVDs. Generally, imported devices must have FDA marketing approval or must… Read more »

  • US: New Export Filing Requirement for Shipments to China, Russia or Venezuela

    AUTHOR: Reynaldo Roman | Senior Director, Regulatory Compliance As of June 29, 2020, exporters of shipments to China, Russia, or Venezuela must comply with a new, mandatory export filing requirement. Any export shipment from the United States to China, Russia, or Venezuela, involving an item classified under an Export Control Classification Number (ECCN), requires an… Read more »

  • AVOID CLINICAL TRIAL DISRUPTION IN SOUTH AFRICA

    MARKEN UTILIZES GLOBAL NETWORK TO REACH PATIENTS THROUGHOUT THE WORLD During this critical time, while countries like South Africa are extremely limited with transport options, Marken utilizes our global network to safely transport biological sample shipments out of the country and ship clinical drug products to sites and patients. Our fully operational status ensures we… Read more »

  • US Importation of PPE

    AUTHOR: Reynaldo Roman | Director, Regulatory Compliance In an effort to facilitate the import and supply of PPE into the US, both Customs (CBP) and the FDA have provided guidance on the types of PPE that may be imported. To combat PPE shortages, the FDA has invoked its Emergency Use Authorization (EUA) authority to lift… Read more »

  • Coronavirus COVID-19 and Dangerous Goods handling / Transportation F.A.Q.

    AUTHOR: Nora Pasinetti Sauter In the light of the rapidly evolving situation of COVID 19 epidemic and recent reports from the WHO (World Health Organization), US CDC (Center for Diseases Control & Prevention), ECDC (European Center for Diseases Prevention & Control), Marken has developed the following FAQ.   What is the Dangerous Goods Classification for… Read more »

  • China: CFDA New Drug Import License Procedure

    AUTHOR: Reynaldo Roman China Food and Drug Administration’s new import licensing procedure requires importers to apply for their CFDA import license online. In an ongoing effort to modernize trade, China Food and Drug Administration (CFDA) announced that as of December 27, 2019, importers must apply for their drug import licenses via the China International Trade… Read more »

  • U.S. Federal Government Shutdown

    In the wake of the U.S. federal government shutdown, life science companies question how it may affect their critical shipments of clinical supplies and biological lab samples. Currently, Marken is not experiencing any significant delays in processing import or export entries at U.S. ports. Besides customs, our primary concern relates to the services provided by… Read more »

  • 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 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 »

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