GCSG Barcelona PCI Boot Camp - Import/Export Boot Camp Tuesday 23 October 2018

Sep 26, 2026

Uploaded by Connor

Training slide deck for the GCSG Barcelona PCI Boot Camp, focused on import and export compliance in pharmaceutical and medical supply logistics. Covers shipment anatomy and key definitions such as Importer/Exporter of Record (IoR/EoR), customs brokers, relevant health authorities, and the Harmonized Tariff Schedule (HTS). Explains types of import licences, the application process, customs valuation calculations, Incoterms responsibilities, and typical challenges, ending with sponsor case study and guidance for moving into the US including forms, paperwork, release, and approval.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages53

Reading Time2 h 14 min

AccessFree to download

Topics to be covered

Anatomy and Definitions

Type of Import Licences

Drug supply strategy and application process

Calculating customs valuations

Importer and Exporter of Record (IoR / EoR) and challenges

Sponsor’s case study

Moving into the States

Forms and paperwork

Achieving release and approval

Import/Export Boot Camp Tuesday 23 rd October 2018 Rich Nelson – Senior Manager of Global Logistics, PCI US Gavin Morgan – Manager of Global Storage and Distribution, PCI UK Sarah Brown-Manager-Clinical Supplies Vectura Limited, UK Topics to be covered • Anatomy and Definitions • Type of Import Licences • Drug supply strategy (direct to site versus in-country depot) • Import Licence application process • Calculating customs valuations • Importer and Exporter of Record (IoR / EoR) and typical challenges • Sponsor’s case study • Moving into the States – Forms and paperwork – Achieving release and approval Anatomy of a Shipment and Definition of terms The Anatomy of a Shipment Consignor Exporter Importer Consignee Person or Party that is physically shipping the commodities This is the person or party responsible for compliance with export regulations Commonly referred to asthe IoR…this is the person or party responsible for compliance with import regulations and the payment of any fees or taxes Person or Party that physically receives the commodities Definition of Common Terms 􀂾 Importer of Record (IoR) The party responsible for import regulation compliance, accuracy of the information submitted to customs and/or other agencies and for the payment of duties and import VAT. 􀂾 Exporter of Record (EoR) The party responsible for export regulation compliance, accuracy of the information submitted to customs and/or other agencies and for the payment of duties and export VAT. Definition of Common Terms 􀂾 Customs Broker Person / party who is licensed by the local customs authority to perform customs formalities and to act as the “representative” of the importer or exporter to agencies at the border. They are responsible for preparing and submitting all documents for clearing goods through customs and other agencies, have Power of Attorney (PoA) and pay import duties and VAT on behalf of importer/exporter. 􀂾 Ministry of Health (MoH) It is the governmental ministry or agency responsible for the regulation and approval of pharmaceutical drugs, sanitary standards, regulations of the food industry and import licenses, such as FDA, SFDA, ANVISA, ANMAT, ISP, COFEPRIS, etc. Definition of Common Terms 􀂾 Harmonized Tariff Schedule or System (HTS) A sequence of numbers which are used to classify goods for customs in a global manner. The number depends on the product’s components, specific characteristics and use and the importing country. HTS determines duties and taxes that local customs apply to a specific product, while importing to assess import duties on the shipment. HTS is composed by only 6 digits globally, but some countries have extra digits for matching their local classification system. Chapter 30: Pharmaceutical Products Chapter 90: Medical or Surgical Instruments Definition of Common Terms 􀂾 The International Commercial Terms (Incoterms) A set of international rules, governed by the International Chamber of Commerce, which determine the scope of how the international shipment will be arranged from one country to another. When used for shipment and in contracts, it provides guidance to exporter / importer / transportation vendors and others about topics such as: • when the risk associated with the goods transfers, • the place of delivery of the goods, who hires and pays transport and insurance,• who is responsible for customs clearance and pays the duties, etc. • this doesn't work for property transfer purposes

FAQs

What is the purpose of the Boot Camp training?

It teaches participants how to handle import and export compliance for pharmaceutical and medical supplies, including licences, customs valuation, responsibilities, and the documentation needed for US entry.

What do IoR and EoR mean in import/export compliance?

The Importer of Record (IoR) is responsible for import regulation compliance, accuracy of customs information, and payment of duties and import VAT. The Exporter of Record (EoR) is responsible for export regulation compliance, accuracy of information, and payment of duties and export VAT.

How does HTS affect duties and taxes?

HTS classifies goods using a global sequence of numbers based on the product’s components, characteristics, and the importing country. It determines the duties and taxes applied by local customs for a specific product and shipment.

Sep 26, 2026

Uploaded by Connor