Docstoc

Kuehne Nagel Industrie und Handelskammer Hannover

Document Sample
Kuehne Nagel Industrie und Handelskammer Hannover Powered By Docstoc
					Kuehne + Nagel

Medical Forum USA – Logistics – Customs Formalities and Import

IHK Hannover – November 2011
Agenda

     Kuehne + Nagel Introduction

     FDA and Export Shipment Preparation

     U.S. Import Process

     Contract Logistics & QSHE

     Pharma Market Overview

Kuehne + Nagel – IHK November 2011         2
The Global Logistics Network


     Worldwide network - 900 locations in more than 100 countries

     Integrated service portfolio – more than 62,000 employees

     7 million m2 warehousing space




Kuehne + Nagel – IHK November 2011                                  3
Market Position
                           Global No. 1 in Seafreight
                              Value creating service portfolio
                              Leading the industry with IT-based solutions
                              Strong partnerships with preferred carriers

                           Global Top 3 in Airfreight
                              Well positioned in the top league
                              Cargo 2000 Phase II certified (first mover!)
                              Strong partnerships with preferred airlines

                           Global Top 3 in Contract Logistics
                              Global infrastructure for global contract logistics coverage
                              Dedicated and shared warehousing & distribution
                              management
                              Transportation management solutions

                           Top 6 in European Road & Rail Logistics
                              Focus on network services, LTL & FTL business
                              Pan-European coverage of 38 countries
                              Innovative intermodal solutions
Kuehne + Nagel – IHK November 2011                                                           4
Comprehensive Global Logistics Solutions

Sea & Air Logistics                  Special Services
   Seafreight                           Aviation Logistics
   Airfreight                           Drinks Logistics
Road & Rail Logistics                   Emergency & Relief Logistics
   Road                                 Fairs & Exhibition Logistics
   Rail                                 Forest Logistics
Contract Logistics                      Hotel Logistics
   Warehousing                          Marine Logistics
   Distribution                         Oil & Gas Logistics
   Value-added services                 Perishables Logistics
                                        Pharma/ Healthcare
Lead Logistics
   End-to-End Execution                 Project Logistics
   Managed Integrated Solutions
                                     Insurance Brokerage

Kuehne + Nagel – IHK November 2011                                     5
Kuehne + Nagel Global Regions



                                     Northwest Europe
                                                                              Eastern Europe


                                                        Central Europe
North America                          Southwest
                                       Europe

                                                                                               Asia Pacific
                                                                     Middle
                                                                     East

                                                   Africa
                 Central and
                 South America




Kuehne + Nagel – IHK November 2011                                                                            6
Kuehne + Nagel in Germany

 Locations                over 100

 Employees                over 10,000

 Products                 • Air- and Seafreight
 and                      • Customs Brokerage
                          • Contract Logistics
 Services                 • Distribution
                          • European Overland
                            and Barge Transports
                          • Information Technology




                                                     Kuehne+Nagel
                                                     Locations



Kuehne + Nagel – IHK November 2011                                  7
Kuehne + Nagel in the U.S.

 Locations                around 85
                                                               Contract Logistics Centres
                          HQ Jersey City, NJ
                                                               Freight Forwarding Offices
 Employees                over 3,600
                          (Germans in almost every location)

 Products                 • Air- and Seafreight
 and                      • Customs Brokerage
                          • Contract Logistics
 Services                 • Distribution
                          • Overland and Barge
                            Transports
                          • Information Technology




Kuehne + Nagel – IHK November 2011                                                     8
Agenda

     Kuehne + Nagel Introduction

     FDA and Export Shipment Preparation

     U.S. Import Process

     Contract Logistics

     Pharma Market Overview

Kuehne + Nagel – IHK November 2011         9
U.S. Food and Drug Administration (FDA)
Medical Device Registration and Listing
      Establishments that are involved in the production, sale and
      distribution of medical devices intended for commercial distribution in
      the United States are required to
           register annually with the FDA
           list the devices and the activities performed on those devices

      In addition, the foreign manufacturers must designate a U.S. agent
      As with domestic manufacturers, foreign manufacturing sites are
      subject to FDA inspection

      Information on U.S. regulatory requirements can be found on
      the FDA’s website
           http://www.fda.gov/MedicalDevices/default.htm


Kuehne + Nagel – IHK November 2011                                              10
Export Shipment Preparation
Automated Manifest Systems (AMS)
      AMS is the manifesting of cargo 24 hours prior to loading at the origin
      seaport for shipments destined to the United States
           Same applies for cargo entering the U.S. via Canada or
           Freight remaining on board (FROB) that touches a U.S. port
      AMS speeds the flow of cargo and entry processing and provides
      participants with electronic authorization to move cargo
      Carriers, port authorities, service bureaus, freight forwarders and
      seacontainer freight stations can participate in AMS
      Penalties are in place for not filing, filing on time or filing an
      amendment after the vessel's departure from origin




Kuehne + Nagel – IHK November 2011                                              11
Export Shipment Preparation
Import Security Filing (ISF)
      U.S. Customs and Border Protection has issued a proposed rule that
      will require information from importers and carriers for vessel cargo
      before it is brought directly into the U.S.
      This additional information will further improve the ability to identify
      high-risk shipments in order to prevent smuggling and ensure cargo
      safety and security
      Importer of Record (IOR) is responsible for filing multiple data
      elements 24 hours prior to loading of container on vessel at seaport of
      loading




Kuehne + Nagel – IHK November 2011                                           12
Export Shipment Preparation
Import Security Filing (ISF) / „10+2“
   1. Seller‘s name and complete address
   2. Buyer‘s name and complete address
   3. Importer IRS or customs assigned number
   4. Consignee IRS number
   5. Manufacturer‘s name and complete address
   6. Ship-to name and address                   Importer
   7. Country of origin
   8. US-HTS number (min. 6-digit)
   9. Consolidator name and address
   10. Complete container stuffing location
   11. Container stowage plan
                                     Carrier
   12. Container status


Kuehne + Nagel – IHK November 2011                          13
Export Shipment Preparation
Incoterms



 Silke Cappelletti

 NACORA
 Versicherungsmakler GmbH
 Großer Grasbrook 11 – 13
 DE - 20457 Hamburg

 Tel: +49 (0)40 376905 26
 Mob: +49 (0)172 422 69 93
 E-Mail: silke.cappelletti@nacora.com




Kuehne + Nagel – IHK November 2011      14
Agenda

     Kuehne + Nagel Introduction

     FDA and Export Shipment Preparation

     U.S. Import Process

     Contract Logistics & QSHE

     Pharma Market Overview

Kuehne + Nagel – IHK November 2011         15
U.S. Import Process
Customs Brokerage
      Air/ sea data migrated into C.B. systems for entry processing
      Local entry filing
      RLF entry filing
           Remote Location Filing (RLF) allows approved participants to electronically
           file entries from a location within the U.S. other than the port of arrival or
           location of examination.
      EIP local entry
           Electronic Invoice Program (EIP) allows filers to submit invoices
           electronically; pre-requisite for RLF
      Reconciliation entry filing
           Allows for post-entry revisions to certain elements of entries which are
           indeterminable at time of entry

      Local control of business, no matter which port of entry is concerned
      Your goods available – quickly and in compliance

Kuehne + Nagel – IHK November 2011                                                     16
U.S. Import Process
Power of Attorney
      The Power of Attorney (POA) is an authorization signed by the
      Importer of Record (IOR) to nominate Kuehne + Nagel as their
      customs broker
      Original signed validated POA is required for every import shipment
      In case delivery terms are DDP, the IOR would be the shipper and a
      Foreign Power of Attorney (FPOA) has to be signed
           Issuing a FPOA could take several days up to weeks – sign prior to
           shipment




Kuehne + Nagel – IHK November 2011                                              17
U.S. Import Process
Bonds are…
      …in place to guarantee payments of import duties, taxes and assure
      compliance with all laws and regulations
      …financial guarantees that all obligations to the U.S. Customs Service
      will be met and should not be confused with insurance
      …available in various forms/ types of bonds to cover specific situations
      and types of goods
           Single Transaction Bond
           Continuous Bond

      The Bond Application Form should be submitted before shipment




Kuehne + Nagel – IHK November 2011                                           18
Import Shipment Support
Contacts
      Kuehne + Nagel‘s Strategic Trade Group supports our customers
           by addressing complex issues related to their legal obligations as importers
           and exporters,
           by becoming compliant with all regulatory requirements and
           by protecting their business from government sanction and business losses
           due to clearance delays and recalls

      BVL - Bundesvereinigung Logistik
      FDA - Food and Drug Administration
      IHK - Industrie- und Handelskammer
      USDA - United States Department of Agriculture
      GDP Guidelanes – New EU GDP Guidelines-draft



Kuehne + Nagel – IHK November 2011                                                   19
Agenda

     Kuehne + Nagel Introduction

     FDA and Export Shipment Preparation

     U.S. Import Process

     Contract Logistics & QSHE

     Pharma Market Overview

Kuehne + Nagel – IHK November 2011         20
Contract Logistics
Expanding the Global Network



                          60 countries
                          500 locations
                          7 million m2 of warehouse space
                          34,000 employees




Kuehne + Nagel – IHK November 2011                          21
Contract Logistics Locations
Germany

                                          Hamburg




                                       • Hannover

                                                                        • Berlin

                                                            • Leipzig              • Locations        Number   Total m²
                                      • Kassel
                                                                                      •   Shared        29       537,301
                        • Frankfurt
                                                                                      •   Dedicated     45       812,600
                                                                                      •   Total         74     1,349,901


                              • Stuttgart




                                                 • Munich




■ Regional + National Headquarters ● Shared Warehouse ● Dedicated Warehouse




Kuehne + Nagel – IHK November 2011                                                                                    22
Contract Logistics Locations
United States




Kuehne + Nagel – IHK November 2011   23
Contract Logistics
Innovative Integrated Solutions
                   Inbound Logistics                          In-house Logistics
                                                                 Multi-user operations
                   Collection services                           Dedicated operations
                   Milk runs                                     VMI / SMI
                   Tracking & tracing                            Production logistics
                   Carrier management                            Kitting
                   Customs brokerage                             Value-added services
                                                                 Light sub-assembly




                   Reverse Logistics                     Distribution           Logistics

                   Container management                          Pick / pack / ship
                   Returns management                            Inbound
                   Critical service parts management             Outbound
                   Cartridge collection and sorting              Network design
                   Screening / testing                           Transport management
                   Re-working, re-packing, re-labeling           Container management
                   Repair management                             Cross docking




Kuehne + Nagel – IHK November 2011                                                          24
Contract Logistics
Additional Value Added Services
      Product labeling, tagging, repackaging and skidding
      Quality control/ product inspection
      Emergency storage for business continuity plan
      High security distribution planning and coordination
      Validated WMS system
      Loading of product into pre-conditioned shipping containers/ trailers
      Temperature and humidity monitoring
      KPI monitoring
      Recall assistance and tracing
      GXP Facilities which are Verified-Accredited Wholesale Distributors
      (VAWD) accredited by the National Association of Boards of Pharmacy



Kuehne + Nagel – IHK November 2011                                        25
Quality Management and Certifications

         Q = Quality Standard ISO 9001:2000
         SH = Safety & Health Standard OHSAS 18001:2007
         E = Environment Standard ISO 14001 :2004
         S = Security Standards
              General Security
              –     TAPA „Technology Asset Protection Association“
              Customs Security
              –     C-TPAT „Customs Trade Partnership Against Terrorism“
              –     Security Requirements for US-shipments
              Airfreight Security Requirements
              – Cargo 2000, AEO, QEP
              Pharma Industry
              – GxP, GMP, GDP
              Chemical Industry
              – SQAS

Kuehne + Nagel – IHK November 2011                                         26
Various Certificatations
C-TPAT Certification
      Kuehne + Nagel, Inc. is C-TPAT
      certified in following business fields:
           Customs Brokerage
           NVOCC
           Ocean Transportation Intermediary
           Air Freight Consolidator




Kuehne + Nagel – IHK November 2011              27
Airfreight Security Process
TSA Cargo Screening Initiative
      Applicable for all shipments on US carriers’ passenger flights in- and
      outbound of the USA
      Screening possible through manufacturer/ warehouse/ freight
      forwarder or airline as long as certain criteria Certified Cargo
      Screening Program (CCSP) is being met (outbound)

                        9/11 Act           50%            100%

                   August 2007        February 2009    August 2010

      Consequences for air freight customers
           Cargo back log
           Longer transit times
           Additional costs
           More handling     higher damage ratio


Kuehne + Nagel – IHK November 2011                                             28
Airfreight Security Process
TSA Cargo Screening Initiative
      Kuehne + Nagel participates since 2009 in the Certified Cargo
      Screening Program
      Multiple U.S. branches/ gateways have been certified
      Kuehne + Nagel participates in the Screening Technology Pilot (STP)
      Program
           Development of further non-intrusive screening methods

      Advantages for Kuehne + Nagel customers
           Less time needed since Kuehne + Nagel
           hands already screened cargo over to airlines
           Foreseeable costs
           One-Stop-Shopping
             – Less coordination and handling
             – Minimized cargo damage risk

Kuehne + Nagel – IHK November 2011                                          29
Seafreight Security Process
Seals, Screening and IPPC
      High Security Container Seals
           Since 15th October 2008 every container entering the U.S.
           (via sea, road or rail) needs to be secured with ISO/PAS
           17712 certified seals
           C-TPAT certified seals

      100% Container Screening
           Delayed until 2012 due to resistance from the EU
           Estimated costs over min. 2.5 bn USD per year
           (source World Customs Organization)

      IPPC (International Plant Protection Convention)
      standard for all wood packaging incl. Euro-pallets


Kuehne + Nagel – IHK November 2011                                     30
Agenda

     Kuehne + Nagel Introduction

     FDA and Export Shipment Preparation

     U.S. Import Process

     Contract Logistics & QSHE

     Pharma Market Overview

Kuehne + Nagel – IHK November 2011         31
Pharma/ Healthcare Industry
The Global Pharmaceutical Market
      With 37% of global pharmaceutical sales, the U.S. is the largest market
      worldwide
      The U.S. pharmaceutical market grew at an annual average of just over
      4% from 2005-2010; for 2010-2015, BMI forecasts a CAGR* of 1.6%
     Global Pharmaceutical Sales ($)       Expected Market Growth in 2011
                                                                    2011        2011-2015

                                              Global Market         4-5%          3-6%

                                              North America         2-3%          0-3%

                                              Europe                2-3%          2-5%

                                              Asia/Africa/
                                                                   12-13%        11-14%
                                              Australia

                                              Japan                 5-6%          2-5%

                                              Latin America        11-12%        11-14%


                                                         *Compound Annual Growth Rate / Source: IMS Health

Kuehne + Nagel – IHK November 2011                                                                 32
Pharma/ Healthcare Industry
Share of Temperatur Controlled Shipments (Tonnage)
      About a quarter of all pharma shipments (tonnage) is temperature
      controlled




Kuehne + Nagel – IHK November 2011                                       33
Pharma/ Healthcare Industry
Manufacturing Sites of the Top Pharmaceutical Companies



                                                          Novartis

                                                          AstraZeneca

                                                          Bayer HealthCare

                                                          Sanofi

                                                          Becton Dickinson

                                                          Glaxo Smith Kline

                                                          Roche

                                                          Eli Lilly

                                                          Pfizer

                                                          Merck & Co

                                                          Johnson & Johnson

                                                          Amgen

                                                          Teva Pharmaceutical


                                                source: Company websites

Kuehne + Nagel – IHK November 2011                                     34
Contract Logistics
European vs. U.S. Warehousing Rents
    Rent developments have been mixed since the beginning of 2011

    Whereas Paris, Detroit and Atlanta have seen increases compared to
    the previous quarter, other regions remained flat or decreased slightly
 Europe Warehousing Rents                 US Warehousing Rents




                                                                 Source: Transport Intelligence / Colliers


Kuehne + Nagel – IHK November 2011                                                                  35
Kuehne + Nagel Pharma/ Healthcare Vision



 Kuehne + Nagel is recognized as the leading global
 provider of logistics and supply chain solutions by the
 largest multi-national Pharma/ Healthcare enterprises.

 Our goal is to create a market leading position based
 on Quality, Global Coverage, Strategic Partners and
 Innovation.

 Kuehne + Nagel will meet and exceed its customers’
 logistics expectations today and be a driving force for
 the Life Sciences Industry in the future

 We are the extension of your business.




Kuehne + Nagel – IHK November 2011                         36
Kuehne + Nagel Pharma/ Healthcare Portfolio
Fields of Expertise




Kuehne + Nagel – IHK November 2011            37
Pharma/ Healthcare – References Contract Logistics
                                     Medical devices    Consumer
     Pharmaceuticals
                                      and services      Healthcare




    In total >100 pharma customers in Kuehne + Nagel Contract Logistics
Kuehne + Nagel – IHK November 2011                                        38
                  And what can we do for you?




Kirsten Sander              Andrea Rucker                 André Affeldt               Hans-Werner Meyer           Michael Schaub
Traffic Manager –           Key Account Management        Route Sales Development     Seafreight Sales            Global Key Account Manager
Seafreight Export FCL       Military Logistics + Public   Manager USA Westbound
                            Sector Central Europe
Bremen                      Frankfurt                     Hamburg                     Hannover                    Frankfurt am Main
Tel: +49 (0)421 3605 2752   Tel: +49 (0)69 4004 464       Tel: +49 (0)40 30333 8464   Tel: +49 (0)511 4602 244    Tel: +49 (0)69 4004 617
Mob: +49 (0)172 445 35 05   Mob: +49 (0)174 150 31 82     Mob: +49 (0)174 941 52 01   Mob: +49 (0)172 441 54 75   Mob: +49 (0)172 400 500 34
kirsten.sander@             andrea.rucker@                andre.affeldt@              hans.werner.meyer@          michael.schaub@
kuehne-nagel.com            kuehne-nagel.com              kuehne-nagel.com            kuehne-nagel.com            kuehne-nagel.com




   Kuehne + Nagel – IHK November 2011                                                                                                  39

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:22
posted:11/5/2012
language:Unknown
pages:39