World Courier (UK) - Business Review Webinars

______________________________________________________________________________________________________________________________________________Importing Pharmaceuticals intothe United StatesStreamlining the processto shorten timelinesand reduce costsPeter Pinto, CCSLicensed Customs House BrokerFebruary 14, 2012© World Courier Management Inc., 2012. All Rights Reserved. Use, Duplication or Sale of this product authorized in writing by WorldCourier Management Inc. is strictly Prohibited. This product contains proprietary information of World Courier Management Inc.

______________________________________________________________________________________________________________________________________________ObjectivesObtain information to meetdocumentation requirements.Understanding FDArequirements and guidanceon FDA detentions.The import release processwaysto avoid/overcomemistakes/delays.

______________________________________________________________________________________________________________________________________________Customs Power of AttorneyA Customs Power of Attorney enables anagent or attorney to conduct CustomsBusiness on behalf of the principal.Customs business.A requirement for any formal entry.Some shipments may not require aPower of Attorney.

______________________________________________________________________________________________________________________________________________Customs BondsContinuous BondSingle-Entry BondEffective in: 10 to 14 days.Effective in: Hours or daysExpedited doc review process.Cost efficient for multiple imports.Entry document requiredCan be costly, due to high premiumsSuits the infrequent importer.Good for one year.Only valid for one shipment.Renewed annually, unlesstermination requested.High value SEB’s could requirecollateral, audited financials or ageneral indemnity agreement.

______________________________________________________________________________________________________________________________________________Commercial Invoice• An adequate description of themerchandise.• Quantities of the merchandise.INVOICEREQUIREMENTS• Values or approximate values of themerchandise, per line item.• Name/address of the seller, buyer andultimate consignee.• Country of origin.• Shipping terms/INCOTERMS.

______________________________________________________________________________________________________________________________________________Valuehttp://www.cbp.gov/linkhandler/cgov/trade/legal/informed_compliance_pubs/icp001r2.ctt/icp001r2.pdfINFORMED COMPLIANCE PUBLICATION

Invoice Template______________________________________________________________________________________________________________________________________________

______________________________________________________________________________________________________________________________________________USDA StatementsThe USDA has a system of guidelines.http://www.aphis.usda.gov/import_export/animals/animal_import/animal_imports_nopermit.shtmlMaterials that do not require a USDA importpermit must fall within a guideline.If no guideline is met than apermit may be required.

______________________________________________________________________________________________________________________________________________Guideline Example – 1105CHEMICALLY SYNTHESIZED MATERIALS

______________________________________________________________________________________________________________________________________________The FDAWith the exception of most meatand poultry, all food, drugs, biologics,cosmetics, medical devices, andelectronic products that emit radiation,as defined in the FD&C and relatedActs, are subject to examination byFDA when they are being imported oroffered for import into the UnitedStates.www.fda.gov

______________________________________________________________________________________________________________________________________________The End Use LetterContainsrelevantinformationfor the FDAreviewer atthe port levelto determineadmissibility.• Shipper/Seller/Manufacturer• Importer of Record/UltimateConsignee• Materials shipped andquantity• The END USE!• Affirmation ofCompliance/Parties

End Use Letter Sample/Template______________________________________________________________________________________________________________________________________________

______________________________________________________________________________________________________________________________________________FDA Product Code Builderhttp://www.accessdata.fda.gov/scripts/ora/pcb/pcb.cfmFDA Product Code is Seven Characters Long♦♦♦♦♦INDUSTRYCLASSSUBCLASSPROCESS INDICATOR CODEPRODUCT

______________________________________________________________________________________________________________________________________________Import Release Process• Documentation complete?• Wheels up?• Transmit!• Entry certified?• Customs / USDA released?• FDA review!QUARANTINE!

______________________________________________________________________________________________________________________________________________Quarantine!No 50-mile radius rule!FDA may be able to examine on site.Redelivery may be requested to the port..Store properly, but keep the packaging!

______________________________________________________________________________________________________________________________________________The FDA Process Flow Chart( Notice of Action )

______________________________________________________________________________________________________________________________________________FDA DetentionEntry is escalated when an appearance of a violation ispresent.Appearance is a standard of evidence.FDA has discretion to what amounts to an appearance.NOTICE OF ACTION ISSUEDNotices are issued to illustrate the violation and providea course of action to move towards release.

______________________________________________________________________________________________________________________________________________FDA RefusalIf it appears from the examination of samples or otherwise that:I. Article manufactured, processed, packed under insanitary conditions.II.III.Article forbidden or restricted in sale in the country in which it wasproduced or from which it was exported.Article is adulterated or misbranded or unapproved.The article will be refused admission!

______________________________________________________________________________________________________________________________________________Case Studies: X, Y and ZThree Case Studies, Notices of Action1. Importer X had an IND typo.2. Importer Y required relabeling per CFR.3. Importer Z changed the drug name.Being proactive can save the day!

QUESTIONS?______________________________________________________________________________________________________________________________________________

______________________________________________________________________________________________________________________________________________Email ContactPeter PintoLicensed Customs House Brokerppinto@worldcustomsbrokerage.com

Importing into China & RussiaSimon BeaumontWorld Courier UK

Introduction• Different Regulatory bodies• Logistical Challenges• Managing risk

China Market Overview• Pharmaceutical marketgrowing at 20% p.a• By end of 2011 expected tobe 3 rd place inpharmaceutical market• Increase capital injection• Abundant & unique diseaseresources• Underdeveloped healthcaresystem

China Market Overview• Large patient pool (1.3 +billion population)• Fast recruitment• 70,000 hospitals, 105,000physicians, 130 medicalschools, 400 researchinstitutes and over 3,000pharmaceutical enterprises• Competitive R&D costs

China – Regulatory Bodies• SFDA – State Food & DrugAdministration - Issues ClinicalTrial Approval• BDA – Beijing DrugAdministration - Issues ImportPermit• SFDA – Shanghai Food & DrugAdministration - Issues ImportPermit• China Inspection & Quarantine

China – Shipper Paperwork• Commercial Invoice• CoA• Packing List• Non Wood Declaration

China – Importer Paperwork• Original Clinical Trial Approval• Import Permit• Power of Attorney• Customs and CIQ RegistrationNumberImporting Comparators:• Copy of Protocol

China – Logistical Challenges• 9.6 million square km• Stretches across 4 time zones• Temperatures range from +40Cto -20C• Remote inland locations

Polling Question• Q. Have you had a positive experience shipping to China?.

Russia – Market Overview• Fall in clinical trial approvals• Ranked 8 th in globalpharmaceutical market• Market relies heavily onimported medicines• Foreign manufacturers

Russia – Regulatory Bodies• Ministry of Health and SocialDevelopment of RussianFederation – Issues StudyRegulatory Approval• Ministry of Health and SocialDevelopment of RussianFederation– Issues ImportLicense

Russia – Logistical Challenges• 17 million square km• Largest country in World• Stretches across 9 timezones• Large variations intemperature

Russia – Shipper Paperwork• Proforma InvoiceAnd on request:• Copy of product labels• CoA

Russia – IOR Paperwork• Stamped copy of StudyRegulatory Approval• Original Import License• Stamped Protocol• Stamped Invoice translated inRussianFor Russian Entities:• Copy of Clinical ResearchServices Agreement• Passport of Deal

Polling Question• Q. Have you had a positive experience shipping to Russia?.

China & Russia – Managing Risk• Good communications• OK TO SEND process• Minimize risk of ‘localinterpretations’• Customs Inspections• Utilizing Depot Facilities

Questions?Simon BeaumontNational Operations ManagerWorld Courier (UK) Ltd12th Floor25 Farringdon StreetLondon EC4A 4ABsbeaumont@worldcourier.co.ukTelephone 44 20 7717 1400© World Courier Management Inc., 2010. All Rights Reserved. Use, Duplication or Sale of thisproduct except as authorized in writing by World Courier Management Inc. is strictlyprohibited. This product contains proprietary information of World Courier Management Inc.

Challenges and how to preventdelays Importing into AfricaLeonard N. LazarusWorld Courier SA (PTY) LTD

Summary• Regulatory challenges• Compliance RegulatoryBodies• Logistic Challenges – SiteLocations• Training• Questions

Regulatory Bodies – South Africa• Medicines Control CouncilMCC• Department of veterinary-Animal• Ministry of Health• SA Pharmacy Council• Population 50 million

Paperwork – South Africa• Import permit – MCC• Customs Invoice• Health certificate• Veterinary import certificate forIP containing animal material.• Vat exempt certificate

Kenya• 580 367 sq km’s in size• Estimated population of 41million people• GDP 66.03 billion (2010estimate) – Agriculture 22% ,Industry 16% and Services 62%• Labour force of 17.9 million• Major Cities Nairobi andMombasa

Regulatory Bodies - Kenya• Kenyan Medical ResearchInstitute – KEMRI• Pharmacy and Poisons BoardPPB

Paperwork – Kenya• Import permit – KEMRI – NDA• Customs Invoice• Donation letter

Ethiopia• Food , Medicine &Health careAdministration control - FMHACA• 1 104 300 sq km’s in size• Estimated population of 90 millionpeople• GDP 86.12 billion (2010 estimate) –Agriculture 50% , Industry 11% andServices 39%• Labour force of 37.9 million

Paperwork – Ethiopia• Import permit• Certificate of origin• Donor Certificate (If Applicable)

Challenges• Road infrastructure non existent orpoorly maintained• Political Instability• Corruption• Poorly equipped and inadequatestorage facilities at airports• Site locations

Polling Question• Are you currently conducting clinical trials in Africa?

Opportunities• Average growth forecast at 5%2012-2015• Oil , Gas and Agri sectors amongstthe fastest growth industries• Over 50% of the worlds mineralsare in Africa

Site in – Entebbe Uganda

Traffic

Training in – Entebbe - Nairobi

Kisumu - Old Airport

Kisumu - New Airport

Avoiding Delays• Comply with Regulatory• Ensure all permits in place• Know site location from Main centre• Prequalified packing

Questions?Leonard N. LazarusNational Sales & Marketing ManagerWorld Courier SA (PTY) Ltd38 Albatross streetRhodesfieldKempton Park 1619leonard@worldcourier.co.zaTelephone 27 11 394 3880© World Courier Management Inc., 2009. All Rights Reserved. Use, Duplication or Sale of this product except as authorized in writing by World CourierManagement Inc. is strictly prohibited. This product contains proprietary information of World Courier Management Inc.

Questions?Today’s presenters have been:Simon Beaumont - National Operations Manager World Courier (UK) Ltdsbeaumont@worldcourier.co.ukLeonard N. Lazarus - National Sales & Marketing Managerleonard@worldcourier.co.zaPeter Pinto - Licensed Customs House Brokerppinto@worldcustomsbrokerage.com© World Courier Management Inc., 2010. All Rights Reserved. Use, Duplication or Sale of thisproduct except as authorized in writing by World Courier Management Inc. is strictlyprohibited. This product contains proprietary information of World Courier Management Inc.