FDA CVM Vocabularies for VICH HL7 GL42
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FDA CVM Vocabularies for VICH HL7 GL42 Version Details Excel Document Version Number 3 2 Excel Document Date Released October 1, 2013 June 21, 2013 VICH AER Version Number VICHAER1.0.0 VICHAER1.0.0 Date of FDA CVM Implementation November 29, 2013 June 21, 2013 Index Vocabulary Vocabulary List Name List Number a Reporter Categories b RA Identifier Codes c Type of Submission (VICH Terms/Codes and US-specific Terms/Codes) d Type of Information (VICH Terms/Codes and US-specific Terms/Codes) e Vet Health Status Assessment f Species g Breeds h Gender i Reproductive Status j Female Physiological Status k Precision Categories l RA Assessment Categories m Route of Exposure n Units of Presentation o Units of Measurement p Dosage Forms q Administrators of VMP s VeDDRA Terms t Exposure and Onset Time u Vet Causality Assessment v Document Types w Dose Denominator Qualifiers x Accuracy of No. of Animals aa Attached Document Kind bb ICSR Observation Locator Codes cc Explanation for Linkage A.36 ISO 3-Character Country Codes A.20 ATCvet Code – Information Only A.35 US States & Territory Codes (US Only) A.5 Domestic and Foreign Report Categories (US Only) A.26 Profile Identifier Code Vocabulary (US Only) A.34 Report Identifier (US Only) A.29 List of Package Types (US Only) A.42 National Drug Codes System (US Only) A.38 Substance Registration System Active Ingredient Codes (US Only) A.28 ORA District Field Offices (US Only) A.43 FDA CVM Internal Product Problem/Medication Error Terms (US Only) A.44 FDA CVM Internal Adverse Event Terms (US Only) A.18 List of Manufacturer Site Identifiers (US Only) Index OID 2.16.840.1.113883.13.194 no OID needed 2.16.840.1.113883.13.195 2.16.840.1.113883.13.196 2.16.840.1.113883.13.197 2.16.840.1.113883.4.341 2.16.840.1.113883.4.342 2.16.840.1.113883.13.198 2.16.840.1.113883.13.199 2.16.840.1.113883.13.49 2.16.840.1.113883.13.200 2.16.840.1.113883.13.201 2.16.840.1.113883.13.202 2.16.840.1.113883.13.203 2.16.840.1.113883.6.8 2.16.840.1.113883.13.205 2.16.840.1.113883.13.208 2.16.840.1.113883.4.358 2.16.840.1.113883.13.50 2.16.840.1.113883.13.210 2.16.840.1.113883.13.211 2.16.840.1.113883.13.204 2.16.840.1.113883.13.209 no OID needed 2.16.840.1.113883.13.206 2.16.840.1.113883.13.219 no OID needed no OID needed no OID needed 2.16.840.1.113883.13.212 2.16.840.1.113883.13.207 no OID needed 2.16.840.1.113883.13.213 2.16.840.1.113883.6.69 2.16.840.1.113883.4.9 2.16.840.1.113883.3.1891 2.16.840.1.113883.13.226 2.16.840.1.113883.13.227 no OID needed Change History Date Tag Operation 06/21/13 All 10/01/13 d Modified 10/01/13 s Added 10/01/13 A.43 FDA PP Added 05/20/14 d Modified 05/20/14 g Modified 05/20/14 m Modified 05/20/14 p Modified 08/13/15 s Modified 08/13/15 A.36 ISO-Country Modified Change History Description Notes Baseline for Version 2 Revised definitions for C82453, C82454, and C82455 No change to code or term VeDDRA V.10 14 terms Revised definition for C82454 Clinical Studies No change to code or term Added "Horse" to species column for HOR143 Yonaguni No change to code or term Corrected definition for C38288 Oral No change to code or term Removed duplicate terms with blank definitions that were marked as "Inactive"No change to code or term Added VeDDRA V.11; marked V.7 and V.6 as Inactive No change to code; term not Modified term TAIWAN to conform with GENC in NSG Standards Registry transmitted in xml a. Reporter Categories Page 6 of 221 Reporter Categories VocabularyOID 2.16.840.1.113883.13.194 CreateDate 6/22/2010 LatestVersion See Column E 1 ReleaseDate See Column E 06/21/2013 CODE TERM DEFINITION SOURCE STATUS C82470 VETERINARIAN Individuals qualified to practice veterinary VICH Active medicine. C82468 ANIMAL OWNER The owner of the animal or an agent acting on the VICH Active behalf of the owner. C25741 PHYSICIAN Individuals qualified to practice medicine. VICH Active C16960 PATIENT The individual(s) (animal or human) exposed to theVICH Active VMP C53289 OTHER HEALTH CARE Health care professional other than specified in list.VICH Active PROFESSIONAL C17998 UNKNOWN Not known, not observed, not recorded, or refused VICH Active C17649 OTHER Different than the one(s) previously specified or FDA Active mentioned b. RA Identifier Codes Page 7 of 221 RA Identifier Codes VocabularyOID no OID needed CreateDate 6/22/2010 LatestVersion See Column J 1 ReleaseDate See Column J 06/21/2013 VICH RA Identifier RA Name Street Address City State/ Mail/Zip Country ISO 3166, 3 Character SOURCE STATUS Code County Code Country Code USFDACVM Food and Drug Administration, Center for 7500 Standish Place Rockville MD 20855 United USA VICH Active Veterinary Medicine (HFV-199), Room 403 States of America APHISCVB United States Department of Agriculture 1920 Dayton Avenue Ames IA 50010 United USA VICH Active Animal and Plant Health Inspection Service, P.O. Box 844 States of Center for Veterinary Biologic America AUTAGESA AGES PharmMed Austrian Medicines and Schnirchgasse 9 Vienna NA 1030 Austria AUT VICH Active Medical Devices Agency BELFAMHP Federal Agency For Medicines And Health Eurostation II Victor Brussel NA 1060 Belgium BEL VICH Active Products Hortaplein, 40 bus 10 BGRIVETP Institute For Control Of Vet Med Prods 7, Shose Bankya Str. Sofia NA 1331 Bulgaria BGR VICH Active CYPVETSE Veterinary Services 1411 Nicosia Nicosia NA 1411 Cyprus CYP VICH Active CZEUSKVB Uskvbl Hudcova 56a Brno - NA 62100 Czech CZE VICH Active Medlánky Republic DNKMEDAG Danish Medicines Agency Axel Heides Gade 1 Copenhagen NA 2300 Denmark DNK VICH Active ESTSAMVP State Agency Of Medicines 1 Nooruse Street Tartu NA 50411 Estonia EST VICH Active FINAMVET National Agency For Medicines Mannerheiminitie 103b Helsinki NA 301 Finland FIN VICH Active FRAANMVF Agence Nationale Du Medicament Veterinaire La Haute Marche BP Fougères NA 35302 France FRA VICH Active 90203 Javené Cedex DEUBVLVP Bundesamt Fuer Verbraucherschutz Mauerstraße 39-42 Berlin NA 10117 Germany DEU VICH Active DEUPEIVM Paul-Ehrlich-Institut Postfach 1740 Langen NA 63207 Germany DEU VICH Active GRCVETPV National Organisation For Medicines 284 Messogion Avenue Athens NA 15562 Greece GRC VICH Active Holargos HUNCAODV Institute For Veterinary Medicinal Product Szállás utca 8 Budapest NA 1107 Hungary HUN VICH Active ISLMEDAG Lyfjastofnun Icelandic Medicines Control Eiðistorg 13-15 SeltjarnarnesNA IS-170 Iceland ISL VICH Active Agency IRLIMBVM Irish Medicines Board Kevin O'Malley House 2 Dublin NA 2 Dublin Ireland IRL VICH Active The Earlsfort Centre Earlsfort Terrace ITADGSA4 Ministero del Lavoro, della SALUTE e delle Via Giorgio Ribotta, 5 Roma NA 144 Italy ITA VICH Active Politiche Sociali - DGSA - Office IV LVAZVA08 State Agency Of Medicines Jersikas iela 15 Riga NA LV-1013 Latvia LVA VICH Active b. RA Identifier Codes Page 8 of 221 LIEKONAR Kontrollstelle Für Arzneimittel Amt für Gesundheit Vaduz NA 9490 Liechtenste LIE VICH Active Äulestrasse 51 in LTUINSVE The State Food and Veterinary Service of Biruliškes Kauno NA LT-4301 Lithuania LTU VICH Active Kaunas County rajonas NLDCBGBD Bureau Bijwerkingen Diergeneesmiddelen Haagsteeg 2 Wageningen NA 6708 PM NetherlandsNLD VICH Active NORMAVET Norwegian Medicines Agency Sven Oftedals vei 6 Oslo NA N-0950 Norway NOR VICH Active POLURPLV Office For Medicinal Products ul. Ząbkowska 41 Warszawa NA 03-736 Poland POL VICH Active PRTDGVFV Direccao Geral De Veterinaria Artes, 2 Lisboa NA 1249-105 Portugal PRT VICH Active SVNJAZMP Agency For The Medicinal Products Of Ptujska ulica 21 Ljubljana NA SI - 1000 Slovenia SVN VICH Active Slovenia ESPAGMED Agencia Espanola De Medicamentos Edificio 8 C/Campezo 1 Madrid NA 28022 Spain ESP VICH Active SWEMEDAG Medical Products Agency Sweden Veterinary Dag Hammarskjölds väg Uppsala NA 751 83 Sweden SWE VICH Active 42 GBRUKVMD Veterinary Medicines Directorate Woodham Lane New Addlestone Surrey KT15 3LSUnited GBR VICH Active Haw Kingdom EUEMA000 European Medicines Agency 7 Westferry Circus London NA E14 4HB United GBR VICH Active Kingdom JPNJMAFF Ministry of Agriculture, Forestry and Fisheries 1-15-1, Tokura Kokubunji, 185-8511Japan JPN VICH Inactive Tokyo NZLNZFSA New Zealand Food Safety Authority (NZFSA) South Tower, 86 Jervois Wellington New NZL VICH Inactive Quay, PO Box 2835 Zealand AUSAPVMA Australian Pesticides and Veterinary 18 Wormald Street Symonston ACT 2609 Australia AUS VICH Active Medicines Authority CANHCVDD Health Canada, Veterinary Drugs Directorate 11 Holland Avenue Ottawa Ontario K1A 0K9 Canada CAN VICH Active CFIACCVB Canadian Food Inspection Agency, Canadian 59 Camelot Drive Ottawa Ontario K1A 0Y9 Canada CAN VICH Active Centre for Veterinary Biologics UNSPECIF RA Name for countries without a defined code Provide address Provide City Provide StateProvide PostalProvide Code Provide Country Code or VICH Active for the RA Identifier Country ZZZ if no existing Country Code MAFFNVAL Ministry of Agriculture, Forestry and Fisheries, 1-15-1, Tokura Kokubunji, 185-8511Japan JPN VICH Active National Veterinary Assay Laboratory Tokyo USEPAEPA Environmental Protection Agency Office of Pesticide Washington, 20460 United USA VICH Active Programs (7504C), Ariel DC States of Rios Building, 1200 America Pennsylvania Ave. NW b. RA Identifier Codes Page 9 of 221 CAHCPMRA Health Canada, Pest Management Regulatory 2720 Riverside Drive Ottawa Ontario K1A 0K9 Canada CAN VICH Active Agency NZLNZMPI Ministry for Primary Industries Pastoral House, PO Box Wellington New NZL VICH Active 2526 6011 Zealand c.