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Pharmacovigilance of Veterinary Medicinal Products

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Pharmacovigilance of Veterinary Medicinal Products a. Reporter Categories Page 1 of 112 Reporter Categories GL42 A.3.1.1. and A.3.2.1. VICH Code VICH TERM VICH DEFINITION C82470 VETERINARIAN Individuals qualified to practice veterinary medicine. C82468 ANIMAL OWNER The owner of the animal or an agent acting on the behalf of the owner. C25741 PHYSICIAN Individuals qualified to practice medicine. C16960 PATIENT The individual(s) (animal or human) exposed to the VMP OTHER HEALTH CARE Health care professional other than specified in list. C53289 PROFESSIONAL C17998 UNKNOWN Not known, not observed, not recorded, or refused b. RA Identifier Codes Page 2 of 112 RA (Regulatory Authorities) Identifier Codes VICH RA Mail/Zip ISO 3166, 3 Character RA Name Street Address City State/County Country Identifier Code Code Country Code 7500 Standish United Food and Drug Administration, Center for USFDACVM Place (HFV-199), Rockville Maryland 20855 States of USA Veterinary Medicine Room 403 America United States Department of Agriculture Animal 1920 Dayton United APHISCVB and Plant Health Inspection Service, Center for Avenue P.O. Box Ames Iowa 50010 States of USA Veterinary Biologic 844 America AGES PharmMed Austrian Medicines and AUTAGESA Schnirchgasse 9 Vienna NA 1030 Austria AUT Medical Devices Agency Eurostation II Federal Agency For Medicines And Health BELFAMHP Victor Hortaplein, Brussel NA 1060 Belgium BEL Products 40 bus 10 7, Shose Bankya BGRIVETP Institute For Control Of Vet Med Prods Sofia NA 1331 Bulgaria BGR Str. CYPVETSE Veterinary Services 1411 Nicosia Nicosia NA 1411 Cyprus CYP Czech CZEUSKVB Uskvbl Hudcova 56a Brno - Medlánky NA 62100 CZE Republic Axel Heides Gade DNKMEDAG Danish Medicines Agency Copenhagen NA 2300 Denmark DNK 1 ESTSAMVP State Agency Of Medicines 1 Nooruse Street Tartu NA 50411 Estonia EST Mannerheiminitie FINAMVET National Agency For Medicines Helsinki NA 301 Finland FIN 103b La Haute Marche FRAANMVF Agence Nationale Du Medicament Veterinaire Fougères Cedex NA 35302 France FRA BP 90203 Javené DEUBVLVP Bundesamt Fuer Verbraucherschutz Mauerstraße 39-42 Berlin NA 10117 Germany DEU DEUPEIVM Paul-Ehrlich-Institut Postfach 1740 Langen NA 63207 Germany DEU 284 Messogion GRCVETPV National Organisation For Medicines Athens NA 15562 Greece GRC Avenue Holargos HUNCAODV Institute For Veterinary Medicinal Product Szállás utca 8 Budapest NA 1107 Hungary HUN ISLMEDAG Lyfjastofnun Icelandic Medicines Control Agency Eiðistorg 13-15 Seltjarnarnes NA IS-170 Iceland ISL Kevin O'Malley House The IRLIMBVM Irish Medicines Board 2 Dublin NA 2 Dublin Ireland IRL Earlsfort Centre Earlsfort Terrace Ministero del Lavoro, della SALUTE e delle Via Giorgio ITADGSA4 Roma NA 144 Italy ITA Politiche Sociali - DGSA - Office IV Ribotta, 5 LVAZVA08 State Agency Of Medicines Jersikas iela 15 Riga NA LV-1013 Latvia LVA b. RA Identifier Codes Page 3 of 112 Amt für Liechtenst LIEKONAR Kontrollstelle Für Arzneimittel Gesundheit Vaduz NA 9490 LIE ein Äulestrasse 51 The State Food and Veterinary Service of LTUINSVE Biruliškes Kauno rajonas NA LT-4301 Lithuania LTU Kaunas County Netherlan NLDCBGBD Bureau Bijwerkingen Diergeneesmiddelen Haagsteeg 2 Wageningen NA 6708 PM NLD ds Sven Oftedals vei NORMAVET Norwegian Medicines Agency Oslo NA N-0950 Norway NOR 6 POLURPLV Office For Medicinal Products ul. Ząbkowska 41 Warszawa NA 03-736 Poland POL PRTDGVFV Direccao Geral De Veterinaria Artes, 2 Lisboa NA 1249-105 Portugal PRT SVNJAZMP Agency For The Medicinal Products Of Slovenia Ptujska ulica 21 Ljubljana NA SI - 1000 Slovenia SVN Edificio 8 ESPAGMED Agencia Espanola De Medicamentos Madrid NA 28022 Spain ESP C/Campezo 1 Dag SWEMEDAG Medical Products Agency Sweden Veterinary Hammarskjölds Uppsala NA 751 83 Sweden SWE väg 42 Woodham Lane United GBRUKVMD Veterinary Medicines Directorate Addlestone Surrey KT15 3LS GBR New Haw Kingdom EUEMA000 European Medicines Agency 7 Westferry Circus London NA E14 4HB United KingGBR JPNJMAFF Ministry of Agriculture, Forestry and Fisheries 1-15-1, Tokura Kokubunji, Tokyo 185-8511 Japan JPN South Tower, 86 Jervois Quay, PO NZLNZFSA New Zealand Food Safety Authority (NZFSA) Box 2835 Wellington New Zeala NZL Australian Pesticides and Veterinary Medicines AUSAPVMA Authority 18 Wormald Street Symonston ACT 2609 Australia AUS CANHCVDD Health Canada, Veterinary Drugs Directorate 11 Holland Avenue Ottawa Ontario K1A 0K9 Canada CAN c. Type of Submission Page 4 of 112 TYPE OF SUBMISSION GL42 A.4.4.1 VICH CODE VICH TERM VICH DEFINITION A report as defined by VICH GL24 - Management of Adverse Event C68624 EXPEDITED Reports A report as defined by VICH GL24 - Management of Adverse Event C53578 PERIODIC Reports C53579 FOLLOW-UP A report as defined by legislation, regulations or guidance documents C68625 NULLIFICATION A report as defined by legislation, regulations or guidance documents The actual value is not an element in the value domain of a variable C17649 OTHER (e.g., concept not provided by required code system). d. Type of Information Page 5 of 112 TYPE OF INFORMATION IN REPORT GL42 A.4.4.3 VICH CODE VICH TERM VICH DEFINITION Any observation in animals or humans, whether or not considered to be product related that is unfavorable and unintended, excluding C82461 SAFETY ISSUE suspected lack of expected effectiveness and that occurs after any use of the veterinary medicinal product(s) (off-label and on-label uses). (As defined by VICH GL24 - Management of Adverse Event Reports) An adverse event in animals that only involves suspected lack of LACK OF EXPECTED C82456 expected effectiveness according to approved labelling after any use of EFFECTIVENESS the veterinary medicinal product(s). (As defined by VICH GL24 - Management of Adverse Event Reports) BOTH SAFETY AND LACK OF An adverse event in animals that involves both safety issue(s) and C82452 EXPECTED EFFECTIVENESS suspected lack of expected effectiveness after any use of the veterinary medicinal product(s). C17649 OTHER The actual value is not an element in the value domain of a variable (e.g., concept not provided by required code system). e. Vet Health Status Assessment Page 6 of 112 ATTENDING VETERINARIAN'S ASSESSMENT OF ANIMAL HEALTH STATUS PRIOR TO EXPOSURE TO VMP GL42 B.1.2.1 VICH CODE VICH TERM VICH Definition C82488 EXCELLENT The condition as defined "excellent" by the attending veterinarian. C64975 GOOD The condition as defined "good" by the attending veterinarian. C82489 FAIR The condition as defined "fair" by the attending veterinarian. C77959 POOR The condition as defined "poor" by the attending veterinarian. C25467 CRITICAL The condition as defined "critical" by the attending veterinarian. C17998 UNKNOWN Not known, not observed, not recorded, or refused C82478 NO ATTENDING VETERINARIAN There was no attending veterinarian for this adverse event. f. Species Page 7of 112 VICH GL30 Species code VICH GL30 Species AGO African Goshawk ALP Alpaca BAD Badger BAT Bat BEA Bear BEV Beaver BEE Bee BIS Bison BIV Bivalves BKI Black Kite BOB Bobcat BUD Budgerigar BUF Buffalo BUS Bustard BUZ Buzzard CAM Camel CAT Cat CTT Cattle CEP Cephalopods CHI Chicken CHM Chimpanzee CHN Chinchilla COC Cockatiel CCK Cockatoo CCA Common Canary COU Cougar CRO Crocodile CRW Crow CRU Crustaceans DOG Dog DOL Dolphin DON Donkey DOR Dormouse DUC Duck EAG Eagle ELK Elk EMU Emu FAL Fallow FER Ferret FIS Fish FOX Fox FRO Frog GER Gerbil GOA Goat f. Species Page 8of 112 GOO Goose GFO Guinea fowl GPI Guinea Pig HAM Hamster HAR Hare HED Hedgehog HOR Horse HUM Human IGU Iguana JAC Jackal JAG Jaguar KES Kestrel KIT Kite LEO Leopard LIO Lion LIZ Lizard LLA Llama LYN Lynx MAC Macaw MAR Marsupial MIN Mink MON Monkey MOO Moose MOU Mouse MUL Mule OST Ostrich OAM Other Amphibians OAR Other Arthropods OBI Other Birds OBO Other Bovine OCA Other Camelids OCN Other Canids OCP Other Caprines OCE Other Cervids ODE Other Deer OEQ Other Equids OFE Other Felids OLE Other Leporids OMA Other Mammals OMM Other marine mammal OMO Other Molluscs OMU Other Mustelids OVI Other Ovids OPO Other Porcine ORE Other Reptiles f. Species Page 9of 112 ORO Other Rodents OWL Owl PAN Panda PAR Parakeet PRR Parrot PRT Partridge PER Peregrin falcon PHE Pheasant PIG Pig PGE Pigeon PRI Primate QUA Quail RAB Rabbit RAC Racoon Dog RAT Rat RED Red Deer REI Reindeer ROE Roe Deer SHE Sheep SNA Snake SNI Snipe SPA Sparrow SPI Spider STA Starling SWA Swan TIG Tiger TOR Tortoise TSU Tsushima wild cat TUR Turkey TRT Turtle TDO Turtle dove VOL Vole WHA Whale WTD White tailed deer WBO Wild Boar WOL Wolf ZEB Zebra g. Breeds Page 10 of 112 SPECIES VICH BREED GL30 BREED NAME Code Alpaca ALP1 Alpaca Alpaca ALP2 Alpaca (other) Alpaca ALP3 Alpaca (unknown) Bivalves BIV1 Bivalves (unspecified) Bivalves BIV2 Blue mussels (Mytilus edulis, Mytilus galloprovincialis) Bivalves BIV3 Clams (Ruditapes decussates, Ruditapes philipinarum, Tapes spp., Veneridae, Mercenaria mercenaria) Bivalves BIV4 Cockles (Cerastoderma edule) Bivalves BIV5 Bivalves (other) Bivalves BIV6 Oysters (Ostreidae) Bivalves BIV7 Scallops (Pectinidae) Bivalves BIV8 Bivalves (unknown) Camel CAM1 Bactrian Camel Camel CAM2 Camel (unspecified) Camel CAM3 Dromedary Camel CAM4 Mixed (Camel) Camel CAM5 Camel (other) Camel CAM6 Camel (unknown) Cat CAT1 Abyssinian cat Cat CAT2 American Bobtail Cat CAT3 American Curl Longhair Cat CAT4 American Curl Shorthair Cat CAT5 American Shorthair Cat CAT6 American Wirehair Cat CAT7 Asian Longhair Cat CAT8 Asian Shorthair Cat CAT9 Balinese Cat CAT10 Bengal Cat CAT11 Birman (Sacred Birman) Cat CAT12 Bombay Cat CAT13 British Blue Cat CAT14 British cat Cat CAT15 Burmese Cat CAT16 Burmilla Cat CAT17 Cat (unknown) Cat CAT18 Chartreuse
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