prof. Jozef Bires, DVM, DSc. Chief Veterinary Officer The State Veterinary and Food Administration of the SR

prof. Jozef Bires, DVM, DSc. Chief Veterinary Officer The State Veterinary and Food Administration of the SR

Slovakia has a population of over five and a half million inhabitants and an area of about 49,000 square kilometers (19,000 sq mi).

Animal species Number of Number of farms animals Cattle 482 421 13 889 Sheep 396 640 8 074 Goats 17 546 4 040 Pigs 475 996 1 388 Poultry 10 203 845 1 591 Horses 11 170 4 149 Ratites 479 308

Ministry of Agriculte and Rural Development of the SR State Veterinary and Food Administration of the SR District Veterinary and Food Administrations /40/ State Veterinary and Food Institutes Institute for State Control of Veterinary Biologicals and Medicaments (ISCVBM) Institute for Postgraduate Education of Veterinary Surgeons

, INSTITUTE FOR POSTGRADUATE EDUCATION OF VETERINARY SURGEONS AND INSTITUTE FOR STATE CONTROL OF VETERINARY BIOLOGICALS AND MEDICAMENTS IPEVS Košice ISCVBM Nitra

Act on Veterinary Care (No. 39/2007 Coll.) Implementing National and European Legal Acts Act on Medicinal Products and Medical Devices (No. 362/2011 Coll.) and guidelines, for example: Guidelines for the prudent use of antimicrobials in veterinary medicine

Common for veterinary and human medicinal products Assumption of coordinated approach in decreasing of consumption of antibiotics in veterinary and human medicine, mainly critically important ATB in animals and humans (e.g. fluoroquinolons, cephalosporines of the 3rd and 4th generation )

Organisation of veterinary supervision in veterinary pharmacy List of veterinary medical products, substances and veterinary devices authorisation of registration of veterinary medicals ISCVBM laboratory analysis ISCVBM authorisation, measurement control, sanctions - producers of veterinary medicinal products - whole distributors of veterinary medicinal products - producers of medicated feeds MARD SR management, guidance, coordination control, sanctions management, professional guidance control, measures, sanctions - producers of veterinary medicals - whole distributors of veterinary medicals SVFA SR Department of feed, ecology and veterinary pharmacy control management, guidance, coordination, control, planning, evaluation DVFA (40) control of expenditure/use - public pharmacies - farms private veterinarians - producers of veterinary medicals - whole disitributors of veterinary medicals - medicated feeds

ANIMALS PRODUCER / IMPORTER OF VETERINARY MEDICINAL PRODUCTS PRODUCER OF MEDICATED FEEDINGSTUFFS DISTRIBUTOR OTHER DISTRIBUTOR PHARMACY PRESCRIPTION OF VETERINARIAN MEDICATED FEEDINGSTUFF VETERINARIAN DELIVERY APPLICATION ANIMAL BREEDER DAILY RECORD ON USE

(1) Veterinarian shall be obliged to keep and maintain for the period of 5 years the record: a) date of animal treatment b) its breeder c) number and identification of treated animals, diagnosis, prescribed veterinary medicinal product

d) quantity of administered doses and on manner of their administration e) length of treatment and on specified withdrawal periods (2) Records* according to paragraph1in beekeeper may be kept by the inspector for bee health ( new wording Article104) *Book of veterinary treatments according to Ordinance of the Government of the SR No 504/2004 Coll.

Provision of Article 122 paragraph 15 was supplemented by the sentence Veterinary medicinal product for injection application may be administered only by the veterinarian. Based on the mentioned ammendment the veterinary medicinal product for injection application may be administered only by the veterinarian

(3) Breeder or the owner of the food producing animal is obliged to a) keep the records on veterinary medicinal products administerd to the food producing animal in the Breeders Register, according to the special regulation* b) every 6 months, provide concerned District Veterinary and Food Administration information in the written form on consumption of veterinary medicinal products in food producing animals, based on the data from the List of administered veterinary medicinal products, due to the special regulation Breeder s Register, information on consumption of veterinary medicinal products including mainly:

1. date of animal treatment 2. number and species of treated animals 3. name of concerned veterinary medicinal product 4. quantity of administered veterinary medicinal product 5. name and address of supplier of veterinary medicinal product c) On demand of the District Veterinary and Food Administration, sumbit evidence on purchase, keeping and administering of the veterinary medicinal products to the food producing animals. Animal treatment by VMP (veterinary medicinal product) can be performed by the owner only after instruction of the attending veterinarian excluding administering of injection application of VMP.

Official controls of veterinary medicinal products placing to the market and their use Official controls of the veterinary medicinal products are ensured at each level of the medicinal product chain: production distribution of veterinary medicinal products and storage expenditure of veterinary medicinal products in public pharmacies use of veterinary medicinal products in in the prevention and treatment of the diseases.

Frequency of the controls depends on: size of the farm, animal species use of veterinary medicinal products and risk analysis Based on the Methodological Instruction of SVFA SR in the area of veterinary pharmacy: each DVFA shall work out a Plan of Official Controls of veterinary medicinal products within their region and ISCVBM shall work out an annual plan of inspections including sampling, plan of the inspections in: o producers, o whole distributors and o producers of medicated feeds

Official controls in the area of veterinary pharmacy in 2015 DVFA ISCVBM TOTAL Number of official controls 4209 26 4235 In finding shortcomings (52) within each of the official control the measures for their removal were imposed to the concerned control authorities.

Official controls in the area of veterinary pharmacy in 2015 Competent Authority Number of controls Number of additional controls Number of found shortcomings Whole distribution of veterinary medical products DVFA 59 0 0 ISCVBM 7 1 8 Public pharmacies DVFA 233 8 14 Private vetrinarians DVFA 781 1 1 Breeders DVFA 2169 6 8 Producers of medicated feeds ISCVBM 1 0 4 Production of veterinary medical products ISCVBM 8 1 17 TOTAL 4235 17 52

Official controls in the area of veterinary pharmacy in the 1st half of the year 2016 Competent Authority Number of controls Number of additional controls Number of found shortcomings Whole distribution of veterinary medicinal products DVFA 17 1 1 ISCVBM 16 1 5 Public pharmacies DVFA 88 0 0 Private veterinarians DVFA 335 0 0 Breeders DVFA 991 1 1 Producers of medicated feeds ISCVBM 1 0 3 Producers of veterinary medicinal products ISCVBM 5 0 6 TOTAL 1456 3 16

Ban of use of ATB as the growth stimulators Application of ATB in animals only on the basis of diagnosis and further prescription by the veterinarian Restriction of use of critically important ATB for humans in animals (e.g. fluoroquinols, cephalosporins of 3rd and 4th generation)

Improvement of health status of the animals (protection of breedings biosecurity, prevention of diseases including application of effective vaccines, breeding conditions welfare, nutrition, etc.) Elimination of economic incentives facilitating irregular prescription of ATB

Define strategy of ATB use control programme in human and veterinary medicine (national platform of drug policy) Set the integration procedures among competent authorities in public health, veterinary and food sector in surveillance, AMR monitoring in certain zoonotic bacteria

Consumption of antimicrobial substances according to animal species Slovak Republic is involved in ESVAC collection of data on sale of VMP since 2011 Slovak Republic is involved in the Pilot Project collection of data on consumption of antimicrobial substances according to animal species In the Slovak Republic the results on the consumption of antimicrobial substances in 5 pig breedings were collected and summarized. Breedings were selected on the basis of criteria established by EMA - closed turnover of the herd - over 10 sows in the breedings

Consumption of antimicrobial substances according to animal species No. of farm Average number of animals in 2013 Average number of gilts calculated in feeding days Average number of sows/boars calculated in feeding days Average number of sucklings calculated in feeding days Average number of piglets in feeding days Average number of breeding pigs calculated in feeding days 1. 2533 93 224 467 971 778 2. 275 8 33 48 89 97 3. 637 24 61 115 194 243 4. 371 17 40 127 105 82 5. 448 14 62 228 83 61

Consumption of antimicrobial substances according to animal species Active substance Real consumption of active substance in kg - Amoxycilinum 2,94033 - Sulfadoxinum 0,0228 - Trimethoprimum 0,00456 - Doxycyclini hyclas 1,225 - Oxytetracyclinum 0,38879 - Enrofloxacinum 0,06198 - Lincomycinum 0,54823 - Spektinomycinum 1,056082 - Marbofloxacinum 0,000704 - Procaini benzylpenicillinum 0,323976 monohydricum - Benzathini benzylpenicillinum 0,242982 - Tylosinum, Tylosini tartas 0,022907 - Tiamulini fumaras 1,80374 - Tiamulini hydrogenofumaras - Florfenicolum 0,0021 - Tetracyclini hydrochloridum 15,2424 Total in kg: 23,886581

Consumption of antimicrobial substances according to animal species 16 14 12 10 8 6 4 2 0 Real consumption of active substances in kg for 2013 from 5 - pig farms

Consumption of antimicrobial substances based on data of imports in 2011, 2012 and based on data of sales in 2013 in tons Year 2011 2012 2013 Antibiotics 0,0108978 0,0120966 0,0109988 Sulfoamids 0,32761736 0,076788 1,65701063 Tetracyclines 2,08921 2,3200843 4,79219965 Amfenicoles 0,091695 0,132855 0,150552 Wide spectrum Penicillins 4,089392163 2,8776808 1,901380375 Lactamase sensitive Penicillins 0,461834295 0,8427211 0,419463764 Beta-lactamase resistant Penicillines 0,1209068 0,1391478 0,15048104 1st gereration Cephalosporines 0,1077916 0,1037246 0,123610188 3rd generation Cephalosporines 0,133785464 0,2025823 0,090419 4th generation Cephalosporines 0,027842325 0,0083348 0,007765325 Trimetoprim and derivates 0,0650806 0,3032383 0,162638878 Macrolides 0,18479877 0,1950964 1,39162367 Lincosamines 0,03532048 0,1459376 0,08369054 Streptomycines 0,706023264 0,6779852 0,907069192 Other aminoglycosides 0,036578812 0,0310939 0,079915592 Fluorochinolons 0,74744085 0,8483348 0,708880025 Other chinolons 0,0815 0 0,030013 Polymyxines 0,3077778 0,426212 0,2830478 Imidazol derivates 0,011905 0 0 Pleuromutilines 1,30414 1,056 2,31106645 Other antibacterial substances 0,049418068 0 0,568784881 Total: 10,99095645 10,3999135 15,8306108

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