Agro-Veterinary Shop Permit Guidelines - Guidance on Procedures for Applying for Permit and Operating an Agro-Veterinary Shop, 2017

Zambia Medicines Regulatory Authority AGRO VETERINARY SHOP PERMIT GUIDELINES GUIDANCE ON PROCEDURES FOR APPLYING FOR PERMIT AND OPERATING AN AGRO-VETERINARY SHOP Approved by the ZAMRA Board 20th December 2017 Date of implementation January 2018 These guidelines on Agro Veterinary shops are issued by the Zambia Medicines Regulatory Authority pursuant to section 68 of the Medicines and Allied Substances Act, 2013 of the laws of Zambia. The Authority may amend any part of these guidelines from time to time. CONTENTS GLOSSARY ........................................................................................................................ i 1.0 INTRODUCTION ....................................................................................................... 1 2.0 APPLICATION PROCEDURE FOR ISSUANCE OF AN AGRO-VETERINARY SHOP PERMIT ... 1 3.0 SUBMISSION OF THE APPLICATION ........................................................................... 2 4.0 PERSONNEL REQUIREMENTS FOR AN AGRO-VETERINARY SHOP ................................. 2 5.0 STANDARDS FOR AGRO-VETERINARY SHOP PREMISES ............................................... 3 5.1. Premises of an Agro-Veterinary Shop ................................................................ 3 5.2. Safety of Premises ........................................................................................... 4 5.3. Security of Premises ........................................................................................ 4 5.4. Conditions of Premises, Design and Materials .................................................... 4 6.0 SUPPLY OF PRESCRIPTION ONLY VETERINARY MEDICINES ......................................... 5 7.0 ROLES AND RESPONSIBILITIES IN AN AGRO-VETERINARY SHOP ................................ 6 7.1. Agro-Veterinary Shop Owner ............................................................................ 6 7.2. Responsible Person ......................................................................................... 7 7.3 Supervising Veterinary Surgeon…………………………………………………………………......7 8.0 HYGIENE WITHIN THE PREMISES .............................................................................. 8 9.0 RECORD KEEPING FACILITIES ................................................................................... 8 10.0 STORAGE OF MEDICINES .......................................................................................... 9 11.0 DISPOSAL OF WASTE ............................................................................................... 9 11.1. Disposal of Non-pharmaceutical waste .............................................................. 9 11.2. Disposal of unwanted medicines and allied substances (obsolete and expired).....10 12.0 RECALL OF MEDICINES ............................................................................................11 13.0 REFERENCE MATERIALS ..........................................................................................11 14.0 CONTACT DETAILS ..................................................................................................12 Annexure I: List of requirements for Agro-Veterinary Shops premises ...........................13 i Interpretations In these Guidelines, unless the context otherwise requires Act means the Medicines and Allied Substances Act, 2013 (No.3 of 2013); Agro veterinary shop means agro veterinary shop class I, class II and class III as provided by statutory instrument (No.10) of 2016; Authority means Zambia Medicines Regulatory Authority Authorised prescriber means a veterinary surgeon or such other person as the Minister may, on the advice of the Authority, by statutory instrument, designate; Dispense or dispensing means the interpretation of a valid prescription or order of an authorised prescriber; by a responsible person; Permit means an Agro veterinary shop permit issued under section twenty nine of the Act; Pharmaceutical Licence means the licence issued, under section thirty four of the Act to a person to manufacture, distribute or deal in a medicine or allied substance; Prescription means a written direction given by an authorized prescriber directing that a stated amount of a medicine specified in the direction be dispensed for the animal named in the direction; Prescription only veterinary medicine means a veterinary medicine dispensed only on prescription; Responsible person means a person who has the control and management of an agro-veterinary shop; Shop means an agro-veterinary shop; Suitably qualified person means a person certified by the Veterinary Council of Zambia to carry out duties in an agro-veterinary shop class III. Supervising veterinary paraprofessional means a veterinary paraprofessional providing supervisory services to an agro-veterinary shop class III; Supervising veterinary surgeon means a veterinary surgeon providing supervisory services to an agro-veterinary shop; Veterinary Assistant a person registered as a veterinary para professional under the Veterinary and Veterinary Para-Professions Act, 2010 (No. 45 of 2010). ii Veterinary Surgeon means a surgeon registered in accordance with the Veterinary and Veterinary Para- Professions Act, 2010 (No.45 of 2010). 1 1.0 INTRODUCTION The Zambia Medicines Regulatory Authority (ZAMRA) is a regulatory body established under Medicines and Allied Substances Act No. 3 of 2013 of the Laws of Zambia. Among other things, ZAMRA is mandated to regulate and register Agro veterinary shops. Pursuant to Section 30 (2) of the Act, the guidelines are hereby established to provide guidance to a person intending to operate an Agro-veterinary shop. 2.0 APPLICATION PROCEDURE FOR ISSUANCE OF AN AGRO VETERINARY SHOP PERMIT 2.1. A person who intends to operate an agro-veterinary shop shall apply to the Authority for a permit as provided under Statutory Instrument (No. 10) of 2016, provided that: (a) The application is duly completed in a prescribed manner and form; (b) The prescribed fee is paid in full (c) The person is a holder of a valid Business Levy/ permit issued by the local Authority; (d) The person is a holder of a valid Certificate of Incorporation/Business Name Registration Certificate/Certificate of Registration of a co-operative. 2.2. Attachments to the application for an Agro-Veterinary Permit An application made in accordance with 2.0 above shall be accompanied by: (a) A valid professional practicing certificate for the responsible person, as applicable; and (b) Sketch of the floor plan for the premises. 2 3.0 SUBMISSION OF THE APPLICATION 3.1. A completed application shall be submitted to the nearest ZAMRA Office or its authorised agent. 4.0 PERSONNEL REQUIREMENTS FOR AN AGRO-VETERINARY SHOP 4.1. An Agro-veterinary shop class I shall be under the management of a Veterinary Surgeon. Class I shall deal in products listed in Part A of the Second Schedule of SI (No.10) of 2016; 4.2. An Agro-veterinary shop class II shall be under the management of a Veterinary Assistant but being supervised by a Veterinary Surgeon. Class II shall deal in products listed in Part B of the Second Schedule of SI (No.10) of 2016; 4.3. An Agro-veterinary shop class III shall be under the management of suitably qualified person but being supervised by a Veterinary Paraprofessional. An agro-veterinary shop class III shall deal with products listed in Part C of the Second Schedule of SI (No.10) of 2016. 4.4. A Veterinary Surgeon shall provide supervision for a minimum of two (2) visits per month at each class II Agro-veterinary shop; 4.5. A Veterinary paraprofessional shall provide supervision for a minimum of two (2) visits per month at each class II Agro-veterinary shop; 4.6. An Agro-veterinary shop shall be required to maintain a log book for the supervising Veterinary Surgeon or Paraprofessional; 4.7. Supervising Veterinary Surgeon or Paraprofessional shall be required to indicate activities performed in the log book which shall be subject to inspection by the Authority’s inspectors; 4.8. Failure by the supervising Veterinary Surgeon or Paraprofessional to indicate activities performed in the log book and meet the minimum number of hours required for supervision of an Agro-veterinary shop, shall be construed as professional misconduct. 3 5.0 STANDARDS FOR AGRO-VETERINARY SHOP PREMISES 5.1. Premises of an Agro-Veterinary Shop 5.1.1. The external appearance of an Agro-veterinary shop premises must be clean. 5.1.2. The premises should be identified distinctly by a sign post with following details: (a) name of Agro-veterinary shop; (b) address of Agro-veterinary shop; (c) telephone/contact number; (d) operating times on door or window; and (e) standard logo for an Agro-veterinary shop: The logo shall be obtained from ZAMRA. 5.1.3 The design and layout of an Agro-veterinary shop must permit a logical flow of work, effective communication and supervision and ensure effective cleaning and maintenance and must minimize the risk of errors, cross-contamination and anything else which would have an adverse effect on the quality of products; 5.1.4 All parts of the premises must be maintained in an orderly and tidy manner; and 5.1.5 Regardless of the class of an Agro-veterinary shop, a valid annual practicing certificate for the responsible person should be displayed conspicuously in an Agro-veterinary shop. 4 5.2. Safety of Premises 5.2.4. Working environment must be arranged in a manner that ensures the safety of the public and people working on the premises and comply with relevant legislation relating to safety in the workplace; 5.2.5. Measures to prevent accidents and fires must be put in place; 5.2.6. Staff must be familiar with the fire prevention procedures; and 5.2.7. Equipment must be maintained in good working order. 5.3. Security of Premises 5.3.4. Careful consideration must be given to the overall security of an Agro-veterinary shop. 5.3.5. The shop must be lockable and as far as possible exclude any unauthorised entry. 5.3.6. Security measures must be in place to provide for the safety of both staff and medicines. 5.3.7. Depending on the design of the premises, burglar bars/security doors or any other such installations should be installed on all entrance/exit doors and windows. 5.3.8. Where practicable, it is advisable that security guard(s) are engaged, and other security systems installed such as closed circuit television. The engagement of security guard(s) in a class 1 agro-veterinary shop shall be mandatory. 5.4. Conditions of Premises, Design and Materials 5.4.4. The floors, walls, windows, ceiling, woodwork and all other parts of the premises must: (a) Be made of durable and easy to clean materials; (b) Be kept in a continuous good order, repair and condition for the purposes of prevention of infestations, and adding beauty to the premises; 5 5.4.5. Countertops, shelves, floors and walls must be with a smooth finish, washable, and easy to clean material for the purposes of maintaining hygienic conditions; 5.4.6. The premises should have adequate natural and/or artificial ventilation; 5.4.7. The premises should have sufficient natural and/or artificial lighting, and the walls, floors and ceiling are in a good state of repair; 5.4.8. The premises should have a leak-proof roof; 5.4.9. The premises should have clearly partitioned areas for carrying out specific activities such as main shop, area for supplying prescription only veterinary medicines, and expired medicines area; 5.4.10. The premises should have adequate sanitation facilities such as toilets and hand-washing utility; and 5.4.11. The premises must have sufficient shelving which are smooth, washable and impermeable; 6.0 SUPPLY OF PRESCRIPTION ONLY VETERINARY MEDICINES 6.2.1. The prescription only veterinary medicine shall be sold or supplied upon receipt of a prescription issued by an authorized prescriber; 6.2.2. A prescription shall be in writing, signed and dated by the authorized prescriber issuing it, with registration number of the prescriber; 6.2.3. The prescription shall specify: (a) The name and strength of the medicine; (b) the amount of the medicine to be supplied; (c) the dose to be taken; (d) the duration of treatment; (e) Species of animal(s) to be treated (f) the route of administration (g) Signature of the prescriber and 6 (h) Prescriber’s stamp 6.2.4. Upon supply of any prescription only medicine, the responsible person shall record the prescription in a prescription register maintained for that purpose. If it is not reasonably practicable, the prescription should be recorded not later than the next business day. 6.2.5. An entry made in the prescription register shall indicate the: (a) serial number of the entry; (b) date of supply; (c) name and registration number of the authorized prescriber; (d) name of the medicine or preparation and the quantities thereof; (e) name of the manufacturer of the medicinal product, its batch number and the expiry date; and (f) The signature of the suitably qualified person or responsible person. 6.2.6. A prescription shall not be dispensed for the first time later than twenty eight days after the date of issue. 7.0 ROLES AND RESPONSIBILITIES IN AN AGRO-VETERINARY SHOP 7.1. Agro-veterinary shop owner 7.1.4. The shop owner shall ensure that: (a) The shop permit is displayed in the shop at all times; (b) The shop permit is renewed before the expiring date; (c) The shop is managed by an suitably qualified person; (d) There is no interference to the work being done by an suitably qualified person; (e) Storage and sale of medicines is in according with the requirement of the law; (f) Medicines being sold in an agro-veterinary shop are not unauthorized, expired, sub-standard or falsified; and (g) Reference books and other documents for record keeping are available all the time; 7 7.2. Responsible Person 7.2.4. The responsible person shall: (a) Be responsible for the medicines in the shop; (b) Ensure that the shop is kept clean at all times; (c) Provide health education to the public (owners of animals) in relation to the proper use of medicines; (d) Ensure that all medicinal products are authorized for supply and are sourced from authorized suppliers; (e) Handle all the technical duties related to medicine dispensing in the shop; (f) Be certain that the shop is properly registered and operating in accordance with the law; (g) Ensure that any returned, unwanted, expired, substandard and falsified product is appropriately segregated and located in a designated secure area; and (h) Keep in proper form all required records relating to the purchase and supplying of medicines. 7.3. Supervising Veterinary Surgeon or Paraprofessional 7.3.4. The supervising Veterinary Surgeon when providing services to the shop shall: (a) Attend for reasonable, regular and ongoing periods of the operating time of the shop at the professional services area of the practice, in order to properly carry out the role of supervising: (b) Ensure that clear, structured procedures are in place and consistently operated within the shop, with regard to the management of the dispensing activity, including quality assured safety checking systems and the maintenance of records; 8 (c) Ensure that all personnel operating within the shop under their charge are aware of the scope of their role and the limits applicable in respect of the management of the professional services provided; (d) Ensure that the appropriate business registration documents and proof of affiliation to relevant professional bodies are conspicuously displayed; (e) Provide guidance on the storage of drugs, sale and supplying of medicines; (f) Ensure that the responsible person is managing the Agro vet shop as per the guidelines. (g) Supervise the shop for at least two visits per month and shall indicate the activities performed in the log book; 8.0 HYGIENE WITHIN THE PREMISES 8.1. There must be a suitable, clean hand wash basin made of a smooth, washable and impermeable material which is easy to maintain. 8.2. There must be toilet facilities suitable for use by both genders. 8.3. Toilet facilities must be kept clean, tidy and must not be used for storage of medicines. 8.4. Hand-washing facilities must be provided in the toilet area with a conspicuous notice requesting users to wash their hands after using the facility. Facilities must include readily available antiseptic/medicated soap. 8.5. In a case where toilet facilities are communal, attempts should be made to ensure that the above measures are adhered to. 9.0 RECORD KEEPING FACILITIES 9.1. Every agro-veterinary shop shall be required to keep correct records with regard to medicines and allied substances and these shall include: (a) Invoices and receipts; (b) Proforma invoice/Quotation where applicable 9 (c) Daily cash sales book; (d) Prescription Register; (e) Expired Product Register; (f) Prescription file; (g) Stock records; (h) Recalled products register; and (i) Computer (where applicable). 9.2. The documents referred to in (9.1) above shall be kept for at least 2 years and be required to be made available for inspection if need be by the Authority’s inspectors; 10.0 STORAGE OF MEDICINES 10.1. The storage of veterinary medicines in an agro veterinary shop shall be in the manufacturer’s original container and under conditions stipulated by the manufacturer. The medicines shall be stored within the stipulated temperatures. 10.2. Veterinary medicines shall be kept away from direct sunlight, moisture or water. 10.3. An updated inventory control system shall be maintained for every veterinary medicine or product kept in the Agro veterinary shop. 10.4. Where veterinary medicines are transferred to another container which should be appropriately labelled, care shall be taken to protect the integrity of the product and prevent contamination of the medicines; 10.5. The Authority shall where it is established that the holder of a permit stocks veterinary medicines or products under unsanitary conditions, direct the holder to dispose of the veterinary medicines or products at the holders cost. 11.0 DISPOSAL OF WASTE 11.1. Disposal of non-pharmaceutical waste 10 (a) A suitable and adequate means of waste disposal must be available and in use. (b) Waste materials must not be allowed to accumulate in large quantities and must be collected in suitably covered (as applicable) receptacles for removal to collection points. (c) Under no circumstances must substances be disposed of down surface water drains, e.g. storm water drainages. 11.2. Disposal of unwanted medicines and allied substances (obsolete and expired) (a) An agro-veterinary shop shall withdraw and store all obsolete, expired and unwanted medicines and allied substances separately from usable stock and in packages or cartons clearly labelled “obsolete”, or “expired medicines” or “unwanted products”; (b) Medicines and allied substances that are not fit for animal use shall not be dispensed in an agro-veterinary shop; (c) An agro-veterinary shop shall communicate to the Authority so that obsolete, expired and unwanted medicines and allied substances are disposed off according to the guidelines on disposal of unwanted/expired/obsolete pharmaceutical products; and (d) The cost and responsibility to dispose of obsolete, expired and unwanted medicines and allied substances shall be borne by an agro-veterinary shop. 11 12.0 RECALL OF MEDICINES 12.1. Where medicines and allied substances which have been recalled or withdrawn and have to be removed from the market due to problems with quality, safety, or efficacy as per guidelines on recall/withdrawal of medicines, an agro-veterinary shop shall co-operate with the Authority to facilitate the recall of such medicines. 13.0 REFERENCE MATERIALS 13.1. To facilitate daily operations, every agro-veterinary shop shall have reference materials shall have at the minimum the following; (a) Statutes (i) Medicines and Allied Substances Act No.3 of 2013; (ii) Dangerous Drugs Act, Chapter 95 for Class I (iii) Narcotic Drugs and Psychotropic Substances Act, Chapter 96 for Class I (iv) Animal Health Act (No.27) of 2010 (v) Veterinary and Para–Veterinary Professions Act (No. 45) of 2010 (vi) Statutory Instrument No. 10 of 2016 (Agro-Veterinary Regulations) (b) Other reference materials (i) Guidelines on Agro-veterinary shops (ii) List of Authorized prescribers (iii) List of registered veterinary surgeons and para-veterinary professionals. (iv) Register of medicines with Marketing Authorisation (v) Register of Pharmaceutical Licence Holders. (vi) Zambia National Veterinary Formulary (ZNVF) – preferably recent edition Note: Electronic access to the required references may be acceptable. 12 14.0 CONTACT DETAILS The Director General Zambia Medicines Regulatory Authority P. O. Box 31890 Plot No. 6903, Tuleteka Road, Off Makishi Road LUSAKA Telephone: +260-211-220439 E-mail: pharmacy@zamra.co.zm 13 Annex I: List of requirements for Agro-Veterinary Shops premises Agro-veterinary Shops Class I (i) Premises a) Conspicuous signage for identity b) Clean and tidy surroundings c) External and internal walls should be smooth and kept clean (painted or tiled) d) Good security which may include burglar bars on both doors and windows. e) Smooth and impervious floor which is easy to disinfect and clean f) Adequate natural and artificial ventilation g) Adequate natural and artificial lighting (ii) Relative Partitioning a) Front shop/sales b) Storage area for prescription only veterinary medicines c) Main warehouse or storeroom with air conditioning d) Recalled products room with adequate space under lock and key e) Expired products room with adequate space under lock and key f) Access to water closet toilet(s) with hand washing basin g) Office space (iii) Facilities and Equipment a) Adequate shelves and pallets b) Pedal waste bin(s) c) Cold storage facility e. g, Refrigerator, Freezer, or Liquid Nitrogen tank. d) Fire extinguishers placed at strategic positions e) Air conditioners for medicines storage areas f) Access to alternative source of electricity g) Secure Cupboard, Receptacle or Dedicated Room for Dangerous Drugs (iv) Documentation / Record Keeping Facilities a) Prescriptions Register b) File for prescriptions c) Dangerous Drugs Register d) Bin cards (stock cards) e) Computer or equivalent device f) Expired products register g) Recalled products register 14 h) Receipts i) Internal issue books j) Sales and Purchase Invoices (where applicable) k) Delivery notes (where applicable) (v) Stock Surveillance Facilities a) Temperature monitoring (i) Temperature charts (ii) Wall and cold storage facility thermometers or data loggers b) Standard operating procedures (SOPs) for: (i) Handling of expired products, (ii) Handling of recalled products (iii) Supply of products 15 Agro-veterinary Shops Class II (i) Premises a) Conspicuous signage for identity b) Clean and tidy surroundings c) External and internal walls should be smooth and kept clean (painted or tiled) d) Good security which may include burglar bars on both doors and windows e) Smooth and impervious floor which is easy to disinfect and clean f) Adequate natural and artificial ventilation g) Adequate natural and artificial lighting (ii) Relative Partitioning a) Front shop/sales b) Storage area for prescription only veterinary medicines c) Main warehouse or storeroom with air conditioning facilities d) Secure and adequate storage area for recalled products e) Secure and adequate storage area for expired products f) Access to water closet toilet(s) with hand washing basin g) Office space (iii) Facilities and Equipment a) Adequate shelves and pallets b) Pedal waste bin(s) c) Cold storage facility e.g., Refrigerator, Freezer, or Liquid Nitrogen tank. d) Fire extinguishers placed at strategic positions e) Access to alternative source of electricity (iv) Documentation / Record Keeping Facilities a) Prescriptions Register b) File for prescriptions c) Bin cards (stock cards) d) Computer or equivalent device e) Expired products register f) Recalled products register g) Receipts h) Internal issue books i) Sales and Purchase Invoices (where applicable) j) Delivery notes (where applicable) 16 (v) Stock Surveillance Facilities a) Temperature monitoring (i) Temperature charts (ii) Wall and cold storage facility thermometers or data loggers b) Standard operating procedures (SOPs) for: (i) Handling of expired products, (ii) Handling of recalled products (iii) Supply of products (iv) Cleaning on premises. 17 Agro-veterinary Shops Class III (i) Premises a) Conspicuous signage for identity b) Clean and tidy surroundings c) External and internal walls should be smooth and clean (painted and tiled) d) Good security which may include burglar bars on both doors and windows e) Adequate security f) Smooth floor which is easy to disinfect and clean g) Adequate natural and artificial ventilation h) Adequate natural and artificial lighting (ii) Relative Partitioning a) Front shop/sales b) Storage area for prescription only veterinary medicines c) Secure and adequate storage area for recalled products and expired products d) Access to toilet (s) with hand washing facility (iii) Facilities and Equipment a) Adequate shelves and pallets b) Pedal waste bin(s) c) Refrigerator (Optional, only those stocking New Castle Disease Vaccine) (iv) Documentation / Record Keeping Facilities a) Prescriptions Register b) File for prescriptions c) Stock control book d) Computer or equivalent device (where affordable) e) Expired products register f) Recalled products register g) Receipts h) Internal issue books i) Sales and Purchase Invoices (where applicable) j) Delivery notes (where applicable) (v) Stock Surveillance Facilities a) Temperature monitoring (i) Temperature charts (ii) Wall thermometers 18 b) Standard operating procedures (SOPs) for expired, recalled products and distribution. (i) Handling of expired products, (ii) Handling of recalled products (iii) Supply of products (iv) Cleaning on premises. 19 ANNEX II: LIST OF VETERINARY PRODUCTS TO BE STOCKED IN AGRO VETERINARY SHOPS A. List of veterinary medicines and allied substances for Agro Veterinary Shops Class I 1. All Prescription-only veterinary Medicine (POM-V) with marketing authorization; 2. All Pharmacy (P-V) veterinary medicines with market authorization; 3. All General sales (GS) veterinary medicines and allied substances; 4. All medicines that have been imported or manufactured with special authorization. 5. Medicines and allied substances added via ZAMRA prescribed guidelines on the recommendation of the Ministry responsible for Veterinary Services in response to changing disease epidemiological status or disease outbreaks. 20 B. List of veterinary medicines and allied substances for Agro Veterinary Shops Class II Part A Item Dosage forms Analgesics- Non-steroidal Anti inflammatories 1. Acetaminophen Tablets or powder 2. Carprofen Tablets 3. Diclofenac Tablets or gel 4. Dimethyl Sulfoxide (DMSO) Tablets, or cream or ointment 5. Dipyrone Injection 6. Flunixin Meglumine Injection 7. Ketoprofen Tablets or powder 8. Meloxicam Tablets or powder Antiprotozoa 1. Amprolium Injectable solutions 2. Amprolium Soluble powders 3. Parvaquone Injectable solutions 4. Burparvaquone Injectable solutions 5. Diminazene aceturate Injectable solutions 6. Diminazene aceturate Injectable soluble granules 7. Imidocarb Dipropionate Injectable solutions 8. Isometamidium chloride Injectable soluble powder 9. Parvarquone Injectable solutions 10. Quinapyramine Sulphate/Chloride Antifungals 1. Fluconazole Tablets or powder 2. Griseofulvin Tablets or capsules 3. Ketoconazole Tablets, capsules, lotions or shampoo Antihistamines 1. Chlorpheniramine Tablets 2. Cimetidine Tablets 3. Diphenhydramine Tablets 4. Cetirazine Tablets 21 Antimicrobials 1. Amikacin Tablets 2. Amoxicillin Tablets, capsules or injection 3. Ampicillin Tablets, capsules or injection 4. Doxycycline Tablets, capsules or injection 5. Neomycin Pessaries, ointment or creams 6. Oxytetracycline injectable solutions All concentrations and dosage forms 7. Oxytetracycline soluble powder All concentrations and dosage forms 8. Oxytetracycline soluble powder with vitamins All concentrations and dosage forms 9. Penicillin Injection 10. Penicillin-streptomycin Injection 11. Sulfadimidine Injectable solutions 33%w/v, 33.3% 12. Sulfadimidine Powder 13. Tetracycline Ointment or spray 14. Tetracycline Powder 15. Tiamulin Powder Autonomic Drugs 1. Atropine Injection 2. Bethanechol Injection 3. Glycopyrrolate Injection Electrolytes/Nutritional 1. Calcium Injection and powder 2. Iron Injection or oral liquid 3. Methionine, D-L Powder 4. Multivitamin Injectable solution 5. Multivitamin Soluble powder 6. Potassium Injection 7. Selenium/Vitamin E Injection 8. Taurine Injection 9. Vitamin A & D Injection 10. Vitamin B complex Injection 11. Vitamin C Tablets or powder 12. Vitamin D Injection 13. Vitamin K Injection 14. Sodium Chloride 0.9% (N-Saline) Solution 15. Dextrose 5%, 50% Solution 22 16. Ringers Lactate Solution Gastrointestinal Agents 1. Metoclopramide Tablets 2. Sucralfate Tablets Hormones 1. Dexamethasone Injection 2. Dinoprost Injection 3. Estradiol cypionate Injection 4. Gonadorelin Injection 5. Oxytocin Injection 6. Progesterone Injection 7. Stilboestral dipropionate Injection 8. Triamcinolone Injection Respiratory 1. Aminophyline Tablet or injection 2. Dextromethorphan Injection 3. Doxapram Injection Sedatives 1. Acepromazine Tablet Miscellaneous 1. Methimazole Tablet 2. Propylene glycol Liquid 3. Protamine sulfate Powder Allied substances (Acaricides) 1. Chlorfenvinphos Concentrate 2. Dichlorvos Concentrate Anthelmintics 1. Albendazole Bolus up to 2.5g 2. Albendazole Suspensions 2.5%w/v,10%w/v 3. Clorsulon Injection 4. Closantel Injection or drench 5. Febantel Drench, bolus or injection 6. Fenbendazole Drench, bolus or injection 7. Haloxon Drench 23 8. Hexachloroethane Drench 9. Hexachloroparaxylene Drench 10. Hexachlorophene Drench 11. Ivermectin Bolus or powder 12. Ivermectin Injectable solutions 13. Levamisole Bolus or powder 14. Levamisole hydrochloride Drench, powder or injection 15. Levamisole phosphate injection Injection 16. Mebendazole Drench, tablets, bolus 17. Niclosamide Drench or bolus 18. Nitoxynil Drench or bolus 19. Oxfendazole Drench or bolus 20. Oxibendazole Drench or bolus 21. Oxyclozanide Drench or bolus 22. Oxyclozanide Drench or bolus 23. Parbendazole Drench or bolus 24. Piperazine citrate Soluble powders 25. Piperazine citrate Tablets 26. Praziquantel Tablets 27. Pyrantel Tablets or oral liquid 28. Rafoxanide Drench or bolus 29. Tetramisole Drench or bolus 30. Thiabendazole Drench or bolus 31. Thiophanate Drench or bolus 32. Trichlorfon Drench or bolus 33. Triclabendazole Drench or bolus 34. Ivermectin/Clorsulon Injection 35. Levamisole/Oxyclozanide Drench or bolus 36. Piperazine citrate/pyrantel parmoate Tablets or oral liquid 37. Levamisole/piperazine dihydrochloride Powder Biologicals: Poultry vaccines 1. Anticoccidial Vaccines All dosage forms 2. Chicken Anaemia virus Vaccines All dosage forms 3. Fowl cholera Vaccines All dosage forms 4. Fowl Pox Vaccines All dosage forms 5. Fowl typhoid Vaccines All dosage forms 6. Infectious Bronchitis Vaccines All dosage forms 24 7. Infectious bronchitis/Newcastle disease/egg drop syndrome Vaccines All dosage forms 8. Infectious bronchitis/Newcastle Inactivated vaccines All dosage forms 9. Infectious Bursal Disease Vaccines All dosage forms 10. Infectious Coryza Vaccines All dosage forms 11. Infectious laryngotracheitis Vaccines All dosage forms 12. Newcastle Cloned Vaccines All dosage forms 13. Newcastle disease Live vaccines All dosage forms 14. Newcastle disease Inactivated vaccines All dosage forms 15. Newcastle disease Thermostable vaccines All dosage forms 16. Salmonella vaccines for all avian All dosage forms 17. Egg drop syndrome vaccine All dosage forms Ruminant vaccines 1. Anaplasmosis Vaccines All dosage forms 2. Anthrax Vaccines All dosage forms 3. Avian & Bovine tuberculin kit Injectable 4. Black leg -Clostridium chauvoei Vaccines All dosage forms 5. Blackleg/Anthrax Vaccines All dosage forms 6. Blue tongue Vaccines All dosage forms 7. Botulism Vaccines All dosage forms 8. Botulism/Anthrax Vaccines All dosage forms 9. Anthrax/black quarter/botulism Vaccines All dosage forms 10. Bovine Ephemeral fever Vaccines All dosage forms 11. Brucella Vaccines All dosage forms 12. Calf paratyphoid Live and killed vaccine All dosage forms 13. Enzootic abortion Vaccines All dosage forms 14. Clostridial/Pasteurella Vaccines All dosage forms 15. Infectious bovine rhinotracheitis/parainfluenza/ bovine respiratory syncitial virus/bovine viral diarrhoea (combination) Vaccines, both live and killed All dosage forms 16. Leptospirosis Vaccines All dosage forms 17. Lumpy skin disease Vaccines All dosage forms 18. Milk ring test Antigen All dosage forms 25 19. Multiclostridials Vaccines All dosage forms 20. Pasturella Vaccines All dosage forms 21. Pulpy kidney Vaccines All dosage forms 22. Rift valley fever Vaccines, live and inactivated All dosage forms 23. Rota/Corona/E.coli Vaccine for cattle All dosage forms 24. Rift Valley Fever Inactivated vaccine for cattle All dosage forms 25. Rift Valley Fever Live vaccine for sheep All dosage forms 26. Bovine Rota/Coronavirus Vaccine/ Clostridium Perfringens Type C/Escherichia Coli Bacterin/Toxoid All dosage forms 27. Sheep multiclostridial Vaccines All dosage forms 28. Tetanus Vaccines All dosage forms 29. Tetanus Toxoid All dosage forms 30. Bovine Ephemeral Fever Vaccines All dosage forms 31. Vibriosis Vaccines All dosage forms Pig vaccines 1. Parvovirus Killed Vaccine/Erysipelothrix /Leptospira Bacterin Vaccine/toxoid All dosage forms 2. Boar-taint vaccine All dosage forms 3. E. coli/Clostridium Perfringens type C beta toxoid All dosage forms Vaccines for companion animals 1. Equine Influenza virus Vaccines All dosage forms 2. feline viral rhinotracheitis/feline calicivirus/feline panleukopenia Vaccines All dosage forms 3. Canine Parvovirus Vaccines All dosage forms 4. Horse Sickness Polyvalent vaccine All dosage forms 5. Canine Distemper/Adenovirus Type 2/Parainfluenza/Parvovirus modified live virus vaccine/Leptospira Bacterin Vaccine/toxoid All dosage forms Intra-uterine infusion drugs 1. Intrauterine pessaries Pessaries 26 Intrammamary infusion drugs 1. Mastitis intramammary infusion Ointments Ophthalmologic drug 1. Cloxacillin Eye Ointment 16.7% w/w Ointments 2. Dexamethasone ointment or drops Ointments or drops 3. Doxycycline Eye powder 4. Neomycin Ointment or drops 5. Oxytetracycline Powder or ointment Antiseptics 1. Povidone Iodine Concentrate Part B 1. All General sales (GSV) veterinary medicines and allied substances 2. Medicines and allied substances added via ZAMRA prescribed guidelines on the recommendation of the Ministry responsible for Veterinary Services in response to changing disease epidemiological status or disease outbreaks 27 C. List of veterinary medicines and allied substances for agro-veterinary shops Class III Part A Item Dosage forms Analgesics- Non-steroidal Anti inflammatories 1. Diclofenac Tablets or gel 2. Dipyrone Injection Antiprotozoa 1. Amprolium Soluble powders 2. Diminazene aceturate Injectable solutions Antihistamines 1. Chlorpheniramine Tablets Antimicrobials 1. Oxytetracycline injectable solutions All concentrations and dosage forms 2. Oxytetracycline soluble powder All concentrations and dosage forms 3. Oxytetracycline soluble powder with vitamins All concentrations and dosage forms 4. Tetracycline Ointment or spray 5. Tetracycline Powder Electrolytes/Nutritional 1. Multivitamin Soluble powder 2. Potassium Injection 3. Vitamin C Tablets or powder Allied substances (Acaricides) 1. Chlorfenvinphos Concentrate Anthelmintics 1. Albendazole Bolus up to 2.5g 2. Albendazole Suspensions 2.5%w/v,10%w/v 3. Closantel Injection or drench 4. Ivermectin Bolus or powder 5. Levamisole Bolus or powder 6. Oxfendazole Drench or bolus 28 7. Oxyclozanide Drench or bolus 8. Parbendazole Drench or bolus 9. Piperazine citrate Soluble powders 10. Piperazine citrate Tablets 11. Praziquantel Tablets 12. Pyrantel Tablets or oral liquid Biologicals: Poultry vaccines 1. Newcastle disease Thermostable vaccines Ophthalmologic drug 1. Cloxacillin Eye Ointment 16.7% w/w Ointments 2. Doxycycline Eye powder 3. Neomycin Ointment or drops 4. Oxytetracycline Powder or ointment Part B 1. All General sales (GSV) veterinary medicines and allied substances 2. Medicines and allied substances added via ZAMRA prescribed guidelines, and are categorised for distribution in Class 3 agro-veterinary shops, on the recommendation of the Ministry responsible for Veterinary Services in response to changing disease epidemiological status or disease outbreaks Note: All medicines with marketing authorisation for use in humans, if prescribed for use in animals, will only be accessed from registered pharmacies, on prescription from a registered veterinary surgeon.