Medicines and Allied Substances (Agro-Veterinary Shops) Regulations, 2016 (S.I. No. 10 of 2016)

GOVERNMENT OF ZAMBIA STATUTORY INSTRUMENT NO. 10 OF 2016 The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) The Medicines and Allied Substances (Agro-Veterinary Shops) Regulations, 2016 ARRANGEMENT OF REGULATIONS PART I PRELIMINARY Regulation 1. Title 2. Interpretation PART II AGRO-VETERINARY SHOP PERMIT 3. Application for permit 4. Request for information 5. Rejection of application for permit 6. Issuance of permit 7. Application for renewal of permit 8. Transfer of permit 9. Amendment of permit 10. Application for duplicate permit 11. Suspension of permit 12. Revocation of permit 13. Location of agro-veterinary shop Copies of this Statutory Instrument can be obtained from the Government Printer, P.O. Box 30136, 10101 Lusaka. Price K64.00each. Supplement to the Republic of Zambia Government Gazette dated Friday, 5th February, 2016 233 234 Statutory Instruments 5th February, 2016 14. Identity of agro-veterinary shop 15. Sale of veterinary medicines 16. Sale, supply and dispensing of veterinarymedicines 17. Storage of veterinary medicines PART III GENERAL PROVISONS 18. Register of agro-veterinary shop permits 5th February, 2016 Statutory Instruments 235 IN EXERCISE of the powers contained in section twenty-nine of the Medicines and Allied Substances Act, 2013, the following Regulations are made: PART I PRELIMINARY 1. These Regulationsmay be cited as theMedicines andAllied Substances (Agro-Veterinary Shops) Regulations, 2016. 2. In these Regulations, unless the context otherwise requires— “authorised supplier” means a holder of a pharmaceutical licence issued under section thirty-four of the Act; “insanitary conditions”means the conditions or circumstances that could cause contamination of a medicine or allied substance with dirt or filth or could render the medicine or allied substance injurious or dangerous to health; “permit” means an agro-veterinary shop permit issued under section twenty-nine of the Act; and “responsible person” means a person who has the control and management of an agro-veterinary shop. PART II AGRO-VETERINARY SHOP PERMIT 3. (1) Aperson shall apply to theAuthority for a permit in Form I set out in the First Schedule. (2) TheAuthority shall, within fourteen days of the receipt of an application, notify the applicant of the decision of theAuthority in respect of the application. (3) A separate application shall be made and a separate permit issued in respect of each premises. (4) TheAuthoritymay inspect the premises in respect of which an application for a permit is made to determine if the applicant meets the requirements of theAct and the guidelines issued by the Authority. 4. The Authority may request an applicant to submit information in relation to an application for a permit in Form II set out in the First Schedule. Title Interpretation Application for permit Request for information 5. (1) The Authority shall reject an application for a permit if— (a) the applicant fails to meet the requirements of the Act and the guidelines issued by theAuthority; (b) the permit issued to the applicant was revoked by the Authority within a period of two years preceding the application; or (c) the applicant is convicted of an offence under the Act or any other relevant written law. (2) The Authority shall, where it rejects an application under subregulation (1), inform the applicant within seven days of the decision in Form III set out in the First Schedule. 6. (1) The Authority shall, where the applicant meets the requirements of theAct and the guidelines issued by theAuthroity, issue a permit in Form IV set out in the First Schedule. (2) A permit shall be valid for two years from the date of issue. (3) A permit may be issued in respect of the following classes of agroveterinary shops: (a) class I, to stock for sell the veterinarymedicines and allied substances specified in PartA of the Second Schedule; (b) class II, to stock for sale the veterinary medicines and allied substances as specified in Part B of the Second Schedule; and (c) class III, to stock for sale the veterinary medicines and allied substances specified in Part C of the Second Schedule. (4) The classes of agro-veterinary shops shall be management as follows: (a) class I, by a registered veterinary surgeon or pharmacist; (b) class II, by a registered veterinary para-professional under the supervision of a registered veterinary surgeon or pharmacist; and (c) class III, by a suitably qualified person as determined by theAuthority. 7. (1) An application for the renewal of a permit shall be made to the Authority in FormV set out in the First Schedule. (2) The Authority shall, within fourteen days of receipt of an application for the renewal of a permit, grant the application if the applicant meets the requirements of the Act and the guidelines issued by the Authority and has complied with the terms and conditions of the permit. 236 Statutory Instruments 5th February, 2016 Rejection of application for permit Issuance of permit Application for renewal of permit 5th February, 2016 Statutory Instruments 237 (3) Apermit that is not renewed by theAuthority lapses on its date of expiry. 8. (1) A permit shall be used solely by the holder and is not transferable to any other person without the prior approval of the Authority. (2) An application for approval to transfer a permit shall be made to the Authority in FormVI set out in the First Schedule. (3) The Authority shall, within thirty days of receipt of an application for the transfer of a permit, approve the transfer if the applicant meets the requirements of the Act and the guidelines issued by theAuthority and issue the transferee with a new permit. (4) TheAuthority shall reject an application for the transfer of a permit if the applicant fails to comply with the conditions for the grant of the permit, the provisions of the Act and the guidelines issued by the Authority. (5) The Authority shall, where it rejects an application to transfer a permit under subregulation (4), inform the applicant in Form III set out in the First Schedule. 9. (1) The Authority may amend a permit where— (a) some other person succeeds to the interest of the business of the holder; (b) the name of the business changes; or (c) there is a change in the employment of the responsible person. (2) An application for the amendment of a permit shall bemade in Form VII set out in the First Schedule. (3) TheAuthority shall communicate its decision to the permit holder within fourteen days of receipt of the application for amendment of the permit. (4) The Authority shall, where it approves the amendment of a permit, issue the applicant with a new permit. 10. Aperson may, where a permit is lost, damaged or defaced, apply to theAuthority for a duplicate permit in FormVIII set out in the First Schedule. 11. (1) TheAuthority shall suspend a permit if— (a) the holder operates the agro-veterinary shop in respect of which it is issued under insanitary conditions; Transfer of permit Amendment of permit Application for duplicate permit Suspension of permit 238 Statutory Instruments 5th February, 2016 (b) the holder or manager of the agro-veterinary shop in respect of which it is issued obtains or sells veterinary medicines from unauthorised suppliers or stocks and sells unauthorised products; (c) the agro-veterinary shop in respect of which it was issued contravenes the prescribed standards or the provisions of the Act; (d) the agro-veterinary shop is not managed or controlled by a responsible person determined by theAuthority; (e) the responsible person fails tomaintain the required records on veterinary medicines and allied substances; (f) the agro-veterinary shop stocks and sells medicines that are not on the prescribed list; or (g) the holder contravenes the terms and conditions of the permit, the provisions of the Act or any other relevant written law. (2) TheAuthority shall, before suspending a permit, give notice to the holder of the intention to suspend the permit and request the holder to show cause, within a specified period, why the permit should not be suspended. (3) A notice of intention to suspend a permit shall be in Form IX set out in the First Schedule. (4) The Authority shall suspend a permit if the holder of the permit fails to take remedial measures within the period specified in the notice issued under sub-regulation (2). (5) A notice of the suspension of a permit shall be in Form X set out in the First Schedule. (6) TheAuthority shall, during the period of the suspension of the permit, quarantine any product affected by the suspension of the permit at the cost of the permit holder. 12. (1) TheAuthority shall revoke a permit if the holder— (a) contravenes the provisions of theAct or any other relevant written law or breaches the terms or conditions of the permit; (b) fails to take corrective measures following the suspension of the permit within the specified period; (c) changes the agro-veterinary shop premises without authorisation; or (d) obtained the permit by fraud or deliberate or negligent submission of false information or statements. Revocation of permit 5th February, 2016 Statutory Instruments 239 (2) TheAuthority shall, before revoking a permit, give notice to the holder of the permit of the intention to revoke the permit and request the holder to show cause, within a specified period, why the permit should not be revoked. (3) A notice of the intention to revoke a permit shall be in Form IX set out in the First Schedule. (4) The Authority shall revoke a permit if the holder fails to take remedialmeasures during the period specified by theAuthority. (5) A notice of the revocation of a permit shall be in Form X set out in the First Schedule. (6) Upon the revocation of a permit, the medicines and allied substances on the premises shall be quarantined and disposed of as directed by the Authority at the holder’s cost. 13. TheAuthority shall, in considering an application for a permit, give priority to submissions filed by the applicants in the following areas: (a) rural areas and districts where access to medicines is limited; and (b) peripheral areas of municipalities or cities, where access tomedicines is limited. 14. An agro-veterinary shop shall fix a standard logo for purposes of identifying the agro-veterinary shop as specified in the guidelines issued by theAuthority. 15. A holder of a permit shall sell the veterinary medicines prescribed in the Second Schedule. 16. Veterinarymedicines shall be sold, supplied and dispensed in accordance with the guidelines issued by theAuthority. 17. (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. (2) Where veterinary medicines are transferred to another container, care shall be taken to protect the integrity of the product and prevent contamination of the medicines. (3) TheAuthority shall, where it is established that the holder of a permit stocks veterinarymedicines or products under insanitary conditions, direct the holder to dispose of the veterinarymedicines or products at the holder’s cost. Location of agro veterinary shop Identity of agro veterinary shop Sale of veterinary medicines Sale, supply and dispensing of veterinary medicines Storage of veterinary medicines 240 Statutory Instruments 5th February, 2016 PART III GENERAL PROVISIONS 18. (1) TheAuthority shall keep andmaintain a register of agro veterinary permits in Form XI set out in the First Schedule. (2) The register referred to in subregulation (1) shall be kept at the offices of the Authority and shall be open to inspection by the public at such times and upon payment of an inspection fee prescribed in the Third Schedule. Register of agro veterinary shop permits 5th February, 2016 Statutory Instruments 241 APPLICATION FOR AN AGRO-VETERINARY SHOP PERMIT Please complete in block letters Shaded fields for official use only Application No. Date and Time Information Required Information Provided PARTICULARS OF APPLICANT 1 . (a) Name of business entity (b) Registration No. 2 . Type of entity 3 . Business premises (a) Plot No: (b) Street: (c) Telephone No: (d) Fax No: (e) Mobile No: (f) Email address (g) Village (h) Chief (i) Town (j) District (k) Province 4 . Type of permit applied for Class I Class II Class III PROPOSED LOCATION OF AGRO-VETERINARY SHOP 5 . Name of agro-veterinary shop: 6 . Physical Address 7 . Postal Address PARTICULARS OF RESPONSIBLE PERSON 8 . (a) Name (b) Registration Certificate No. (c) Date: (d) Signature: 9 . Attachments Appendix 1 Valid Practicing Certificate or licence for the Responsible Person from the relevant professional body Appendix 2 Sketch of the floor plan of the premises FIRST SCHEDULE (Regulations 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) PRESCRIBED FORMS Form I (Regulation 3 (1)) (To be completed in triplicate) THEZAMBIAMEDICINESREGULATORYAUTHORITY The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) The Medicines and Allied Substances (Agro-Veterinary Shops) Regulations, 2016 242 Statutory Instruments 5th February, 2016 DECLARATION AND SIGNATURE I declare that all the information I have stated in this application is correct and truthful to the best of my knowledge and belief. I understand that submission of false information shall render the application void and that if approval is granted, it shall be revoked and the permit cancelled. Particulars of the Person signing on behalf of the Applicant ……………………………………………………………… ………………………………………………………….. Name Designation ……………………………………………………….. …………………………………………………………… Signature Date FOR OFFICIAL USE ONLY Date of Submission: …………………………………………………………………………………………………….. Application Number: ……………………………………………………………………………………….……….….. Payments Receipt Number: ……………………………………………………………………….…….….…………. Application Accepted (Proceed for Inspection): ……………………………………………………..…………….. Application Rejected (Notify applicant): ……………………..……………………………………………………… ………………………………………………………………….……………………………………………………………... OFFICIAL STAMP 5th February, 2016 Statutory Instruments 243 Form II (Regulation 4) THEZAMBIAMEDICINESREGULATORYAUTHORITY The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) The Medicines and Allied Substances (Agro-Veterinary Shops) Regulations, 2016 REQUESTFOR INFORMATION To: …………………………………………………………………………….…………. Address: ……………………………………………………………….……………….. Application No: ………………………………………………………………………. You are requested to furnish the following information or documents in respect of your application for…………………………………………………………………………….…. (a) ……………………………………………………………………………………….. (b) ……………………………………………………………………………………….. (c) ………………………………………………………………………………………. (d) ……………………………………………………………………………………….. within…………………….. days of this notice. If you fail to furnish the requested information within the stipulated period, your application will be treated as invalid and shall be rejected. Dated this………………… day of …………………….. 20……………………………. ………………………………. Director-General OFFICIAL STAMP 244 Statutory Instruments 5th February, 2016 Form III (Regulations 5(2) and 8(5)) THEZAMBIAMEDICINESREGULATORYAUTHORITY The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) The Medicines and Allied Substances (Agro-Veterinary Shops) Regulations, 2016 NOTICEOFREJECTIONOFAPPLICATION To (1)………………………………...........…………………............................. ………………………………………........................………………………… IN THE MATTER OF (2) ……………….................... you are notified that your application for (3)...................................................................has been rejected by the Authority on the following grounds: (a)………………….......................………………………………………………… (b)………………………………………….....................………..……………… (c)……………………………………….........................…..…………………. (d)…………………………………..…………………….....................………. Dated this ……………day of ………............……………….., 20………... ..................................................... Director-General (1) Here insert the full names and address of the applicant (2) Here insert the reference No. of the application (3) Here insert type of application OFFICIAL STAMP 5th February, 2016 Statutory Instruments 245 Form IV (Regulation 6) THEZAMBIAMEDICINESREGULATORYAUTHORITY The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) The Medicines and Allied Substances (Agro-Veterinary Shops) Regulations, 2016 AGRO-VETERINARYSHOPPERMIT Registration No.: …………………………………………… AVS Permit No.: AVS/ ……………………………………………. This is to certify that (Name of Agro-Veterinary Shop) ………………………………………… ……………………………………………………………………………..................................... of (Physical Address) …………………………………………….....................………………… ………………………………………………………....................………………………………. …………………………………………………..............………….. is registered to operate an agro-veterinary shop. Name of Responsible Person: ……………………………….................................................. The conditions of the agro-veterinary shop permit are overleaf. This permit is valid until ……………………… 20 ……...... ………………………………………… Director-General Conditions for Agro-Veterinary Shop Permit 1. Any change in the responsible person, name, location or condition of permit of the agro veterinary shop shall be approved by the Authority. 2. The agro-veterinary shop shall only stock and sell medicinal products that are on the prescribed list. 3. The premises and the manner in which the business is to be conducted must comply with the requirements of the Medicines and Allied Substances Act, No. 3 of 2013, and any other relevant written law. 4. The agro-veterinary shop permit is not transferable without the written approval of the Authority. 5. The agro-veterinary shop permit shall, upon grant, be displayed conspicuously at the front shop in a place visible to the public. 246 Statutory Instruments 5th February, 2016 5th February, 2016 Statutory Instruments 247 FormV (Regulation 7(1)) (To be completed in triplicate THEZAMBIAMEDICINESREGULATORYAUTHORITY The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) The Medicines and Allied Substances (Agro-Veterinary Shops) Regulations, 2016 APPLICATION FOR RENEWAL OF AGRO-VETERINARY PERMIT Please complete in block letters Shaded fields for official use only Application No. Date and Time Information Required Information Provided 1 . Permit No. 2 . Registration No. 2 . Name(s) of permit holder 3 . Address (a) Telephone No. (b) Fax No. (c) Mobile phone No. (d) Email address 4 . Appendix Annual Report (a) Monthly records of quantities of medicines ordered and received (b) Monthly records of names and receipts from authorized suppliers (c) Monthly records of prescriptions for POM-Vs/P-Vs dispensed (d) Monthly records of medicines stock-on-hand Name of Applicant (individual or authorised representative) Date:………………………………………………… Signature:………………………………………………. FOR OFFICIAL USE ONLY Received by: ………………………………………… Receipt No: ………………………………………… Amount Received: ……………………………….……….………………………………..…………………… Serial No. of application: ………………………………….………………… STAMP OFFICIAL 248 Statutory Instruments 5th February, 2016 Form VI (Regulation 8(2)) (To be completed in triplicate) THEZAMBIAMEDICINESREGULATORYAUTHORITY The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) The Medicines and Allied Substances (Agro-Veterinary Shops) Regulations, 2016 APPLICATION FOR TRANSFER OF AGRO-VETERINARY SHOP PERMIT Please complete in block letters Shaded fields for official use only Application No. Date and Time Information Required Information Provided PARTICULARS OF APPLICANT 1 . (a) Name of business entity (b) Registration No. 2 . Type of entity 3 . Business premises (a) Plot No: (b) Street: (c) Telephone No: (d) Fax No: (e) Mobile No: (f) Email address (g) Village (h) Chief (i) Town (j) District (k) Province 4 . Type of permit Class I Class II Class III PARTICULARS OF TRANSFEREE 1 . (a) Name of business entity (b) Registration No. 2 . Type of entity 3 . Business premises (a) Plot No: (b) Street: (c) Postal address (d) Telephone No: (e) Fax No: (f) Mobile No: (g) Email address (h) Village (i) Town (j) District (k) Province 5th February, 2016 Statutory Instruments 249 DECLARATION AND SIGNATURE I declare that all the information I have stated is correct and true to the best of my knowledge and belief. I understand that submission of false information shall render the application void, and if the permit has been granted, it shall be revoked. Particulars of the Person signing on behalf of the Applicant …………………………………………………………… ………………………………………………………….. Name Designation ………………………………………………………….. …………………………………………………………… Signature Date FOR OFFICIAL USE ONLY Date of Submission: …………………………………………………………………………………………………….. Application Number: ……………………………………………………………………………………….……….….. Payments Receipt Number: ……………………………………………………………………….…….….…………. Application Accepted (Proceed for Inspection): ……………………………………………………..…………….. Application Rejected (Notify applicant): ……………………..……………………………………………………… ………………………………………………………………….……………………………………………………………... OFFICIAL STAMP Form VII (Regulation 9) (To be completed in triplicate) THEZAMBIAMEDICINESREGULATORYAUTHORITY The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) The Medicines and Allied Substances (Agro-Veterinary Shops) Regulations, 2016 250 Statutory Instruments 5th February, 2016 APPLICATION FOR AMENDMENT OF AN AGRO-VETERINARY SHOP PERMIT Please complete in block letters Shaded fields for official use only Application No. Date and Time Information Required Information Provided PARTICULARS OF APPLICANT 1. (a) Name of business entity (b) Registration No. 2. Type of entity 3. Business premises (a) Plot No: (b) Street: (c) Telephone No: (d) Fax No: (e) Mobile No: (f) Email address (g) Village (h) Chief (i) Town (j) District (k) Province 4. PARTICULARS OF AMENDMENT DESCRIPTION OF AMENDMENT(S) 1. 2. 3. 5. EXISTING PROPOSED AMENDMENT REASONS FOR AMENDMENT 5th February, 2016 Statutory Instruments 251 DECLARATION AND SIGNATURE I declare that all the information I have stated is correct and true to the best of my knowledge and belief. I understand that submission of false information shall render the application void, and if the permit has been granted, it shall be revoked. Particulars of the Person signing on behalf of the Applicant ………………………………………………………… ………………………………………………………….. Name Designation ……………………………………………………….. …………………………………………………………… Signature Date FOR OFFICIAL USE ONLY Date of Submission: …………………………………………………………………………………………………….. Application Number: ……………………………………………………………………………………….……….….. Payments Receipt Number: ……………………………………………………………………….…….….…………. Application Accepted (Proceed for Inspection): ……………………………………………………..…………….. Application Rejected (Notify applicant): ………………………………..……………………….………………… ………………………………………………………………….……………………………………………………………... OFFICIAL STAMP 252 Statutory Instruments 5th February, 2016 Form VIII (Regulation 10) (To be completed in triplicate) THEZAMBIAMEDICINESREGULATORYAUTHORITY The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) The Medicines and Allied Substances (Agro-Veterinary Shops) Regulations, 2016 APPLICATION FOR DUPLICATE PERMIT Please complete in block letters Shaded fields for official use only Application No. Date and Time Information Required Information Provided 1 . Name of business entity 2 . Permit No. 3 . Registration No. 4 . Business Address 5 . District and locations of proposed activities Districts Location of proposed activities 6 . Affidavit DECLARATION AND SIGNATURE I declare that all the information I have stated is correct and truthful to the best of my knowledge and belief. I understand that submission of false information shall render the application void, and if the permit has been granted, it shall be revoked. Particulars of the Person signing on behalf of the Applicant …………………………………………………………… ………………………………………………………….. Name Designation ………………………………………………………….. …………………………………………………………… Signature Date FOR OFFICIAL USE ONLY Date of Submission: …………………………………………………………………………………………………….. Application Number: ……………………………………………………………………………………….……….….. Payments Receipt Number: ……………………………………………………………………….…….….…………. Application Accepted: …………………………………………………….……………………………………….….. Application Rejected (Notify applicant): ……………………………………………………………………………… ………………………………………………………………….………………………………………………………... OFFICIAL STAMP 5th February, 2016 Statutory Instruments 253 Form IX (Regulation 11 (3) and 12 (3)) (To be completed in triplicate) THEZAMBIAMEDICINESREGULATORYAUTHORITY The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) The Medicines and Allied Substances (Agro-Veterinary Shops) Regulations, 2016 NOTICE OF INTENTION TO SUSPEND/REVOKE AGRO-VETERINARY SHOP PERMIT (1) Here insert the full names and address of holder of permit (2) Here insert the Permit No. (3) Here insert the number of days stipulated (4) Signature of Director General To (1)..................................................................................................... ............................................................................................................. ............................................................................................................. IN THE MATTER OF (2) ............................................. you are notified that the Authority intends to *suspend/revoke your permit on the following grounds: (a) .......................................................................................................... (b) ........................................................................................................... (c) ........................................................................................................... (d) ........................................................................................................... Accordingly, you are requested to show cause why your permit should not be suspended/revoked and to take action to remedy the breaches set out in paragraphs..................................................(above) within (3)................days of receiving this notice. Failure to remedy the said breaches shall result in the *suspension/revocation of your permit. Dated this........................day of ........................................20......................... (4)..................................................... Director-General *Delete as appropriate OFFICIAL STAMP 254 Statutory Instruments 5th February, 2016 Form X (Regulation 11 (5) and 12 (5)) (To be completed in triplicate) THEZAMBIAMEDICINESREGULATORYAUTHORITY The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) The Medicines and Allied Substances (Agro-Veterinary Shops) Regulations, 2016 NOTICE OF SUSPENSION OR REVOCATION OF AGRO-VETERINARY SHOP PERMIT (1) Here insert the full names and address of holder of Permit (2) Here insert the Permit No. (3) Here insert the period (4) Signature of Director General To (1) .................................................................................................... ................................................................................................................. IN THE MATTER OF (2) ...................................you are notified that your permit has been *suspended for a period of (3) ............../*revoked on the following grounds: (a) .......................................................................................................... (b) ........................................................................................................... (c) ........................................................................................................... (d) ........................................................................................................... Dated this ................................day of ........................................20............... (4) ............................................... Director-General OFFICIAL STAMP 5th February, 2016 Statutory Instruments 255 Form XI (Regulation 19)) THEZAMBIAMEDICINESREGULATORYAUTHORITY The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) The Medicines and Allied Substances (Agro-Veterinary Shops) Regulations, 2016 REGISTEROFAGRO-VETERINARYSHOPPERMITS No. Name and Address of business Permit No. Class of Permit Registration number Date of issue Expiry Date 1. 2. 3. 4. 5. 6. 7. 256 Statutory Instruments 5th February, 2016 SECOND SCHEDULE (Regulations 16(3) and 15(1)) VETERINARY PRODUCTS FORAGRO-VETERINARY SHOPS A. Agro-Veterinary Shop Class I 1. All Prescription-only veterinary Medicine (POM-V) with marketing authorisation 2. All Pharmacy (P-V) veterinary medicines with market authorisation 3. All general sales (GS-V) veterinarymedicines and allied substances 4. All medicines that have been imported with special authorisation 5. Medicines and allied substances added by guidelines issued by the Authority on the recommendation of the Ministry responsible for veterinary services in response to changing disease epidemiological status or disease outbreaks B. Agro-Veterinary Shops Class II PartA No. Item Dosage Form 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 FlunixinMeglumine 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 solutions granules 7 Imidocarb Dipropionate Injectable solutions 8 Isometamidium chloride Injectable solutions 9 Parvarquone Injectable solutions power 10 Quinapyramine Sulphate/Chloride Injectable solutions 5th February, 2016 Statutory Instruments 257 Antifungals 1 Fluconazole Tablets or powder 2 Griseofulvin Tablets or capsules 3 Ketoconazole Tablets, capsules, lotions shampoo Antihistamines 1 Chlorpheniramine Tablets 2 Cimetidine Tablets 3 Diphenhydramine Tablets 4 Cetirizine Tablets 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 SodiumChloride 0.9% (N-Saline) Solution 15 Dextrose 5%, 10%, 50% Solution 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 258 Statutory Instruments 5th February, 2016 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 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 5th February, 2016 Statutory Instruments 259 260 Statutory Instruments 5th February, 2016 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 ChickenAnaemia 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 7 Infectious bronchitis/Newcastle disease/egg All dosage forms drop syndrome Vaccines 8 Infectious bronchitis/Newcastle All dosage forms Inactivated Vaccines 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 vaccine All dosage forms 14 Newcastle disease Inactivated vaccines All dosage forms 15 Newcastle disease Thermostable vaccines All dosage forms 16 Salmonella Vaccines for avians All dosage forms 17 Egg drop syndrome vaccines All dosage forms Ruminant Vaccines 1 Anaplasmosis Vaccines All dosage forms 2 Anthrax vaccines All dosage forms 3 Avian & Bovine tuberculin kit Injectible 4 Black leg -Clostridium chauvoei Vaccines All dosage forms 5 Blackleg/Anthrax Vaccines All dosage forms 6 Blue tongue Vaccines All dosage forms 7 BotulismVaccines All dosage forms 8 Botulism/Anthrax Vaccines All dosage forms 5th February, 2016 Statutory Instruments 261 9 Anthrax/black quarter/botulismVaccines All dosage forms 10 Bovine Ephemeral fever Vaccines All dosage forms 11 BrucellaVaccines All dosage forms 12 Calf Paratyphoid Live and killed vaccines All dosage forms 13 Enzootic abortion Vaccines All dosage forms 14 Clostridial/Pasteurella Vaccines All dosage forms 15 Infectious bovine rhinotracheitis/parainfluenza All dosage forms / bovine respiratory syncitial virus/bovine viral diarrhoea (combination) Vaccines, both live and killed 16 Leptospirosis Vaccines All dosage forms 17 Lumpy skin disease Vaccines All dosage forms 18 Milk ring test Antigen All dosage forms 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 24 Rift Valley Fever Live Vaccine for sheep All dosage forms 26 Bovine Rota/Coronavirus Vaccine/ Clostridium All dosage forms Perfringens Type C/Escherichia Coli Bacterin/ Toxoid Injectable vaccine/toxoid 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 / All dosage forms Leptospira Bacterin Vaccine/toxoid 2 Boar-taint vaccine Vaccines All dosage forms 3 E. coli/Clostridium Perfringens type C beta toxoid All dosage forms 262 Statutory Instruments 5th February, 2016 Vaccines for companion animals 1 Equine Influenza virus Vaccines All dosage forms 2 Feline viral rhinotracheitis/feline calicivirus/ All dosage forms feline panleukopenia Vaccines 3 Canine Parvovirus Vaccines All dosage forms 4 Horse Sickness Polyvalent vaccine All dosage forms 5 Canine Distemper/Adenovirus Type 2/ All dosage forms Parainfluenza/Parvovirus modified live virus vaccine/ Leptospira BacterinVaccine/toxoid 6 RabiesVaccines All dosage forms Intra-uterine infusion drugs 1 Intrauterine pessaries Pessaries 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 Power or ointment Antiseptics 1 Povidone Iodine Concentrate 5th February, 2016 Statutory Instruments 263 Part B 1. All general sales (GSV) veterinary medicines and allied substances 2. Medicines and allied substances added by guidelines issued by the Authority on the recommendation of theMinistry responsible for veterinary services in response to changing disease epidemiological status or disease outbreaks Agro-Veterinary shop Class III PartA No. Item Dosage Form Analgesics-non-steroidal Anti-Inflammatories 1 Diclofenac Tablets or gel 2 Dipyrone Injection Antiprotozoa 1 Amprolium Soluble powders 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 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 Power or ointment 264 Statutory Instruments 5th February, 2016 Part B 1. All general sales (GSV) veterinarymedicines and allied substances 2. Medicines and allied substances added by guidelines issued by the Authority, 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, shall only be accessed from registered pharmacies on prescription from a registered veterinary surgeon. DR J. KASONDE, LUSAKA Minister of Health 27th January, 2016 [MH.101/16/1]