Commencement

These Regulations shall come into force on the 12th day of December, 2001. MADE by the Minister responsible for Agriculture, Fisheries and Cooperatives this 12th day of December, 2001. (DANIEL SILVA) Minister responsible for Agriculture, Fisheries and Cooperatives 104 FIRST SCHEDULE (Regulation 9) PROCEDURE FOR THE REGISTRATION OF ALL VETERINARY DRUGS, PESTICIDES AND ANIMAL FEED PERMITTED FOR USE IN BELIZE PART I Procedure for Registration Interpretation. 1.–(1) In this Schedule, unless the context otherwise requires“certificate of registration” means a certificate showing that a veterinary drug, veterinary pesticide or animal feed has been registered pursuant to this Schedule and regulation 9 of the Regulations; “label” means any brand or mark or any written, pictorial or other descriptive matter appearing on or attached to or packed with any veterinary drug, veterinary pesticide or animal feed or its package and, when used as a verb, means to brand or mark or to attach or to provide in any other manner, with any written, pictorial or other descriptive matter; “logo” means a trademark used by a manufacturer of veterinary drugs, veterinary pesticides or animal feed to designate its product or range of products; “product” means a registered veterinary drug, veterinary pesticide or animal feed in the form in which it is packaged and sold; “registered veterinary drug”, “registered veterinary pesticide” or “registered animal feed’’ means a drug, pesticide or animal feed registered under regulation 9 and this Schedule, in respect of which there is a current certificate of registration; “trade name” means the name under which a registered veterinary product, registered veterinary pesticide or animal feed is registered, packaged and sold by the manufacturer, which is used exclusively by the manufacturer as a trade-mark to distinguish the product from other registered veterinary products, registered veterinary pesticides or animal feed. (2) A word or phrase used in this Schedule which is not defined herein but which is defined in the Regulations shall have the meaning assigned to it in the Regulations. Application for registration. 2.–(1) A registered veterinarian, or an owner of veterinary drugs, pesticides or animal feed desirous of selling or using a veterinary drug, pesticide or animal feed in Belize shall make written application to the Unit pursuant to this Schedule I to have the veterinary drug, pesticide or animal feed registered under regulation 9 of the Regulations. (2) The written application referred to in subparagraph (1) shall be in the form set out in Part II of this Schedule and shall be accompanied by the appropriate fee set out in paragraph 6 of this Schedule. (3) The written application referred to in subparagraph (1) shall additionally be accompanied by– (a) the trade name of the veterinary drug, veterinary pesticide or animal feed, or the logo used for the purposes of marketing the product; (b) the maximum residue limit of the veterinary drug or veterinary pesticide, for veterinary drugs or pesticide used to treat food animals; (c) details of the labels of the veterinary drug, veterinary pesticide or animal feed, including three copies of the proposed label for approval by the Unit. 106 (4) Where a veterinary drug, veterinary pesticide or animal feed has been registered pursuant to this Schedule, it shall not be a requirement to register such veterinary drug, veterinary pesticide or animal feed before using or selling it. Procedure upon receipt of application. 3.–(1) Upon receiving an application made under paragraph 2, the Registrar shall satisfy himself that– (a) the application complies with the form set out in Part II of this Schedule; (b) the application is accompanied by the appropriate fee set out in paragraph 6 of this Schedule; (c) all the documents and information referred to in subparagraph (3) of paragraph 2 of this Schedule have accompanied the application. (2) The Registrar shall– (a) if the application is accompanied by all the required documents, information and fee, place the application before the Unit for consideration; (b) if the application is not accompanied by all the required documents, information, fee, or is incomplete or deficient in some material respect, return the application to the applicant. (3) Where the Registrar returns an application to an applicant under subparagraph (2)(b), the Registrar shall inform the applicant of the steps which the applicant should take in order to complete the application in accordance with the requirements of this Schedule. (4) Every application placed before the Unit by the Registrar under subparagraph (2)(a) shall be considered and either approved or rejected by the Unit within fourteen days. (5) Where the Unit rejects an application under subparagraph (4), it shall give written notice thereof to the applicant, including the grounds of the rejection. (6) An applicant aggrieved by a decision of the Unit not to register its veterinary drug may appeal against such decision to the Managing Director within fourteen days of the receipt of such decision, and the Managing Director’s decision on the appeal shall be final. Provisional registration. 4.–(1) Subject to subparagraph (2), where the Unit, after considering an application for the registration of a veterinary drug, pesticide or animal feed under regulation 9 of the Act and this Schedule, and after considering all the surrounding circumstances of the application, is not satisfied that a veterinary drug, pesticide or animal feed should be registered, it may grant provisional registration for use subject to such conditions as it may lay down, for a period not exceeding one year, after which– (a) the veterinary drug, pesticide or animal feed shall either be registered as a veterinary drug, pesticide or animal feed; or (b) the provisional registration may be withdrawn by the Unit. (2) No veterinary drug, pesticide or animal feed used to treat food animals shall be provisionally registered. 5.–(1) All veterinary drugs, and pesticides shall be registered, or provisionally registered, asTypes of certificates of registration. (a) over-the-counter; or (b) prescription-only; or 108 (c) restricted, and the relevant certificate shall be issued to the applicant upon decision by the Unit under paragraph 3(4) or 4(a), whichever applies. (2) Certificates of registration shall be in the form set out in Part III of this Schedule. 6.–(1) The following fees shall be payable on the provisional registration or registration of each– (a) over-the-counter veterinary drug or veterinary pesticide ………………........................ $100; (b) prescription-only veterinary drug or veterinary pesticide ………….......................……. $200; (c) restricted veterinary drug or veterinary pesticide …………………………........ $300; (d) animal feed …………............................ $150. (2) The same applicable fees set out in subparagraph (1) shall be payable on the renewal of each registration of a veterinary drug or veterinary pesticide. (3) The same applicable fees set out in subparagraph (1) shall be payable for the registration of a veterinary drug or veterinary pesticide which was previously provisionally registered. Duration of certificates of registration. 7. A certificate of registration for a veterinary drug granted by the Unit under this Schedule shall be valid for three years. 8. If, after a veterinary drug, veterinary pesticide or animal feed has been registered, it comes to the knowledge of the Unit that the registration was procured by false or misleading information or the concealment of material facts, the Unit may cancel the registration with immediate effect, after inviting the holder of the registration to show cause why it should not be cancelled, and the fee in respect of the registration shall be forfeited. Cancellation of registration. 110 PART II Application Form 1. The Registrar of Veterinary Drugs, Veterinary Pesticides and Animal Feed Belize Agricultural Health Authority Belmopan Belize 2. Date: ______________ 3. Name of Applicant: ________________________________________ 4. Address of Applicant: ______________________________________ ________________________________________________________ 5. Telephone Number/Email Address of Applicant: _________________ ________________________________________________________ 6. Is Applicant a Registered Veterinarian or Owner of the Veterinary Drug, Veterinary Pesticide or Animal Feed? (Choose one) ________________________________________________________ 7. Common Name of Veterinary Drug/Veterinary Pesticide/Animal Feed: ________________________________________________________ 8. Trade name of Veterinary Drug/Veterinary Pesticide/Animal Feed: ________________________________________________________ 9. Maximum Residue Limit of Veterinary Drug/Veterinary Pesticide: ________________________________________________________ 10. Details of Labels of the Veterinary Drug, Veterinary Pesticide or Animal Feed (Also attach 3 copies) ________________________________________________________ 11. Type of Animals on which Veterinary Drug, Veterinary Pesticide Animal Feed may be used: ___________________________________ _________________________________________________________ 12. Classification of Veterinary Drug or Veterinary Pesticide (Tick appropriate). If you do not know the appropriate box to tick, leave blank: (a) Over-the counter □ (b) Prescription-only □ (c) Restricted □ 13. Is Veterinary Drug, Veterinary Pesticide or Animal Feed being manufactured in Belize at time of application? (Tick appropriate) Yes □ No □ 14. If the answer to 13 above is NO, provide details of registration in: (a) Country of manufacture (attach copies, if possible): ______________________________________________________ (b) Any other countries where drug/pesticide/animal feed is registered _____________________________________________________ 15. Has registration of the drug, pesticide/animal feed ever been refused in another jurisdiction? (Tick appropriate) Yes □ No □ If YES, provide details and reasons for such refusal: _______________ _________________________________________________________ 16. Fees included: _____________________________________________ _________________________________________________________ 112 17. Declaration by Applicant: I hereby declare that all the information provided in this application is true and correct to the best of my knowledge and belief, and I understand that if the Unit discovers that any information in this application was fraudulent or misleading, or that I have concealed material facts herein, the registration of the veterinary drug, veterinary pesticide or animal feed which I hereby apply for, may be cancelled and the fee forfeited. ___________________ Signature of applicant FOR OFFICIAL USE ONLY 1. Application received: _______________________________________ 2. Fees paid: ________________________________________________ 3. Application complete/incomplete: _____________________________ 4. If application is incomplete, details of required follow-up communicated to applicant and date: ___________________________ _________________________________________________________ 5. Registration status: _________________________________________ 6. Other remarks: ____________________________________________ _________________________________________________________ Date: ____________________________________________________ Signed: _______________________ Registrar PART III VETERINARY DRUGS CONTROL UNIT BELIZE AGRICULTURAL HEALTH AUTHORITY CERTIFICATE OF REGISTRATION OF A VETERINARY DRUG THIS IS TO CERTIFY that ______(the applicant)____________ of ______(address)____________________ has as of the _____ day of ________________, 20_____, been granted this Certificate of Registration pursuant to regulation 9 and Schedule I of the Belize Agricultural Health Authority (Veterinary Drugs and Animal Feed) (Registration and Control) Regulations, 2001, and that the drug/pesticide/animal feed commonly known as _________________________; whose trade name is _________________________; has been registered as of the same date as over-the-counter*/prescription-only*/restricted* and may by virtue of such regulation be sold and use in Belize for the treatment or feeding of ______(Specify)__________ animals. THIS CERTIFICATE is valid for three years from the date of issuance hereof. WITNESS my hand and the Public Seal of the Veterinary Drugs Control Unit this _____ day of ____________________, 20_____. ____________________ REGISTRAR *Delete inappropriate. 114 SECOND SCHEDULE (Regulation 11(2) and (3)) LIST OF BANNED VETERINARY DRUGS WHICH SHALL NOT BE USED, SOLD OR MANUFACTURED, DISTRIBUTED OR IMPORTED INTO BELIZE FOR TREATING FOOD ANIMALS 1. Chloramphenicol. 2. Clenbuterol 3. Diethystilbestrol (DES). 4. Dimetridazole. 5. Ipronidazole. 6. Other Nitroimidazoles. 7. Furazolidine (except for approved topical use). 8. Nitrofurazone (except for approved topical use). 9. Sulfonamide drugs in lactating diary cattle (except approved use of sulfadimethoxine, sulfabromomenthazine, and sulfaethoxypyridazine). 10. Fluoroquinolones. 11. Glycopeptides. THIRD SCHEDULE (Regulation 12) PROCEDURE FOR THE REGISTRATION OF PREMISES, ETC., SELLING, ETC., VETERINARY DRUGS, VETERINARY PESTICIDES OR ANIMAL FEED 116 FOURTH SCHEDULE (Regulation 15(2)) PART I Procedure for the Issuance, Suspension or Revocation of an Importer’s Licence Interpretation. 1. In this Schedule, unless the context otherwise requires a word or phrase used and not defined in this Schedule but defined in the Regulations shall have the meaning assigned to it in the Regulations. Licence to import a registered veterinary drug, etc. 2.–(1) Any person desirous of importing a veterinary drug, veterinary pesticide or animal feed into Belize shall make application to the Unit in the form set out in Part II of this Schedule. (2) No person shall import the veterinary drugs listed in the Second Schedule to the Regulations for the purpose of treating food animals. (3) The application referred to in subparagraph (1) shall be in the form set out in Part II of this Schedule and shall be accompanied by the appropriate fee set out in paragraph 3 of this Schedule. Import licence fees. 3. The annual import licence fee for a licence shall be determined by the Unit after consultation with persons interested in the importation of veterinary drugs, pesticides and animal feed. Procedure upon receipt of application. 4.–(1) Upon receiving an application for an import licence, the Registrar shall ensure that the appropriate fee accompanies the application, and shall then place it before the Unit for consideration. (2) Where an application is not accompanied by the appropriate fee, the Registrar shall return the application to the applicant, with instructions to resubmit the application. (3) Every application placed before the Unit by the Registrar shall be considered by the Unit within fourteen days, and the Unit may approve the application and issue the relevant import licence or refuse the application and inform the applicant in writing of the grounds for such refusal. (4) Any applicant aggrieved by the decision of the Unit not to issue an import licence may appeal against such decision to the Managing Director of the Authority within fourteen days of the receipt of such decision, and the Managing Director’s decision on the appeal shall be final. Duration of licenses. 5.–(1) An import licence issued by the Unit under this Schedule shall be valid for one year. (2) An import licence may be issued subject to conditions imposed by the Unit in connection with that licence. (3) An import licence shall be in the form set out in Part III of this Schedule. 6.–(1) If, after an import licence has been issued by the Unit under this Schedule, it comes to the knowledge of the Unit that the licence was procured by false or misleading information or the concealment of material facts, the Unit may revoke the licence with immediate effect, after inviting the holder of the licence to show cause why it should not be revoked, and the fee in respect of the issuance of the licence shall be forfeited. Revocation of import licences. (2) An import licence may be suspended by the Unit for a specified duration if the holder thereof breaches any of the conditions imposed by the Unit in connection with the issuance of that licence. 118 (3) Any person who contravenes this paragraph shall be liable to a penalty which may take the form of a reprimand, but which may extend to a monetary penalty determined by the Unit after taking into account all the circumstances of the contravention. PART II Application Form for an Import Licence 1. The Registrar of Veterinary Drugs, Veterinary Pesticides and Animal Feed Belize Agricultural Health Authority Belmopan Belize 2. Date: ______________ 3. Name of Applicant: ________________________________________ 4. Address of Applicant: ______________________________________ 5. Telephone Number/Email Address of Applicant: _________________ ________________________________________________________ 6. Is Applicant a Registered Veterinarian? (Tick appropriate box) Yes □ No □ 7. Common Name of Veterinary Drug/Veterinary Pesticide/Animal Feed for which application for import licence is made: ________________________________________________________ 8. Is Veterinary Drug/Veterinary Pesticide/Animal Feed being manufactured or distributed in Belize at date of application? Yes □ No □ (Tick appropriate box) If Yes, give reasons for the desired importation: ________________________________________________________ 9. Types of animals on which Veterinary Drug/ Veterinary Pesticide/ Animal Feed sought to be imported may be used (specify): (i) ______________________________________________________ (ii) _____________________________________________________ (iii) _____________________________________________________ 120 10. Classification of Veterinary Drug or Veterinary Pesticide (see regulation 9): ________________________________________________________ 11. Fee included: Yes □ No □ 12. Class of import licence applied for (specify): ____________________ ________________________________________________________ Declaration by Applicant: I hereby declare that all the information provided in this application is true and correct to the best of my knowledge and belief, and I understand that if an import licence is granted due to any fraudulent or misleading information in this application, or due to the concealment of material information, such licence may be revoked by the Unit and the fee forfeited. ___________________ Signature of Applicant FOR OFFICIAL USE ONLY 1. Application received: ______________________________________ 2. Fees paid: _______________________________________________ 3. Application submitted to Unit on: _____________________________ 4. Status of Application: Approved/Refused and reasons (if refused) ________________________________________________________ 5. Import Licence issued on: ___________________________________ 6. Other remarks: ____________________________________________ 7. Date: ___________________________________________________ Signed _____________________ Registrar PART III BELIZE AGRICULTURAL HEALTH AUTHORITY VETERINARY DRUGS CONTROL UNIT FORM OF IMPORT LICENCE IMPORT LICENCE NUMBER: ____________________ DATE ISSUED: ____________________ THIS IS TO CERTIFY that _____(name of applicant_____ of _____(address of applicant)____, is as of the _____ day of __________, 20 _____, licensed under a licence to import into Belize ______________ under licence. THIS LICENCE is valid: ____________________ THIS LICENCE is issued subject to the following conditions1. __________(specify conditions, if any)___________________ 2. ___________________________________________________ 3. ___________________________________________________ WITNESS my hand and the Public Seal of the Veterinary Drugs Control Unit this _____ day of _________, 20 _____. ____________________ Registrar 122 FIFTH SCHEDULE [Section 16 (2)] PART I Procedure for the Issuance, Suspension or Revocation of a Manufacturer’s Licence Interpretation. 1.–(1) In this Schedule, unless the context otherwise requires“manufacturer” means a person licensed as a manufacturer under Part VI of the Regulations; “manufacturer’s licence” means a licence to manufacture veterinary drugs, veterinary pesticides or animal feed in Belize issued by the Unit under Part VI of the Regulations and pursuant to this Schedule. (2) A word or phrase used and not defined in this Schedule but defined in the Regulations shall have the meaning assigned to it in the Regulations. Manufacturer’s licence. 2.–(1) Any person desirous of manufacturing a veterinary drug, veterinary pesticide or animal feed shall make application to the Unit. (2) No person shall manufacture the veterinary drugs listed in the Second Schedule for the purpose of treating food animals. (3) Subject to subparagraph (1), any person desirous of manufacturing a registered veterinary drug, veterinary pesticide or animal feed shall make written application to the Unit for a manufacturer’s licence, in the form set out in Part II of this Schedule. (4) The application referred to in subparagraph (1) shall be in the form set out in Part II of this Schedule, and shall be accompanied by the appropriate fee set out in paragraph 3 of this Schedule. Manufacturer’s licence fee. 3. The fee payable for a manufacturer’s licence shall be $750 per annum, or such other amount determined by the Unit after consultation with manufacturers of veterinary drugs, veterinary pesticide or animal feed in Belize. Procedure upon receipt of application. 4.–(1) Upon receiving an application for a manufacturer’s licence, the Registrar shall ensure that the appropriate fee accompanies the application, and shall then place it before the Unit for consideration. (2) Where an application is not accompanied by the appropriate fee, the Registrar shall return the application to the applicant, with instructions to resubmit the application. (3) Every application placed before the Unit by the Registrar shall be considered by the Unit within fourteen days, and the Unit may approve the application and issue the manufacturer’s licence, or refuse the application and inform the applicant in writing of the grounds for such refusal. (4) An applicant aggrieved by the decision of the Unit not to issue a manufacturer’s licence may appeal against such decision to the Managing Director of the Authority within fourteen days of the receipt of such decision, and the Managing Director’s decision on the appeal shall be final. 5.–(1) A manufacturer’s licence issued by the Unit under this Schedule shall be valid for one year. Duration and form of manufacturer’s licences. (2) A manufacturer’s licence may be issued subject to conditions imposed by the Unit in connection with that licence. (3) A manufacturer’s licence shall be in the form set out in Part III of this Schedule. 124 Revocation of manufacturer’s licences. 6.–(1) If, after a manufacturer’s licence has been issued by the Unit under this Schedule, it comes to the knowledge of the Unit that the licence was procured by false or misleading information or the concealment of material facts, the Unit may revoke the licence with immediate effect, after inviting the holder of the licence to show cause why the licence should not be revoked, and the fee in respect of the issuance of the licence shall be forfeited. (2) A manufacturer’s licence may be suspended by the Unit if the holder thereof breaches any conditions imposed by the Unit in connection with the issuance of that licence. (3) Any person who contravenes this paragraph shall be liable to a penalty which may take the form of a reprimand, but which may extend to a monetary penalty determined by the Unit after taking into account all the circumstances of the contravention. PART II Application Form for a Manufacturer’s Licence 1. The Registrar of Veterinary Drugs, Veterinary Pesticides and Animal Feed Belize Agricultural Health Authority Belmopan Belize 2. Date: ______________ 3. Name of Applicant: ________________________________________ 4. Business Address of Applicant: ______________________________ 5. Telephone Number/Email Address of Applicant: _________________ ________________________________________________________ 6. Is Applicant a Registered Veterinarian? (Tick appropriate box) Yes □ No □ 7. Common Name of Veterinary Drug/Veterinary Pesticide/Animal Feed for which application for manufacturer’s licence is made: ________________________________________________________ 8. Is Veterinary Drug/Veterinary Pesticide/Animal Feed being manufactured or distributed in Belize at date of application? Yes □ No □ (Tick appropriate box) ________________________________________________________ 9. Types of animals on which Veterinary Drug/ Veterinary Pesticide/ Animal Feed sought to be manufactured may be used (specify): (i) ______________________________________________________ (ii) _____________________________________________________ (iii) _____________________________________________________ 126 10. Classification of Veterinary Drug or Veterinary Pesticide (see regulation 9): ________________________________________________________ 11. Fee included: Yes □ No □ 12. Business plans for the applicant for the next year (specify and attach additional information if necessary) ________________________________________________________ Declaration by Applicant: I hereby declare that all the information provided in this application is true and correct to the best of my knowledge and belief, and I understand that if a manufacturer’s licence is granted due to any fraudulent or misleading information in this application, or due to the concealment of material information, such licence may be revoked by the Unit and the fee forfeited. ___________________ Signature of Applicant FOR OFFICIAL USE ONLY 1. Application received: ______________________________________ 2. Fees paid: _______________________________________________ 3. Application submitted to Unit on: _____________________________ 4. Status of Application: Approved/Refused and reasons (if refused) ________________________________________________________ 5. Manufacturer’s Licence issued on: ____________________________ 6. Other remarks: ____________________________________________ 7. Date: ___________________________________________________ Signed _____________________ Registrar PART III BELIZE AGRICULTURAL HEALTH AUTHORITY VETERINARY DRUGS CONTROL UNIT FORM OF MANUFACTURER’S LICENCE MANUFACTURER’S LICENCE NUMBER: ______________________ DATE ISSUED: ____________________ THIS IS TO CERTIFY that _____(name of applicant_____ of _____(address of applicant)____, has been granted a manufacturer’s licence to manufacture __________(specify)__________. THIS LICENCE is valid for one year (and is issued subject to the following conditions)1. __________(specify conditions, if any)___________________ 2. ___________________________________________________ 3. ___________________________________________________ WITNESS my hand and the Public Seal of the Veterinary Drugs Control Unit this _____ day of _________________, 20 _____. ____________________ Registrar