Veterinary Medicinal Products, Medicated Feed and Fertilisers Regulation Act 2023

Veterinary Medicinal Products, Medicated Feed and Fertilisers Regulation Act 2023 Skip to content Disclaimer Feedback Helpdesk Gaeilge Léim go dtí an t-ábhar Séanadh Aiseolas Deasc chabhrach English Gaeilge English Produced by the Office of the Attorney General Táirgthe ag Oifig an Ard-Aighne Home Legislation Acts of the Oireachtas Statutory Instruments Pre-1922 Legislation Constitution External Resources Bills (Houses of the Oireachtas) Iris Oifigiúil / Official Gazette Revised Acts (LRC) Classified List of Legislation (LRC) Translations (acts.ie) Translations (Houses of the Oireachtas) Government Publications for Sale EU Law (EUR-Lex) FAQ Disclaimer Feedback Helpdesk Search Baile Reachtaíocht Achtanna an Oireachtais Ionstraimí Reachtúla Reachtaíocht Réamh-1922 Bunreacht Acmhainní Seachtracha Billí (Tithe an Oireachtais) Iris Oifigiúil Achtanna Athbhreithnithe (CAD) (An Coimisiún um Athchóiriú an Dlí) Liosta Rangaithe Reachtaíochta Aistriúcháin (achtanna.ie) Aistriúcháin (Tithe an Oireachtais) Foilseacháin Rialtais ar Díol Dlí AE (EUR-Lex) CCanna (Ceisteanna Coitianta) Séanadh Aiseolas Deasc chabhrach Cuardach TitleTeideal Year(s) or rangeBliain nó blianta nó raon TypeCineál All Legislation Acts Statutory Instruments Advanced SearchCuardach Casta HomeBaile ActsAchtanna 2023 Veterinary Medicinal Products, Medicated Feed and Fertilisers Regulation Act 2023 Veterinary Medicinal Products, Medicated Feed and Fertilisers Regulation Act 2023 Permanent Page URL View by SectionAmharc de réir Ailt View Full ActAmharc ar an Acht Iomlán Bill History Stair Bille Commencement, Amendments, SIs made under the Act Tosach Feidhme, Leasuithe, IRí arna ndéanamh faoin Acht Open PDFOscail PDF Print Full ActPriontáil an tAcht Iomlán Number 21 of 2023 VETERINARY MEDICINAL PRODUCTS, MEDICATED FEED AND FERTILISERS REGULATION ACT 2023 CONTENTS PART 1 Preliminary Section 1. Short title, collective citation and commencement (section 7) 2. Repeals, revocation and dissolution 3. Expenses PART 2 Regulation of veterinary medicinal products and medicated feed Chapter 1 Interpretation 4. Interpretation (Part 2) Chapter 2 Veterinary medicinal products and medicated feed - prescriptions and dispensing - national database 5. Prohibitions 6. Prescriptions and dispensing - veterinary medicinal products, etc. 7. National database 8. Prescriptions under Article 105 of VMP Regulation and Article 16 of Medicated Feed Regulation Chapter 3 Rules on retail 9. Purpose of Chapter 3 10. Definitions (Chapter 3) 11. Route of retail 12. Restriction on retail of veterinary medicinal products 13. Labelling of veterinary medicinal products 14. Prohibition on retail of veterinary medicinal product after expiry date 15. Exemption from manufacturing authorisation 16. Labelling veterinary medicinal products retailed out of their original outer packaging 17. Restriction on use of premises 18. Veterinary medicinal product retailer’s licence 19. Obligations of holder of retailer’s licence 20. Training 21. Companion animal medicine retailers’ register 22. Record-keeping for veterinarian, pharmacist and retailer’s licence holder 23. Fixed premises 24. Retail at distance 25. Licencing of import of medicinal products in relation to their use under Articles 110 to 114 or 116 of VMP Regulation 26. Regulations - rules on retail Chapter 4 Control of possession and administration of veterinary medicinal products or medicated feed 27. Prohibition on possession of veterinary medicinal products or medicated feed 28. Administration of veterinary medicinal products or medicated feed Chapter 5 Storage, advertising and licensing certain veterinary medicinal products, etc. 29. Regulations - secure storage, etc. of veterinary medicinal products 30. Advertising of veterinary medicinal products or medicated feed 31. Licence required for certain activities Chapter 6 Matters under national law mentioned in VMP Regulation or Medicated Feed Regulation 32. Regulations - additional to VMP Regulation and Medicated Feed Regulation Chapter 7 Administrative - Regulations and licences 33. Regulations - Part 2 34. Licences generally - Part 2 Chapter 8 Enforcement 35. Authorised officers 36. Search warrant 37. Search of suspects and stopping of vehicles 38. Power of arrest 39. Saving for certain power 40. Obstruction 41. Compliance notice 42. Appeal against compliance notice 43. Seizure and detention for non-compliance with compliance notice 44. Impersonation of authorised officer, etc. and possession of certain identity documents 45. Evidence of class of veterinary medicinal product to which contravention relates 46. Disposal of things seized 47. Evidence on certificate, etc. 48. Offences by bodies corporate, etc. 49. Service of notices and notifications 50. Disqualification from keeping animals, veterinary medicinal products, or medicated feed, etc. 51. Forfeiture of animal, veterinary medicinal product, etc. 52. Recoupment of costs of certain disposals 53. Forgery 54. Summary proceedings 55. Fixed payment notice 56. Composite identity cards PART 3 Amendment of Fertilisers Feeding Stuffs and Mineral Mixtures Act 1955 57. Definition (Part 3) 58. Amendment of definitions in Act of 1955 59. Fertiliser and compound feeding stuff exceptions 60. Licences under section 5 of Act of 1955 61. Fertiliser registers and sales data 62. Authorised officers - Act of 1955 63. Prosecution of offences - Act of 1955 64. Penalties - Act of 1955 SCHEDULE Part 1 Routes of Retail Part 2 Symbols denoting Route of Retail Acts Referred to Animal Health and Welfare Act 2013 (No. 15) Animal Remedies Act 1993 (No. 23) Companies Act 2014 (No. 38) European Communities Act 1972 (No. 27) Fertilisers Feeding Stuffs and Mineral Mixtures Act 1955 (No. 8) Horse Racing Ireland Act 2016 (No. 2) Industrial and Provident Societies Act 1893 (56 & 57 Vict., c. 39) Irish Medicines Board (Miscellaneous Provisions) Act 2006 (No. 3) Petty Sessions (Ireland) Act 1851 (14 & 15 Vict., c. 93) Pharmacy Act 2007 (No. 20) Road Traffic Act 1961 (No. 24) Veterinary Practice Act 2005 (No. 22) Number 21 of 2023 VETERINARY MEDICINAL PRODUCTS, MEDICATED FEED AND FERTILISERS REGULATION ACT 2023 An Act to make provision for the regulation of veterinary medicinal products and medicated feed; to provide for the establishment of a national database to record veterinary prescriptions; to repeal the Animal Remedies Act 1993 ; to amend and extend the Fertilisers Feeding Stuffs and Mineral Mixtures Act 1955 ; and to provide for connected matters. [11th July, 2023] Be it enacted by the Oireachtas as follows: PART 1 Preliminary Short title, collective citation and commencement (section 7) 1. (1) This Act may be cited as the Veterinary Medicinal Products, Medicated Feed and Fertilisers Regulation Act 2023. (2) The Fertilisers Feeding Stuffs and Mineral Mixtures Act 1955 and Part 3 may be cited together as the Fertilisers Feeding Stuffs and Mineral Mixtures Acts 1955 and 2023. (3) Section 7 comes into operation on such day as the Minister may appoint by order. (4) Part 3 comes into operation on such day or days as the Minister may appoint by order or orders either generally or, in relation to the amendments to the Fertilisers Feeding Stuffs and Mineral Mixtures Act 1955 effected by that Part, with reference to any particular purpose or provision and different days may be so appointed for different purposes or different provisions. Repeals, revocation and dissolution 2. (1) The Animal Remedies Act 1993 is repealed. (2) The provisions of the following Acts are repealed: (a) section 41 of the Irish Medicines Board (Miscellaneous Provisions) Act 2006 ; (b) section 76 of the Animal Health and Welfare Act 2013 ; and (c) section 17 of the Horse Racing Ireland Act 2016 . (3) The Animal Health and Welfare (Animal Remedies Veterinary Practice and Veterinary Medicine) Regulations 2017 ( S. I. No. 558 of 2017 ) are revoked. (4) The Animal Remedies Consultative Committee is dissolved. Expenses 3. The expenses incurred by the Minister in the administration of this Act shall, to such extent as may be sanctioned by the Minister for Public Expenditure, National Development Plan Delivery and Reform, be paid out of moneys provided by the Oireachtas. PART 2 Regulation of veterinary medicinal products and medicated feed Chapter 1 Interpretation Interpretation (Part 2) 4. (1) In this Part— “Act of 2005” means the Veterinary Practice Act 2005 ; “Act of 2007” means the Pharmacy Act 2007 ; “animal” means a member of the kingdom animale other than a human being; “authorised officer” means a person appointed or deemed to be appointed as an authorised officer under section 35 ; “carcase” includes part of a carcase, whether edible or not, including blood and offal; “companion animal” means— (a) a dog or cat kept for domestic purposes only, (b) a rabbit not kept for human consumption, small rodent, cage bird or homing pigeon kept for domestic purposes, or (c) a terrarium animal or an aquarium fish kept for domestic purposes; “document” includes any book and any other record, whether legible or in a machine readable form; “export” means export from the State to another Member State or a third country; “functions” includes powers and duties; “import” means import into the State from another Member State or a third country; “medicated feed” has the meaning assigned to it by Article 3(2)(a) of the Medicated Feed Regulation; “Medicated Feed Regulation” means Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 20181 ; “Minister” means Minister for Agriculture, Food and the Marine; “national database” means the database established and maintained by the Minister under section 7 (1); “pharmacist” means a person registered as a pharmacist in the pharmacists’ register under section 14 of the Act of 2007; “sale” includes offer, expose or keep for sale, invite or offer to buy, or distribute for reward and cognate words shall be construed accordingly; “supply” includes giving without payment; “veterinarian” means a veterinary practitioner registered under Part 4 of the Act of 2005; “veterinary medicinal product” has the meaning assigned to it by Article 4(1) of the VMP Regulation; “VMP Regulation” means Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 20182 . (2) A word or expression that is used in this Part and is also used in the VMP Regulation or the Medicated Feed Regulation has, unless the contrary intention appears, the same meaning in this Part as it has in the VMP Regulation or the Medicated Feed Regulation. (3) References, after the passing of this Act, in any enactment or instrument made under an enactment to an animal remedy (within the meaning of the Animal Remedies Act 1993 ) shall be read as references to a veterinary medicinal product. Chapter 2 Veterinary medicinal products and medicated feed - prescriptions and dispensing - national database Prohibitions 5. (1) A person who is not a veterinarian shall not issue a veterinary prescription. (2) A person who issues a veterinary prescription in contravention of subsection (1) commits an offence. (3) A person who is not a veterinarian, pharmacist or person permitted under regulations made under subsection (4), shall not dispense a veterinary medicinal product subject to a prescription. (4) The Minister may by regulations permit a class of persons other than a veterinarian or pharmacist and whom he or she considers is qualified to do so to dispense a veterinary medicinal product subject to a prescription. (5) A person who dispenses a veterinary prescription in contravention of subsection (3) commits an offence. (6) A person who commits an offence under subsection (2) or (5) is liable— (a) on summary conviction, to a class A fine, or (b) on conviction on indictment, to a fine not exceeding €100,000. Prescriptions and dispensing - veterinary medicinal products, etc. 6. (1) The Minister may make regulations in relation to the prescription and dispensing of veterinary medicinal products, medicated feed or human medicinal products if prescribed for an animal or a class of animal, including, inter alia: (a) determining the maximum validity period of a prescription for a veterinary medicinal product, other than an antimicrobial; (b) specifying elements in addition to those mentioned in Article 105(5) of the VMP Regulation that a veterinary prescription shall contain; (c) determining circumstances in which a veterinary prescription may be issued or dispensed other than using the national database; (d) where a veterinary medicinal product is prescribed, specifying a category of product or a category of product listed on the national database that the Minister is satisfied that any product in that category is of sufficiently similar characteristics with the product prescribed which may be dispensed in lieu of the product; (e) dispensing of a veterinary medicinal product prescribed for an animal to which the European Union (Protection of Animals used for Scientific Purposes) Regulations 2012 ( S. I. No. 543 of 2012 ) applies by a veterinarian where the prescription for the product has been prescribed by another veterinarian; (f) requirements for the recording of prescriptions or dispensing of veterinary medicinal products or medicated feed; (g) records to be kept by persons prescribing or dispensing veterinary medicinal products or medicated feed or administering such, including the form and manner in which they are kept; (h) requirements in relation to the prescription for or dispensing of veterinary medicinal products or medicated feed which are not required to be recorded on the national database; (i) the emergency dispensing of veterinary medicinal products without prescription by a pharmacist from a retail pharmacy business (within the meaning of section 2 of the Act of 2007) in the circumstances and for the period of time specified in the regulations; (j) requirements for a proper assessment of the health status of the animal or group of animals to which the animal belongs by a veterinarian for the purposes of issuing a prescription for specified categories of veterinary medicinal products for non-therapeutic treatment. (2) A person who contravenes or fails to comply with a provision of any regulations made under subsection (1) commits an offence and is liable on summary conviction to a class A fine. (3) (a) Subject to regulations made by the Minister under paragraph (c), a veterinarian need not write a veterinary prescription in respect of a medicinal product prescribed or dispensed for, or administered to, a companion animal, if he or she offers a veterinary prescription to the owner or person in charge of the animal at the time and the offer is declined. (b) For the purposes of paragraph (a), the person in charge of a veterinary premises (within the meaning of section 105 of the Act of 2005) shall display, prominently, at the premises, signage which makes clear that a client is entitled to receive a veterinary prescription in respect of a prescription issued in respect of an animal under the care or control of the client. (c) The Minister may by regulations make requirements or provide exemptions for the purposes of paragraph (a). (d) A veterinarian who fails to comply with paragraph (a) or regulations made under paragraph (c) or a person who fails to display signage in accordance with paragraph (b) commits an offence and is liable on summary conviction to a class A fine. National database 7. (1) The Minister shall establish and maintain a database (“national database”) on which veterinary prescriptions and dispensing of veterinary prescriptions shall be recorded. (2) Subject to regulations made under section 6 (1) for the purposes of paragraph (c), a veterinary prescription shall be issued electronically and dispensed and recorded on or transmitted to the national database. (3) Subject to subsection (4), a person who issues a veterinary prescription or dispenses a medicinal product or medicated feed on foot of a veterinary prescription shall record on, or cause to be transmitted to the national database the issuing of the prescription or dispensing of the product. The format of the recording and transmission to the national database shall be in accordance with any regulations made under subsection (6). (4) The Minister shall cause to be electronically stored on the national database information obtained under subsection (2) for the purposes set out in subsection (6). (5) Information held on the national database— (a) may be shared with the following persons: (i) the Food Safety Authority of Ireland for the purpose of performing its regulatory functions; (ii) the Health Products Regulatory Authority in their role as a competent authority for the VMP Regulation; (iii) the Veterinary Council of Ireland for the purpose of performing their functions under the Act of 2005; (iv) the Pharmaceutical Society of Ireland for the purposes of performing their functions under the Act of 2007; (v) Bord Bia for the purpose of quality assurance inspections and processes; (vi) the European Commission for the purpose of audit and control; (vii) the European Court of Auditors for the purpose of audit and control; (viii) such other persons specified by the Minister in regulations where sharing such information is necessary— (I) to comply with this Part or end user obligations under the VMP Regulation or the Medicated Feed Regulation, or (II) having regard to the need to adequately safeguard public or animal health or the environment, and (b) may be accessed and used by the Minister and, subject to being required to be registered on it in accordance with regulations made under subsection (6) for the purpose of paragraph (e), the following persons: (i) veterinarians and persons engaged on their behalf for the purposes of using the national database to the extent necessary for the issuing and dispensing of veterinary prescriptions for their own clients; (ii) dispensers and persons engaged on their behalf to the extent necessary for the purposes of using the national database when dispensing a veterinary prescription; (iii) keepers and owners of animals subject to a veterinary prescription to the extent necessary for animals under their care; (iv) such other persons specified by the Minister in regulations where accessing such information is necessary— (I) to comply with this Part or end user obligations under the VMP Regulation or the Medicated Feed Regulation, or (II) having regard to the need to adequately safeguard public or animal health or the environment. (6) The Minister may make regulations in relation to the operation of the national database including, inter alia— (a) specifying the information to be recorded on and the manner, method or form of recording information on or transmitting it to, the national database, (b) determining the form of an electronic prescription or notification of the existence of a prescription on the national database, (c) if recorded on another database, requiring that the information is transmitted to and from the national database in a readable and compatible form as specified in the regulations, (d) specifying the period of time within which such prescriptions or dispensing must be recorded or shared with the national database, (e) providing for the registration on the national database of a person referred to in subparagraph (i), (ii), (iii) or (iv) of paragraph (b) of subsection (5) to access and use it, and (f) providing for the prescription and dispensing protocols in circumstances as determined by the Minister where the national database is unavailable to users. (7) The Minister may process information held on the national database for the following: (a) monitoring, evaluating or reporting the volume of sales, level and frequency of use of veterinary medicinal products or medicated feed or certain classes of such, or in specific animals or in different species of animals in the State; (b) developing or implementing national or European policy relating to the use of veterinary medicinal products or medicated feed or certain classes of such in specific animals or in different species of animals in the State; (c) determining the types of diseases or ailments in respect of which specific types of veterinary medicinal products or medicated feed are prescribed or dispensed; (d) evaluating or determining the persons or class of persons prescribing, dispensing or using veterinary medicinal products or medicated feed or certain classes of such in the State and the level and frequency of prescribing, dispensing or use by such persons; (e) monitoring or evaluating the scientific justification provided for prescribing veterinary medicinal products or medicated feed or certain classes of such for use in specific animals or in different species of animals; (f) evaluating or identifying if certain locations in the State are more prevalent to animal diseases or ailments; (g) the administration, control and enforcement of this Part, the VMP Regulation, the Medicated Feed Regulation or Regulation 625/2017 of the European Parliament and of the Council of 15 March 20173 ; (h) where processing such information is necessary— (i) to comply with this Part or end user obligations under the VMP Regulation or the Medicated Feed Regulation, or (ii) having regard to the need to adequately safeguard public or animal health or the environment. (8) A person who fails to comply with subsection (2) or (3) commits an offence and is liable on summary conviction to a class A fine. Prescriptions under Article 105 of VMP Regulation and Article 16 of Medicated Feed Regulation 8. (1) A veterinary prescription issued under Article 105 of the VMP Regulation or Article 16 of the Medicated Feed Regulation shall be issued in such form as prescribed, electronically or on paper, for a prescribed class or classes of animals in regulations made by the Minister. (2) A medicinal product prescribed under Article 105 of the VMP Regulation or Article 16 of the Medicated Feed Regulation shall not be supplied unless the prescription has been issued electronically or in such other manner as prescribed in regulations made by the Minister. (3) A person who fails to comply with subsection (1) or (2) commits an offence and is liable on summary conviction to a class A fine. Chapter 3 Rules on retail Purpose of Chapter 3 9. The purpose of this Chapter is to determine the rules on retail as required under Article 103(1) of the VMP Regulation unless otherwise provided in that Article. Definitions (Chapter 3) 10. In this Chapter— “manufacturing authorisation” means a manufacturing authorisation granted under Chapter VI of the VMP Regulation; “marketing authorisation” means a marketing authorisation granted under Chapter II of the VMP Regulation; “pharmacy” means a retail pharmacy business within the meaning of the Act of 2007; “Register” means the Companion Animal Medicine Retailers’ Register established under section 21 ; “Regulations of 2007” means European Communities (Animal Remedies) (No. 2) Regulations 2007 ( S. I. No. 786 of 2007 ); “retail” includes sell or supply; “retail responsible person” means a person deemed as such under section 20; “retailer’s licence” means a veterinary medicinal product retailer’s licence granted under section 18 ; “route of retail” means the person who may retail a veterinary medicinal product and the manner of its retail from the options set out in Part 1 of the Schedule and designated in the terms of the marketing authorisation relating to the product; “special import licence” means a licence granted under section 25 (1); “veterinary nurse” means a veterinary nurse registered under Part 8 of the Act of 2005; “wholesale distribution authorisation” means a wholesale distribution authorisation granted under Article 100 of the VMP Regulation. Route of retail 11. (1) The routes of retail for veterinary medicinal products which may be designated in the terms of a marketing authorisation are from the options set out in Part 1 of the Schedule and the symbols that may be used denoting them are set out in Part 2 of the Schedule . (2) A competent authority, where it grants a marketing authorisation, shall— (a) as a condition of authorisation of a veterinary medicinal product, designate the route of retail for the product from the options set out in paragraph 1, 2, 3 or 4 of Part 1 of the Schedule , and (b) specify that the route of retail designated shall appear in the package leaflet or on the packaging relating to the product. (3) Notwithstanding subsections (1) and (2), a veterinary medicinal product designated “not subject to a prescription” by the European Commission may be retailed: (a) by a pharmacist or a retail responsible person from a pharmacy; (b) by a veterinarian where the animal to which the product is to be administered is under his or her care; (c) from a premises to which a retailer’s licence relates; or (d) in the case of companion animal medicine, from the premises of a person entered in the Register. Restriction on retail of veterinary medicinal products 12. (1) A person shall not retail a veterinary medicinal product except in accordance with the route of retail designated under section 11 in the terms of the marketing authorisation relating to the product. (2) The Minister may make regulations specifying the categories of veterinary medicinal products designated “prescription only” under paragraph 1 or “prescription only exempt” under paragraph 2 of Part 1 of the Schedule that a retail responsible person may retail. (3) A person shall not, unless authorised by the relevant competent authority, possess or retail a veterinary medicinal product if the label or package leaflet as required under section 13 , relating to the product has been altered or removed. (4) A person who fails to comply with subsection (1) commits an offence and is liable— (a) on summary conviction, to a class A fine, or (b) on conviction on indictment, to a fine not exceeding €300,000. (5) A person who fails to comply with subsection (3) commits an offence and is liable— (a) on summary conviction, to a class A fine, or (b) on conviction on indictment, to a fine not exceeding €25,000. Labelling of veterinary medicinal products 13. (1) A veterinarian, or a person who retails a veterinary medicinal product designated under paragraph 1 of Part 1 of the Schedule to be “prescription only” shall, subject to subsection (2), affix to the packaging of the product, at the time of retail, in a manner that does not obscure the information required by its marketing authorisation, a label mentioning at least the following in relation to the product: (a) supplier information; (b) prescription identification information; (c) details of the prescribing veterinarian; (d) the date of retail; (e) the dosage and duration of treatment (unless indicated on a proprietary label); (f) withdrawal period (unless indicated on a proprietary label); (g) special import licence information, if applicable; and (h) any other information specified in regulations made by the Minister necessary to safeguard public and animal health and the environment. (2) If the packaging of a veterinary medicinal product is not large enough to affix a label to it, a label containing the information required under subsection (1) may be affixed to the outer package of the product when dispensed. (3) A person who fails to comply with subsection (1) commits an offence and is liable on summary conviction to a class A fine. Prohibition on retail of veterinary medicinal product after expiry date 14. (1) A person shall not retail a veterinary medicinal product after the date specified by the manufacturer as the expiry date. (2) A person who fails to comply with subsection (1) commits an offence and is liable on summary conviction to a class A fine. Exemption from manufacturing authorisation 15. A manufacturing authorisation shall not be required for— (a) at the time of sale, the dividing of or changes in outer packaging of veterinary medicinal products, where the quantity to be supplied is less than that available in the smallest proprietary pack size and, where those processes are carried out by a pharmacist, veterinarian or for certain categories of veterinary medicinal products other persons specified by the Minister in regulations, solely for retail directly to the public, or (b) the extemporaneous preparation, in accordance with Article 112, 113 or 114 of the VMP Regulation, of a veterinary medicinal product or magistral formula (provided it is not prepared in advance) by— (i) a veterinarian for the treatment of an animal under his or her care, or (ii) a pharmacist for the purposes of dispensing a veterinary medicinal product in accordance with a veterinary prescription. Labelling veterinary medicinal products retailed out of their original outer packaging 16. (1) A person who retails a veterinary medicinal product that has been divided and is not in its original outer packaging shall— (a) provide a copy of the original data sheet in respect of the product supplied by the manufacturer with the product, or (b) label the product or ensure that it is labelled when retailed, with at least the following information: (i) the proprietary name of the product; (ii) the words “for animal treatment only”; (iii) the species to be treated; (iv) the manner of administration; (v) the dosage and duration of treatment; (vi) the name of the person to whom the product is retailed; (vii) the name and business address of the retailer; (viii) precautions regarding administration of the product and any withdrawal period; (ix) if applicable, special import licence information; and (x) any other information specified in regulations made by the Minister necessary to safeguard public and animal health and the environment. (2) A person who fails to comply with subsection (1) commits an offence and is liable on summary conviction to a class A fine. Restriction on use of premises 17. (1) A person shall not use a premises to store a veterinary medicinal product for the purpose of retail unless the premises is— (a) a premises in respect of which a retailer’s licence relates, (b) a premises owned or operated by a person entered in the Register, (c) a pharmacy, or (d) a premises to which a certificate of suitability granted under section 109 of the Act of 2005 applies. (2) The Minister may by regulations specify the conditions and circumstances within which a premises referred to in subsection (1) may be used to store a veterinary medicinal product for the purpose of retail having regard to the need to adequately safeguard public and animal health and the environment. (3) A person who fails to comply with subsection (1) or regulations made under subsection (2) commits an offence and is liable on summary conviction to a class A fine. Veterinary medicinal product retailer’s licence 18. (1) The Minister may on application grant a licence, to be known as a veterinary medicinal product retailer’s licence, and in this Chapter referred to as a retailer’s licence to a person, where he or she is satisfied that the applicant for the licence has suitable premises, equipment and staff and suitable arrangements for record-keeping, handling, storage, dispensing and retail of a veterinary medicinal product or class of veterinary medicinal product, to retail the veterinary medicinal product from those premises. The Minister may issue guidelines as to that which he or she considers to be suitable for the purposes of an application under this subsection. (2) A retailer’s licence— (a) relates to the premises specified in the licence, and (b) remains in force while the holder satisfies the conditions of the grant of the licence, but does not entitle the holder of the licence to retail a veterinary medicinal product from a premises the subject of a wholesale distribution authorisation. (3) A person, other than a veterinarian supplying their own clients or a pharmacist from a pharmacy shall not retail a veterinary medicinal product from a premises unless the person holds a retailer’s licence to retail the product from premises mentioned in the licence. (4) A person who fails to comply with subsection (3) commits an offence and is liable— (a) on summary conviction, to a class A fine, or (b) on conviction on indictment, to a fine not exceeding €300,000. (5) (a) The holder of a retailer’s licence shall— (i) have at his or her disposal, during hours of retail, the services of at least one retail responsible person for the purposes of selling veterinary medicinal products, and (ii) ensure that a veterinary medicinal product, other than a companion animal medicine, is not retailed from the premises of the holder other than by a retail responsible person. (b) A person who fails to comply with this subsection commits an offence and is liable on summary conviction to a class A fine. (6) A retailer’s licence may apply to veterinary medicinal products generally, to veterinary medicinal products of a particular class or description, or to one or more veterinary medicinal products, specified in the licence. (7) Subsection (3) does not apply to a veterinarian who retails a veterinary medicinal product designated under paragraph 4 of Part 1 of the Schedule to be a “companion animal medicine”. (8) The holder of an animal remedies merchant’s licence granted under Regulation 31 of the Regulations of 2007 which was in force on 27 January 2022 is deemed to have continued in force after that day and, if in force on the passing of this Act, to be the holder of a retailer’s licence under this Regulation. Obligations of holder of retailer’s licence 19. (1) The holder of a retailer’s licence shall obtain a veterinary medicinal product only from a holder of a wholesale distribution authorisation authorised to distribute veterinary medicinal products or a holder of a manufacturing authorisation authorised to manufacture the product. (2) A person who fails to comply with subsection (1) commits an offence and is liable on summary conviction to a class A fine. (3) The holder of a retailer’s licence when retailing a veterinary medicinal product shall— (a) ensure that a retail responsible person provides advice to the end user on the appropriate storage, administration, contraindications, withdrawal period, disposal of the veterinary medicinal product and procedures for reporting suspected adverse events, (b) ensure that a retail responsible person obtains the consent of the end user before dispensing to him or her a product in accordance with regulations made for the purposes of section 6 (1)(d) and shall ensure the end user is fully advised of any product differences to the prescribed product including withdrawal periods, (c) not retail the product except to an end user of the product or a veterinarian in small quantities, in accordance with Article 99 of the VMP Regulation, (d) comply with any advertising requirements of Section 4 of Chapter VII of the VMP Regulation or guidance provided by the Minister in relation to veterinary medicinal products, (e) provide and maintain premises, equipment and staff and have in operation arrangements necessary to avoid deterioration of the product and to notify the Minister within 7 days of a material change in the premises, equipment, staff or arrangements of the holder, (f) permit inspections by authorised officers and make available information required to satisfy the Minister that the conditions of the licence are being complied with, (g) immediately withdraw, if directed by the Minister, the European Medicines Agency, the Health Products Regulatory Authority, the marketing authorisation holder or the wholesale distribution authorisation holder, from retail any quantity, and, in so far as is practicable, immediately recall any quantity sold or supplied of— (i) a batch or part of a batch of a product that does not conform with a marketing authorisation or the strength, quality or purity does not conform with the specification of that veterinary medicinal product, or (ii) a product that has given rise to unacceptable adverse events, unacceptable environmental safety or consumer safety concerns or a negative benefit or risk balance as decided by the person so directing, (h) report any suspected adverse events as defined in Article 73(2) of the VMP Regulation, that they are made aware of, to the marketing authorisation holder of the veterinary medicinal product or the competent authority concerned designated under Article 137 of the VMP Regulation, (i) have in place the necessary systems to receive from those that they retail to, the veterinary medicinal product that is unused or expired for the return to the person from whom they purchased that product and in addition take steps to ensure that customers are aware of the arrangements, (j) ensure the premises of the holder and the retail and storage of veterinary medicinal products conform with the conditions in the holder’s licence, (k) in addition to keeping records of veterinary medicinal products requiring a veterinary prescription, keep records of such products not subject to veterinary prescription, and (l) comply with such further obligations specified in regulations by the Minister having regard in particular to the need to adequately safeguard public and animal health. (4) Where the Minister considers that the holder of a retailer’s licence is not complying with the obligations of a holder under subsection (3), the Minister shall notify the holder of this and require the holder to comply with the obligation in accordance with the notification within such time as specified in the notification. If the holder of the licence does not comply with the notification or does not comply with it to the satisfaction of the Minister, the Minister may withdraw the licence indefinitely or until the holder complies with the notification and section 34 (6) applies to any proposed withdrawal. Training 20. (1) A person, other than a veterinarian, veterinary nurse or pharmacist, shall undergo a training course of a standard approved of by the Minister, including at appropriate intervals, in the proper and safe handling and storage of veterinary medicinal products to be responsible for the retail of such veterinary medicinal products. (2) For the purpose of subsection (1), where a person has undergone a training course or training before the passing of this Act which is of a standard approved by the Minister under subsection (1), this section applies. (3) The Minister may require persons to undergo continual training in the proper and safe handling and storage of veterinary medicinal products to be responsible for the retail of such products, and upon request, furnish to the Minister satisfactory evidence that they have successfully completed the training. (4) A person who has undertaken a course of training in accordance with subsection (1), shall, upon request, furnish to the Minister, where he or she is issuing a certificate under subsection (5), satisfactory evidence that he or she has successfully completed the course. (5) Where, in the opinion of the Minister, a person, has successfully completed a training course under subsection (1), the Minister, or, if permitted by him or her, the person who provided the training course, shall issue the person with a certificate for the retail of veterinary medicinal products and the person is referred to in this Chapter as a “retail responsible person”. (6) The Minister may require a retail responsible person to undergo additional training, if the Minister considers it necessary. (7) The Minister may refuse or direct a person providing a training course to refuse to certify a person to be a retail responsible person if, notwithstanding that the person has successfully completed an approved training course, the person has been convicted of an offence under this Part or the VMP Regulation or Medicated Feed Regulation. (8) The Minister may withdraw the certification of a retail responsible person if, upon inspection, it is found that the person has been convicted of an offence under this Part or the VMP Regulation or Medicated Feed Regulation or is not retailing veterinary medicinal products in accordance with the certification. (9) (a) Where the Minister proposes to withdraw certification from a person as a retail responsible person, the Minister shall notify the person of the proposal. The person may, within such period as the Minister allows in the notification, being not less than 14 days, make representations in writing to the Minister in relation to the proposal. The Minister, where no representations are made within that period, or where representations are so made and having considered the representations, may withdraw the certification or let the certification stand with or without conditions and notify the person of the decision. (b) If the decision is to withdraw certification, the person may within 14 days of being notified of the decision, appeal to a judge of the District Court in whose district he or she carries on the business of the retail of veterinary medicinal products. On hearing the appeal, the judge may confirm the decision of the Minister or allow the appeal. The decision of the court is final save that an appeal on a point of law lies to the High Court. (c) A decision of the Minister to withdraw certification takes effect on the notification of the decision to the person. The person, if making an appeal under paragraph (b), may apply to the court where the appeal is lodged to have the decision suspended until the appeal is determined or withdrawn. Companion animal medicine retailers’ register 21. (1) The Minister shall establish and maintain a register of retailers of veterinary medicinal products for companion animals designated “companion animal medicine” under paragraph 4 of Part 1 of the Schedule to be known as the Companion Animal Medicine Retailers’ Register and in this Chapter referred to as “the Register”. (2) A person retailing or intending to retail veterinary medicinal products designated companion animal medicines may apply to the Minister to be entered on the Register. (3) An application for entry in the Register shall be— (a) in such form and manner as the Minister decides, and (b) accompanied by such non-refundable fee as the Minister specifies in regulations. (4) A person who, when applying for registration in the Register, furnishes information to the Minister knowing it to be false or misleading in any material respect commits an offence and shall be liable on summary conviction to a class A fine. (5) (a) A person shall not retail a veterinary medicinal product designated companion animal medicine except from premises of a person registered in the Register. (b) A person who fails to comply with this subsection commits an offence and is liable on summary conviction to a class A fine. (6) (a) The Minister may require a person entered in the Register to undergo or to ensure that an employee of the person undergoes training that the Minister considers to be adequate in the proper and safe handling and storage of veterinary medicinal products so they are responsible for the retail of such veterinary medicinal products. (b) A person entered in the Register who fails to comply with a requirement of the Minister under this subsection may be removed by the Minister from the Register in accordance with subsection (9). (7) A person registered in the Register shall comply with the storage requirements for a veterinary medicinal product specified in the labelling and packaging leaflet accompanying the product. (8) This section does not apply to: (a) a veterinarian; (b) a veterinary nurse; (c) a pharmacist; (d) the holder of a retailer’s licence; or (e) the holder of a wholesale distribution authorisation. (9) (a) The Minister— (i) where he or she considers that an applicant for registration in the Register should not be entered in the Register or a person entered in the Register is not complying with this section, may remove the person from the Register, (ii) if considering refusing an application for registration in or the removal of a person from the Register, notify the person of the proposal. The notification shall allow the person to make representations to the Minister against the proposal within such period as the Minister allows in the notification, being not less than 14 days, of the person being notified, and (iii) where no representations are made within that period, or where representations are so made and having considered the representations, may enter the person in the Register, refuse the application or remove the person from the Register and notify the person of his or her decision. (b) If the decision is to refuse an application for registration in, or remove the person from, the Register, the person may, within 14 days of being notified, appeal to a judge of the District Court in whose district he or she carries on the business of the retail of veterinary medicinal products. On hearing the appeal, the judge may confirm the refusal for registration in or removal of the person from the Register or allow the appeal. The decision of the court is final save that an appeal on a point of law lies to the High Court. (c) A decision of the Minister to remove the person from the Register takes effect on the date of notification of the decision to the person. The person, if making an appeal under paragraph (b), may apply to the court where the appeal is lodged to have the decision suspended until the appeal is determined or withdrawn. (10) A person entered in the Register maintained under Regulation 33 of the Regulations of 2007 on 27 January 2022 is deemed to be entered in the Register. Record-keeping for veterinarian, pharmacist and retailer’s licence holder 22. (1) A veterinarian, pharmacist or the holder of a retailer’s licence shall, in addition to the records to be kept in accordance with Article 103(3) of the VMP Regulation, keep detailed records of any transaction of veterinary medicinal products not subject to a prescription, other than those with the route of retail designated companion animal medicine. (2) A person who fails to comply with subsection (1) commits an offence and is liable on summary conviction to a class A fine. Fixed premises 23. (1) A person shall not retail a veterinary medicinal product other than from a fixed premises. (2) Subsection (1) does not apply to the retail of a veterinary medicinal product in the course of the provision of a veterinary service by a veterinarian for the treatment of an animal under his or her care. (3) A person shall not, other than under and in accordance with a licence granted by the Minister on application made to him or her in that behalf, make a visit from house to house to collect, solicit or obtain an order for a veterinary medicinal product. (4) Subsection (3) does not apply in the case of a visit made by the representative or agent of a wholesale distribution authorisation holder or marketing authorisation holder to any of the following persons at his or her place of business: (a) a veterinarian; (b) a pharmacist; (c) the holder of a retailer’s licence; or (d) a person registered in the Register. (5) The Minister shall not grant a licence under subsection (3) unless the applicant is— (a) the holder of a retailer’s licence, or (b) a pharmacist. (6) A licence granted under subsection (3) may only relate to a veterinary medicinal product that may be retailed as a condition of a marketing authorisation as referred to in paragraph 3 or 4 of Part 1 of the Schedule . (7) A person who fails to comply with subsection (1) or (3) commits an offence and is liable— (a) on summary conviction, to a class A fine, or (b) on conviction on indictment, to a fine not exceeding €100,000. (8) The holder of a licence granted under Regulation 36(3)(b) of the Regulations of 2007 which was in force on 27 January 2022 is deemed to have continued in force after that day and, if in force on the passing of this Act, to be the holder of a licence under this Regulation. (9) In this section— “fixed premises” does not include a vehicle, trailer, caravan, or other thing which may be transported on, in or attached to a vehicle or a tent, awning, hut, shed or an unroofed or temporary structure or stall or a yard, field, roadway or casual trading area; “house” includes land or other premises. Retail at distance 24. (1) A person shall not retail to another person in another Member State or a third country a veterinary medicinal product subject to a veterinary prescription at a distance. (2) A person shall not purchase from another person in another Member State or a third country a veterinary medicinal product subject to a prescription at a distance, unless the product is purchased in accordance with procedures as laid out by the competent authority concerned as permitted by Article 106(3) of the VMP Regulation. (3) A person shall not purchase from another person in a third country a veterinary medicinal product not subject to a prescription at a distance, unless in accordance with procedures as laid out by the competent authority concerned as permitted by Article 106(3) of the VMP Regulation. (4) A person who fails to comply with subsection (1), (2) or (3) commits an offence and is liable— (a) on summary conviction, to a class A fine, or (b) on conviction on indictment, to a fine not exceeding €100,000. (5) A person who holds a licence under subsection (8) may retail to a person over the internet such veterinary medicinal products as permitted under the licence or under regulations made by the Minister under this subsection, if the person is permitted under the licence to retail the product. (6) A person shall not retail over the internet a veterinary medicinal product unless the person holds a licence under subsection (8) to retail the product. (7) A person who fails to comply with subsection (6) commits an offence and is liable— (a) on summary conviction, to a class A fine, or (b) on conviction on indictment, to a fine not exceeding €100,000. (8) The Minister may grant a licence to: (a) the holder of a retailer’s licence; (b) a pharmacist; (c) a veterinarian supplying his or her own clients; or (d) a person registered in the Register, in accordance with any regulations made under subsection (5) and specifying the categories of veterinary medicinal products that may be retailed over the internet under the licence. (9) A person who holds a licence under subsection (8) and retails over the internet other than in accordance with the licence commits an offence and is liable— (a) on summary conviction, to a class A fine, or (b) on conviction on indictment, to a fine not exceeding €50,000. (10) The holder of a licence granted under Regulation 36(3)(a) of the Regulations of 2007 which was in force on 27 January 2022 is deemed to have continued in force after that day and, if in force on the passing of this Act, to be the holder of a licence under this section and has effect accordingly. Licencing of import of medicinal products in relation to their use under Articles 110 to 114 or 116 of VMP Regulation 25. (1) The Minister may, on application, authorise in accordance with Article 106(3) of the VMP Regulation by licence, to be known as a special import licence, or notification to be known as a special import notification, the import, possession, retail or use of a veterinary medicinal product for the purposes of Article 110 or 116, or a medicinal product for the purposes of Article 111, 112, 113 or 114, of the VMP Regulation by— (a) a veterinarian, (b) the holder of a wholesale distribution authorisation, or (c) the holder of a marketing authorisation. (2) A person who imports, possesses, retails or uses a medicinal product— (a) for the purposes of Article 110 or 116 of the VMP Regulation, or (b) for the purposes of Article 112, 113 or 114 of the VMP Regulation, that has not been granted a marketing authorisation by the competent authority or the European Commission, without holding a special import licence or notification commits an offence and is liable— (i) on summary conviction, to a class A fine, or (ii) on conviction on indictment, to a fine not exceeding €300,000. (3) The Minister may make regulations as permitted by Article 106(3) of the VMP Regulation on procedures required for the implementation of Articles 110 to 114 and 116. Regulations - rules on retail 26. (1) The Minister may make regulations in relation to the retail, importation or exportation of veterinary medicinal products, ingredients for such or medicated feed, generally or by such class of persons as specified in the regulations, including— (a) prohibiting or restricting the retail, importation or exportation of a veterinary medicinal product or an ingredient thereof or medicated feed or a category of such, (b) prohibiting or restricting the retail, importation or exportation of an animal or carcase of an animal to which a specified a veterinary medicinal product or an ingredient thereof has been administered or a specified medicated feed has been fed, or (c) imposing prohibitions, restrictions or conditions on their retail, importation or exportation or possession justified on grounds of protection of public and animal health or of the environment. (2) A person who contravenes or fails to comply with a provision of any regulations made under subsection (1) which is stated in the regulations to be a penal provision— (a) to which this paragraph applies, commits an offence and is liable on summary conviction to a class A fine, or (b) to which this paragraph applies, commits an offence and is liable— (i) on summary conviction, to a class A fine, or (ii) on conviction on indictment, to a fine not exceeding €100,000. Chapter 4 Control of possession and administration of veterinary medicinal products or medicated feed Prohibition on possession of veterinary medicinal products or medicated feed 27. (1) The Minister may by regulations prohibit or restrict the possession or control of specified veterinary medicinal products or ingredients thereof or medicated feed, generally or by such persons specified in the regulations. (2) A person who has in his or her possession or under his or her control a veterinary medicinal product or an ingredient thereof or medicated feed which is prohibited or restricted under regulations made under subsection (1) commits an offence. (3) A person who sells or supplies to another person a veterinary medicinal product or an ingredient thereof or medicated feed which the other person is prohibited from possessing or having control of under regulations made under subsection (1) commits an offence. It is a defence for a person accused of contravening this subsection to show he or she was unaware that the other person was so prohibited or restricted and being so unaware was reasonable in the circumstances. (4) A person who has in his or her possession or under his or her control— (a) a veterinary medicinal product or an ingredient thereof or medicated feed for the purpose of selling or otherwise supplying or exporting it to another person, or (b) an animal or the carcase of an animal knowing, or in the circumstances ought to know, it to be an animal or carcase to which a veterinary medicinal product or an ingredient has been administered or medicated feed has been fed for the purpose of— (i) selling or otherwise supplying or exporting the animal or any produce for human consumption which is derived in whole or in part from the animal or carcase to another person, or (ii) slaughtering the animal for human consumption, where such sale or supply or exportation would be in contravention of regulations under section 26 (1)(a), (b) or (c) commits an offence. (5) A person who commits an offence under this section is liable— (a) on summary conviction, to a class A fine, or to imprisonment for a term not exceeding 6 months, or to both, or (b) on conviction on indictment, to a fine not exceeding €300,000, or to imprisonment for a term not exceeding 2 years, or to both. (6) In this section, “human consumption” includes intended for incorporation in, or manufacture into, a food intended for human consumption. Administration of veterinary medicinal products or medicated feed 28. (1) The Minister may by regulations prohibit or restrict a person, other than a veterinarian, to administer to an animal a specified veterinary medicinal product or an ingredient thereof. (2) A person who contravenes regulations made under subsection (1), or directs another to so contravene, commits an offence and is liable— (a) on summary conviction, to a class A fine, or to imprisonment for a term not exceeding 6 months, or to both, or (b) on conviction on indictment, to a fine not exceeding €300,000, or to imprisonment for a term not exceeding 2 years, or to both. (3) The Minister may make regulations governing the administration or use of veterinary medicinal products or medicated feed generally or by a specified class of persons. (4) A person who contravenes regulations made under subsection (3) commits an offence and is liable on summary conviction to a class A fine. Chapter 5 Storage, advertising and licensing certain veterinary medicinal products, etc. Regulations - secure storage, etc. of veterinary medicinal products 29. (1) The Minister may make regulations— (a) specifying precautions to be taken for the purpose of ensuring the secure storage of veterinary medicinal products, (b) in relation to the storage or handling of veterinary medicinal products, or (c) requiring that stored veterinary medicinal products which, because of their condition, the period within which they may be used has expired or for any other reason, are not intended to be used shall be destroyed or disposed of in a specified manner. (2) A person who fails to comply with a provision of any regulations made under this section commits an offence and is liable on summary conviction to a class A fine. (3) The Minister may approve or establish training courses in respect of the proper and safe handling and secure storage of veterinary medicinal products. Advertising of veterinary medicinal products or medicated feed 30. (1) The Minister may make regulations for the advertising or promoting of veterinary medicinal products or medicated feed, including imposing prohibitions, restrictions or conditions on providing such. (2) Regulations under this section may in particular provide for— (a) as permitted under Article 119(1), deciding to allow the advertisement of veterinary medicinal products not authorised or registered in the State in accordance with specified conditions, (b) permitting the advertising of veterinary medicinal products that are subject to veterinary prescription referred to in Article 120(2) to professional keepers of animals, by way of derogation under paragraph (2) from paragraph (1) of Article 120, or (c) as permitted under Article 122, establishing procedures the Minister considers necessary for the implementation of Articles 119, 120 and 121, of the VMP Regulation. (3) A person who fails to comply with a provision of any regulations made under this section which is stated in the regulations to be a penal provision to which this subsection applies commits an offence and is liable on summary conviction to a class A fine. Licence required for certain activities 31. (1) The Minister, upon application to him or her, may permit by licence— (a) the manufacture, import or export of autogenous vaccines, (b) the collection storage and supply of blood, or the storage and supply of blood constituents obtained by the phys …