Veterinary Medicinal Products, Medicated Feed and Fertilisers Regulation Act 2023

PART 1 Preliminary

1. 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.

2. 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 (1) The Animal Remedies Act 1993 is repealed.

(2) The provisions of the following Acts are repealed: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.

3. 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

4. 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 2018[^1];

“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 2018[^2].

(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

5. 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.

6. 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.

7. 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 ofparagraph (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 2017[^3];

(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.

8. 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

9. 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.

10. 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.

11. 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.