Veterinary Medicinal Products, Medicated Feed and Fertilisers Regulation Act 2023

Type Act
Publication 2023-07-11
State In force
Text As published
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articles 64

This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.

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.

Reform history JSON API

“Authorised officers - inspection and taking samples

  1. (1) The Minister may for the purpose of enforcing this Act appoint in writing such persons or classes of persons as he or she considers appropriate to be authorised officers for the exercise of all or any of the functions conferred on an authorised officer under this Act.

  2. (2) An authorised officer may at all reasonable times enter and inspect any land or premises, railway wagon, vehicle, ship, vessel or aircraft in which he or she has reasonable grounds for believing that any fertiliser, feeding stuff, compound feeding stuff or mineral mixture is manufactured for sale, kept or carried for sale or sold, or a document or record related to a fertiliser, feeding stuff, compound feeding stuff or mineral mixture is kept or any equipment or machinery relating to such, and may—

    • (a) examine and take samples and stock of any fertilisers, feeding stuffs, compound feeding stuffs or mineral mixtures, or of any materials capable of being used in the manufacture of fertilisers, feeding stuffs, compound feeding stuffs or mineral mixtures, which he or she finds in the course of his inspection,

    • (b) examine a document or record related to a fertiliser, feeding stuff, compound feeding stuff or mineral mixture, equipment, machinery or other thing used in connection with a fertiliser, feeding stuff, compound feeding stuff or mineral mixture,

    • (c) require the name and address of the owner, or person in possession or control of a document or record related to a fertiliser, feeding stuff, compound feeding stuff or mineral mixture, equipment, machinery, a vehicle or a vessel used in connection with a fertiliser, feeding stuff, compound feeding stuff or mineral mixture or require details of place of departure, journey or destination,

    • (d) inspect a vehicle, a vessel, an aircraft, a railway wagon, a container, equipment, machinery, a computerised information management system or other thing used in connection with a document or record related to a fertiliser, feeding stuff, compound feeding stuff or mineral mixture and require the person in charge or control of such to refrain from moving it,

    • (e) require the owner, person in possession or control of any premises, equipment, machinery, a computerised information management system, a vehicle, a vessel or other thing used in connection with a document or record related to a fertiliser, feeding stuff, compound feeding stuff or mineral mixture, to produce to the officer such records (and in the case of a record stored in non-legible form, produce to him or her a copy in a legible form) that are in the person’s possession or procurement, or under the person’s control, as the officer may reasonably require,

    • (f) inspect and take copies of any record (including a legible reproduction of one stored in non-legible form) or extracts from the record that the officer finds or is produced to him or her during an inspection, or

    • (g) make a record, including by means of writing, sound recording, photograph, video or other means.

  3. (3) An authorised officer may require a person to give information regarding the ownership and identity of a document or record related to a fertiliser, feeding stuff, compound feeding stuff or mineral mixture, equipment, machinery, a vehicle, a vessel or other thing used in connection with a document or record related to a fertiliser, feeding stuff, compound feeding stuff or mineral mixture as is in the person’s knowledge or procurement.

  4. (4) Where an authorised officer has reasonable grounds for believing that—

    • (a) an offence is being or has been committed under this Act, or

    • (b) evidence of an offence to which paragraph (a) relates may be, is or has been on any land or premises, or in a vehicle, a vessel, an aircraft, a railway wagon, a container, equipment or machinery,

    the officer may, in addition to the powers exercisable by him or her under subsection (1):

    - (i) search the land or premises;
    
    - (ii) search the vehicle, vessel, aircraft, railway wagon, container, equipment or machinery (including any computerised information management system);
    
    - (iii) require a person in charge or control of the vehicle, vessel, aircraft, railway wagon, container, equipment or machinery to—
    
        - (I) refrain from moving it, or move it to a location where it may be searched,
    
        - (II) give information regarding its place of departure, journey or destination, and
    
        - (III) where the equipment or machinery is part of a computerised information management system, provide assistance (including providing passwords) to enable access to such devices or systems;
    
    - (iv) seize and detain a document or record related to a fertiliser, feeding stuff, compound feeding stuff or mineral mixture and mark or otherwise identify it;
    
    - (v) detain a vehicle, vessel, aircraft, railway wagon, equipment, machinery (including any computerised information management system) or container for such reasonable period necessary for the purposes of permitting an inspection or a search under this section either at the place where it was first detained or require it to be moved to such other location as the authorised officer requires;
    
    - (vi) remove any equipment, machinery (including any computerised information management system), books, documents or records and detain them for such reasonable period necessary for the purpose of his or her functions under this Act;
    
    - (vii) give such direction to a person who has a document or record related to a fertiliser, feeding stuff, compound feeding stuff or mineral mixture, or who has equipment, machinery, vehicle or vessel or other thing used in connection with a document or record related to a fertiliser, feeding stuff, compound feeding stuff or mineral mixture in his or her possession or under his or her control or who has information relating to such, as the authorised officer may reasonably consider necessary for the purposes of this Act.
    
  5. (5) An authorised officer shall not enter, except with the consent of the occupier, a private dwelling unless he or she has obtained a search warrant under section 8A other than where he or she has reasonable grounds for believing that before a search warrant could be sought in relation to the dwelling under section 8A, any evidence of an offence referred to in subsection (4)(a) is being or is likely to be disposed of or destroyed.

  6. (6) An authorised officer, when exercising a function under this Act, may be accompanied by other persons and may take with him or her, or those persons may take with them, any equipment or materials to assist the officer in the exercise of the function.

  7. (7) An authorised officer may use reasonable force, if necessary, to exercise his or her functions under this Act.

  8. (8) Where, in the course of exercising a function under this Act, an authorised officer finds or comes into possession of anything that the officer has reasonable grounds for believing to be evidence of an offence or suspected offence under this Act, the officer may seize and retain it for use in evidence in proceedings for an offence under this Act.

  9. (9) An authorised officer may only stop a vehicle for the purposes of subsection (4) in a public place (within the meaning of the Road Traffic Act 1961) if accompanied by a member of the Garda Síochána and the officer requests the member to stop the vehicle.

  10. (10) A member of the Garda Síochána may stop a vehicle or vessel, for the purposes of this Act and may require it to be moved for inspection to such place as he or she directs.

  11. (11) A person who has—

    • (a) a document or record related to a fertiliser, feeding stuff, compound feeding stuff or mineral mixture, or

    • (b) equipment, machinery, a vehicle, a vessel or other thing used in connection with a document or record related to a fertiliser, feeding stuff, compound feeding stuff or mineral mixture,

    in his or her possession or under his or her control, or information or a record relating to any of them, shall give such—

    - (i) assistance to an authorised officer, or person who accompanies the officer, and
    
    - (ii) information to an authorised officer on request being made, in that behalf by the officer, as the officer may reasonably require for the exercise of his or her functions under this Act.
    
  12. (12) The owner or person in charge of any premises used in connection with a document or record related to a fertiliser, feeding stuff, compound feeding stuff or mineral mixture shall, if required by an authorised officer, where it is practicable and possible, provide suitable equipment or facilities or a suitable part of the plant or establishment for the officer to carry out his or her functions under this Act.

  13. (13) An authorised officer may require a person to give to the officer such information as is in the person’s power or procurement as regards any premises specified by the officer including—

    • (a) whether or not the premises is used, either partly or wholly, for or in connection with a fertiliser, feeding stuff, compound feeding stuff or mineral mixture,

    • (b) the name of the owner, occupier or person who is in charge of the premises, and

    • (c) whether or not the premises is let and, if let, the name and address of the person to whom, and the period of time for which, it is let.

  14. (14) Nothing in section 17 of the Industrial and Provident Societies Act 1893 prevents an authorised officer from exercising a function conferred on him or her by this Act.

  15. (15) A person who—

    • (a) obstructs or interferes with an authorised officer when exercising a power conferred on him or her under this Act,

    • (b) fails or refuses, without reasonable cause, to comply with a requirement of an authorised officer under this Act,

    • (c) fails, without reasonable cause, to give assistance or requested information to an authorised officer in accordance with this Act,

    • (d) in purporting to give information to an authorised officer for the exercise of the officer’s functions under this Act—

      • (i) makes a statement that he or she knows to be false or misleading in a material particular or recklessly makes a statement which is false or misleading in a material particular, or

      • (ii) intentionally fails to disclose a material particular,

      or

    • (e) aids or abets a contravention of this Act and any instrument made under this Act for the time being in force,

    commits an offence and is liable on summary conviction to a class A fine.

  16. (16) A sample may be taken under this section in the prescribed manner or in any other manner.

  17. (17) Where—

    • (a) a sample is taken under this section in the prescribed manner,

    • (b) the State Chemist or the Assistant State Chemist causes the sample to be analysed in the prescribed manner by any person acting under the direction of the State Chemist or the Assistant State Chemist, and

    • (c) the State Chemist or the Assistant State Chemist gives a certificate in the prescribed form of the result of the analysis,

    evidence of the result of the analysis may be given in any legal proceedings, but save as aforesaid, evidence of the result of an analysis of a sample taken under this section shall not be given in any legal proceedings.

  18. (18) In any legal proceedings the production of a certificate, purporting to be under this section and to be signed by the State Chemist or the Assistant State Chemist, shall be sufficient evidence of the facts stated in the certificate and of the analysis having been duly carried out, unless either party requires the person who made the analysis to be called as a witness.

  19. (19) A statement or admission made by a person pursuant to a requirement under subsection (11)(ii) is not admissible in evidence in proceedings brought against the person for an offence (other than an offence under this section for failing to give information or giving false information) under this Act.

Search warrant

8A. (1) If a judge of the District Court is satisfied by information on oath of an authorised officer that there are reasonable grounds for believing—

- (a) evidence of or relating to the commission or intended commission of an offence under this Act is to be found on a premises,

- (b) there is or was a document or record related to a fertiliser, feeding stuff, compound feeding stuff or mineral mixture, equipment or other thing made, used or adapted for use (including manufacture and transport) in connection with a document or record related to a fertiliser, feeding stuff, compound feeding stuff or mineral mixture, or

- (c) a document or other record related to a thing to which paragraph (a) or (b) refers is or may be on the premises,

  the judge may issue a search warrant.
  • (2) A search warrant under this section shall be expressed and operate to authorise a named authorised officer, accompanied by such authorised officers or other persons as the named authorised officer thinks necessary, at any time, within one month from the date of issue of the warrant, on production if so requested of the warrant, to enter (if necessary by use of reasonable force) the premises, vehicle, vessel or aircraft named in the warrant.

  • (3) If a premises is entered under a warrant issued under this section, an authorised officer so entering may exercise all or any of the powers conferred on an authorised officer under this Act.”.

63. Prosecution of offences - Act of 1955

63. The following section is substituted for section 12 of the Act of 1955:

“12. (1) Proceedings or an offence under this Act may be brought and prosecuted summarily by the Minister.

  • (2) Notwithstanding section 10(4) of the Petty Sessions (Ireland) Act 1851, summary proceedings for an offence under this Act may be instituted within 2 years from the date of the offence.”.

64. Penalties - Act of 1955

64. The Act of 1955 is amended by substituting—

  • (a) in section 2(4), “a class A fine” for “a fine not exceeding twenty-five pounds”,
  • (b) for subsection (3) of section 4 the following:
  • “(3) A person who contravenes a regulation under this section commits an offence and is liable on summary conviction to a class A fine.”,
  • (c) for subsection (6) of section 5 the following:
  • “(6) A person who commits an offence under this section is liable on summary conviction to a class A fine.”,
  • (d) in section 6(3), “a class A fine” for “a fine not exceeding twenty-five pounds”,
  • (e) in section 7(2), “a class A fine” for “a fine not exceeding twenty-five pounds”, and
  • (f) in section 9, “a class A fine” for “a fine not exceeding fifty pounds”.

SCHEDULE

Sections 10, 11, 12(2), 13(1), 18(7), 21(1) and 23(6)

Part 1 Routes of Retail

Options for designation of route of retail in the terms of a marketing authorisation

1.

‘Prescription Only’ — a veterinary medicinal product designated “prescription only” may only be retailed by—

  • (a) a pharmacist from a pharmacy in accordance with a veterinary prescription for the product,
  • (b) a veterinarian where the animal to which the product is to be administered is under his or her care and he or she has issued a veterinary prescription for the veterinary medicinal product, or
  • (c) subject to regulations made under section 12(2), a retail responsible person from a premises to which a retailer’s licence relates, if the person has a veterinary prescription relating to the veterinary medicinal product in his or her possession or it is accessible on the national database.
2.

‘Prescription Only Exempt’ — a veterinary medicinal product designated “prescription only exempt” may only be retailed by—

  • (a) a pharmacist from a pharmacy,
  • (b) a veterinarian where the animal to which the product is to be administered is under his or her care, or
  • (c) subject to regulations made under section 12(2), a retail responsible person from a pharmacy or premises to which a retailer’s licence relates.
3.

‘Licensed Retailer’ — a veterinary medicinal product designated “licensed retailer” may only 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, or
  • (c) by a retail responsible person from a premises to which a retailer’s licence relates.
4.

‘Companion Animal Medicine’ — a veterinary medicinal product designated “companion animal medicine” may only be retailed—

  • (a) from a pharmacy,
  • (b) from a veterinary premises to which a certificate of suitability granted under section 109 of the Act of 2005 applies,
  • (c) from a premises to which a retailer’s licence relates, or
  • (d) from the premises of a person entered in the Register.

Part 2 Symbols denoting Route of Retail

A veterinary medicinal product designated:

  • (a) ‘prescription only’ may be denoted by the following symbol:

POM

  • (b) ‘prescription only exempt’ may be denoted by the following symbol:

POM(E)

  • (c) ‘licensed retailer’ may be denoted by the following symbol:

LR

  • (d) ‘companion animal medicine’ may be denoted by the following symbol:

CAM

Footnotes

1

OJ No. L 4, 7.1.2019, p. 1

2

OJ No. L 4, 7.1.2019, p. 43

3

OJ L 95, 7.4.2017, P. 1-142

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