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S.I. No. 36/2022 - European Union (Veterinary Medicinal Products and Medicated Feed) Regulations 2022

Type Statutory Instrument

Publication 2022-01-28

State In force

Text As published

Source Irish Statute Book

articles 15

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.

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(c) a compliance notice has been confirmed with or without modification under Regulation 35(5) and the notice has not been complied with,

then the authorised officer may seize and detain the product or feed and any means of transport or other thing used in connection with such.

(2) Where a veterinary medicinal product or any ingredient for a veterinary medicinal product or medicated feed or intermediate product, means of transport or other thing is seized and detained under paragraph (1), an authorised officer may—

(a) sell, destroy or dispose of the product, feed or other thing or cause it to be sold, destroyed or disposed of, or

(b) take such other measures in relation to the product, feed, means of transport or other thing as the authorised officer considers appropriate, in the circumstances.

(3) The profits, if any, arising out of the sale, destruction or disposal of a veterinary medicinal product or any ingredient for a veterinary medicinal product or medicated feed or intermediate product, means of transport or other thing seized and detained under paragraph subsection (1) shall be paid to the owner of the product, feed, means of transport or other thing less any expenses (including ancillary expenses) incurred in connection with the seizure, detention, sale, destruction or disposal.

(4) The costs (including ancillary costs) of a measure taken under this section may be recovered by the Minister—

(a) as a simple contract debt in a court of competent jurisdiction from the person who was the owner of the veterinary medicinal product or any ingredient for a veterinary medicinal product or medicated feed or intermediate or means of transport or other thing at the time the measure was carried out, or

(b) by deducting the costs from any moneys due, or becoming due, and payable by the Minister to the person on whom the compliance notice concerned was served.

(5) Where the Minister proposes to recover the costs of anything done under this Regulation the Minister shall—

(a) inform by notice the person concerned of the costs (including, but not limited to, salaries, subsistence, hiring of vehicles, machinery or equipment, feeding and veterinary fees) the reason for the costs and that he or she may make representations in relation to the proposal not later than 14 days from the date of the notice,

(b) consider any representations duly made, and

Impersonation of an authorised officer, etc. and possession of certain identity documents

37.

(1) A person who, with the intention to deceive—

(a) purports to be, or

(b) acts in a manner that would lead another person to believe that he or she is,

a person duly appointed as an authorised officer or other officer of the Minister either generally or for the purposes of these Regulations commits an offence and is liable on summary conviction to a class A fine or to imprisonment for a term not exceeding 6 months, or both.

(2) A person who, without lawful excuse, has in his or her possession any document which—

(a) has been,

(b) purports to be, or

duly issued for the purpose of identifying the person in possession of the document as a person duly authorised by, or a duly authorised officer or other officer of the Minister either generally or for the purposes of these Regulations commits an offence and is liable on summary conviction to a class A fine or to imprisonment for a term not exceeding 6 months, or both.

Evidence of class of veterinary medicinal product to which a contravention relates

38.

In any proceedings for an offence under these Regulations in which it is alleged that a contravention of these Regulations has occurred in relation to a class of veterinary medicinal product or a class of ingredient for a veterinary medicinal product or a class of medicated feed or intermediate products, it shall not be necessary to show that the contravention relates to a particular veterinary medicinal product or ingredient for a veterinary medicinal product or a particular medicated feed or intermediate product where it can be shown that it relates to a thing which is a member of such a class of veterinary medicinal product or class of ingredient for a veterinary medicinal product or medicated feed or intermediate product.

Disposal of things seized

39.

If, in the course of exercising a power under this Part, a person, being an authorised officer, a member of the Garda Síochána or an officer of customs, finds or comes into possession of any thing which such a person believes to be evidence of any offence or suspected offence under these Regulations, it may be seized and retained for use in evidence in any criminal proceedings, for such period from the date of seizure as is reasonable or, if proceedings are commenced in which the thing so seized is required for use in evidence, until the conclusion of the proceedings, and thereafter it shall be returned to its owner, unless—

(a) returning it would cause the owner to be in possession of the seized item contrary to law,

(b) the expiry date of a seized medicine has expired,

(d) an order from the court has been obtained to otherwise dispose of it,

and an authorised officer may, other than where paragraph (c) or (d) applies, approve the disposal, without payment or compensation of the thing following the issuing of a disposal notice to the owner giving him or her 10 days to appeal the decision to the Minister to dispose.

Evidence on certificate, etc.

40.

(1) In proceedings for an offence under these Regulations consisting of a contravention of an applicable (EU) Regulation, a certificate purporting to be signed by a person employed at a laboratory named in the certificate stating the capacity in which that person is so employed and stating one or more of the following, namely—

(a) that the person received a sample submitted to the laboratory,

(b) that, for a period as is specified in the certificate, the person had in his or her custody a sample so submitted,

(d) that the person carried out a laboratory examination for the purpose of detecting the presence, in a sample so submitted, of a substance, ingredient for a veterinary medicinal product or medicated feed or intermediate product or a veterinary medicinal product or medicated feed or intermediate product, or

(e) that a particular substance, ingredient for a veterinary medicinal product or medicated feed or intermediate product or a veterinary medicinal product or medicated feed or intermediate product was present in the sample,

is, unless the contrary is shown, evidence of the matters stated in the certificate.

(2) A certificate purporting to be signed by an officer of the Minister and to certify that on a specific day or days or during the whole of a specified period-

(a) a particular person or organisation did not hold a marketing, manufacturing or distribution authorisation, clinical trial or parallel trade approval or registration of homeopathic veterinary medicinal products,

(b) a marketing, manufacturing or distribution authorisation, clinical trial or parallel trade approval or registration of homeopathic veterinary medicinal products is suspended or has been revoked,

(c) a person or organisation was or was not the holder of a marketing, manufacturing or distribution authorisation, clinical trial or parallel trade approval or was not authorised, or

(d) that a particular authorisation, approval or registration, referred to in this paragraph, was subject to a particular condition or conditions,

is, without proof of the signature of the person purporting to sign the certificate or that he or she is an officer of the Minister, evidence, unless the contrary is shown, of the matters stated in the certificate.

(3) In proceedings for an offence under these Regulations the court may, if it considers that the interests of justice so require, direct that oral evidence of any matter stated in a certificate under paragraph (1) or (2) be given, and the court may for the purpose of receiving oral evidence adjourn the matter.

Offences by bodies corporate, etc.

41.

(1) Where an offence under these Regulations has been committed by a body corporate and it is proved to have been so committed with the consent or connivance of or to be attributable to any willful neglect on the part of any person who, when the offence was committed, was a director, manager, secretary or other officer of the body corporate, or a person purporting to act in any such capacity, that person, as well as the body corporate, shall be guilty of an offence and shall be liable to be proceeded against and punished as if guilty of the first-mentioned offence.

(2) Where the affairs of a body corporate are managed by its members, paragraph (1) shall apply in relation to the acts and defaults of a member in connection with the functions of management as if such a member were a director or manager of the body corporate.

Fixed payment notice

42.

(1) Where an authorised officer has reasonable grounds for believing that a person is committing or has committed an offence referred to in paragraph (a) of Regulation 6 or paragraph (a) of Regulation 10 or under Regulation 7(4), 20 (11) or 22(2) or Part 4, he or she shall report this to another officer of the competent authority concerned authorised in that behalf.

(2) An officer who receives a report under paragraph (1), if he or she considers it appropriate, may serve on the person a notice in writing (“fixed payment notice”) stating that—

(a) the person is alleged to have committed the offence,

(b) the person may during the period of 28 days beginning on the date of the notice make to the Minister, at the address specified in the notice, a payment of €250 accompanied by the notice (if required in the notice),

(d) a prosecution in respect of the alleged offence will not be instituted during the period specified in the notice and, if the payment specified in the notice is made during that period, no prosecution in respect of the alleged offence will be instituted.

(3) Where a fixed payment notice is served under paragraph (2)—

(a) the person to whom the notice applies may, during the period specified in the notice, make to the Minister at the address specified in the notice the payment specified in the notice accompanied by the notice (if required in the notice),

(b) the Minister may receive the payment, issue a receipt for it and retain the money so paid, and any payment so received shall not be recoverable in any circumstances by the person who made it, and

(c) a prosecution in respect of the alleged offence shall not be instituted in the period specified in the notice, and if the payment so specified is made during that period, no prosecution in respect of the alleged offence shall be instituted.

(4) In proceedings for an offence referred to in paragraph (1) the onus of proving that a payment in accordance with a fixed payment notice has been made lies on the person on whom the fixed payment notice was served.

(5) In proceedings for an offence referred to in paragraph (1) it is a defence for the accused to show that he or she has made a payment in accordance with this section pursuant to a fixed payment notice issued in respect of that offence.

Service of notices and notifications

43.

(1) Subject to paragraph (2), any notice, notification or document required or authorised by virtue of an applicable (EU) Regulation to be given to any person by the competent authority or required to be given under these Regulations shall be addressed to the person concerned by name and may be given –

(a) by delivering it to the person,

(b) by leaving it at the address at which the person carries on business or ordinarily resides or, in the case in which an address for service has been furnished, at that address,

(c) by sending it by post in a prepaid registered letter to the address at which the person carries on business or ordinarily resides or, in a case in which an address for service has been furnished, to that address, or

(d) by electronic communication, if the person concerned has agreed to service of notices, notifications or documents by such means, provided that there is a facility for confirming receipt of the electronic communication and that such receipt has been confirmed.

(2) For the purposes of this Regulation, a company within the meaning of the Companies Act 2014 (No. 38 of 2014) shall be deemed to be ordinarily resident at its registered office, and every other body corporate and every unincorporated body shall be deemed to be ordinarily resident at its principal office or place of business.

Summary proceedings

44.

Proceedings for an offence may be brought and prosecuted summarily by—

(a) in any case, the Minister, or

(b) in a case where the HPRA is the competent authority, the HPRA.

Disqualification from keeping animals, veterinary medicinal products, or medicated feed, etc.

45.

(1) A person who is convicted on indictment of an offence under these Regulations may, in addition to the penalty imposed thereunder—

(a) be disqualified from keeping, dealing in or having charge or control, directly or indirectly, of either or both—

(i) any animal or class or classes of animal, and

(ii) any veterinary medicinal product or medicated feed or class or classes of a veterinary medicinal product or medicated feed or any ingredient thereof,

(b) be disqualified from working in or having charge or control of any one or more of the following, that is to say, the manufacture, importation, preparation, handling, storage, transport, exportation, distribution, sale or supply of either or both food intended for human consumption and food intended for animal consumption or of any class or classes of either or both such foods,

for such period, including where appropriate for the life of the person, as the court thinks fit.

(2) In this Regulation “control” includes, in relation to a body corporate, the power of the person concerned to secure, by means of holding shares or the possession of voting power in or in relation to that or any other body corporate, or by virtue of powers conferred by articles of association or other document regulating that or any other body corporate, that the affairs of the first-mentioned body corporate are conducted in accordance with the wishes of that person.

Forfeiture of animal, veterinary medicinal product, etc.

46.

(1) Where—

(a) a veterinary medicinal product,

(b) an ingredient for a veterinary medicinal product,

(d) any thing used in connection with an unauthorised veterinary medicinal product or any thing directly used in connection with any other veterinary medicinal product, or

(e) any thing used in connection with an animal to which a prohibited a veterinary medicinal product has been administered or any thing directly used in connection with an animal to which any other veterinary medicinal product has been administered,

has come into the possession of an authorised officer in respect of which an offence is with reasonable cause suspected by the officer of having been committed under these Regulations, or where an offence has been committed or is alleged to have been committed under these Regulations in respect of any of the matters referred to in paragraph (a), (b), (c), (d) or (e), and on the application before a court of—

(i) the Minister, or

(ii) where criminal proceedings have been instituted, the person who instituted those proceedings,

the appropriate court may, at its discretion and where it is satisfied that an offence has been committed (whether or not any person has been convicted of the offence) order the forfeiture of any such animal, veterinary medicinal product, ingredient for a veterinary medicinal product, or other thing, as the case may be.

(2) Any thing ordered by the appropriate court to be forfeited under this Regulation shall be disposed of as the Minister thinks fit, and any moneys arising from such disposal shall, without prejudice to it being taken into account (where appropriate) for the purposes of Regulation 47, be paid into or disposed of for the benefit of the Exchequer in such manner as the Minister for Finance shall direct.

(3)
(a) In this section—

“appropriate court” means—

(i) in case the estimated value of the animal, veterinary medicinal product, ingredient for a veterinary medicinal product or other thing to be forfeited does not exceed €15,000, the District Court,

(ii) in case the estimated value aforesaid does not exceed €75,000, the Circuit Court,

(iii) in any case, the High Court;

“estimated value”, in relation to the thing sought to be forfeited, means the estimated amount of money which, in the opinion of the court, a willing purchaser would pay to a willing seller when such a thing could be sold legally and after deduction for—

(I) the estimated costs incidental to such a sale, and

(II) the estimated amount of any tax or duty owing to the State in respect of that thing,

and when it cannot be sold legally then such estimated value, if any, as the court considers appropriate.

(b) (i) If, in relation to an application under this section to the District Court, that court becomes of the opinion during the hearing of the application that—

(I) the estimated value aforesaid will exceed €15,000, or

(II) that for any reason it should decline jurisdiction,

it may, if it so thinks fit, transfer the application to the Circuit Court or the High Court, whichever it considers appropriate having regard to the estimated value aforesaid or to such other matters that it considers appropriate.

(ii) If, in relation to an application under this section to the Circuit Court, that court becomes of opinion during the hearing of the application that—

(I) the estimated value aforesaid will exceed €75,000, or

(II) that for any reason it should decline jurisdiction,

it may, if it so thinks fit, by order transfer the application to the High Court.

(4)
(a) An order shall not be made by a court under this section unless the court is satisfied that in the circumstances all practicable steps have been taken to notify any person of the proceedings relating to the application for the order and who, in the opinion of the court, should be given the opportunity of being heard by it on that application.

(b) The court concerned may make such order as to the costs of the parties to or heard by the court in proceedings relating to an application for an order under this section as it considers appropriate.

Recoupment of costs of certain disposals

47.

Where any thing which is seized from or forfeited by a person under these Regulations is duly disposed of by or on behalf of the State, the costs of such disposal, less any moneys arising from such disposal, shall (except where such costs have been waived in writing) be recoverable from such person as a simple contract debt in any court of competent jurisdiction.

Forgery

48.

(1) A person shall not forge a document purporting to be—

(a) a veterinary prescription,

(b) an authorisation or approval or registration under the VMP Regulation, or

(c) a record required to be kept under, or any other document issued or maintained under, an applicable EU Regulation or these Regulations,

(which is, in this Regulation, referred to as a “forged document”).

(2) A person shall not forge an endorsement or other entry purporting to be for any purpose of an applicable EU Regulation on any document whatsoever required to be kept for the purposes of an applicable EU Regulation (which document with such entry in this Regulation is referred to as a “falsely endorsed document”).

(3) A person shall not, with intent to deceive, alter—

(a) a veterinary prescription,

(b) an authorisation or approval or registration under the VMP Regulation, or

(which document if so altered is, in this Regulation, referred to as an “altered document”).

(4) A person shall not utter a forged document, a falsely endorsed document or an altered document.

(5) A person shall not have in his or her possession or under his or her control, a forged document, a falsely endorsed document or an altered document.

(6) Paragraph (5) does not apply to—

(a) an authorised officer or a member of the Garda Síochána or an officer of customs, when acting in the course of his or her duty, or

(b) a person who has taken into his or her possession a document for the purpose of—

(i) preventing another from committing or continuing to commit an offence, or

(ii) delivering it into the custody of a person specified in subparagraph (a).

(7) A person who contravenes this Regulation 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,

(b) on conviction on indictment, to a fine not exceeding €50,000, or to imprisonment for a term not exceeding 2 years, or to both.

GIVEN under my Official Seal,

27 January, 2022.

CHARLIE MCCONALOGUE,

Minister for Agriculture, Food and the Marine.

EXPLANATORY NOTE

(This note is not part of the instrument and does not purport to be a legal interpretation)

These Regulations give effect to Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018, and the European Commission implementing and delegated acts referred to in the following regulations adopted thereunder on veterinary medicinal products, and Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed by providing for offences and penalties for contravention of such and enforcement measures.

Footnotes

OJ No. L 4, 7.1.2019, p.43

OJ No. L 4, 7.01.2019, p.1

OJ No. L 123, 9.4.2021, p. 3

OJ No. L 123, 9.4. 2021, p. 7

OJ No. L 7, 11.1. 2021, p. 1

OJ No. L 272, 30.7.2021, p. 46

OJ No. L 279, 3.8.2021, p. 1

OJ No. L 279, 3.8.2021, p. 15

OJ No. L 387, 3.11.2021, p. 133

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