European Union (Veterinary Medicinal Products and Medicated Feed) Regulations 2022.
Statutory Instruments
Source: Statutory Instruments

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paragraphs: (1) These Regulations may be cited as the European Union (Veterinary Medicinal Products and Medicated Feed) Regulations 2022.
(2) These Regulations come into operation on 28 January 2022.
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paragraphs: (1) In these Regulations —
(a) in Part 2 (Regulations 5 to 8), an Article of the VMP Regulation;
(b) in Part 3 (Regulations 9, 10 and 11), an Article of the Medicated Feed Regulation;
(2) A word or expression that is used in these Regulations and is also used in the VMP Regulation or a Commission delegated or implementing act or the Medicated Feed Regulation has, unless the contrary intention appears, the same meaning in these Regulations as it has in the VMP Regulation or a Commission delegated or implementing act or the Medicated Feed Regulation.
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paragraphs: (1) The competent authority designated in the State to carry out tasks under the VMP Regulation is —
(a) the HPRA, in the case of—
(i) marketing authorisations under Chapter II in accordance with the procedures laid down in Chapter III,
(ii) approval of clinical trials under Article 9,
(iii) in Chapter IV, Article 56, changing terms of marketing authorisations under Section 3, Articles 70, 71 and 72 and Sections 5 and 6,
(iv) registration of homeopathic veterinary medicinal products under Chapter V,
(v) manufacturing authorisation under Chapter VI and in that Chapter (including making a decision under Article 88(2)), Article 91(3) in respect of recording manufacturing on the database, Articles 94, and 97(5) and 98,
(vi) registration of active substance manufacturers, importers and distributors in Article 95, and in respect of recording related information on the database pursuant to Article 91(3),
(vii) in Chapter VII, Articles 102, 123, 125, 126, 127, 128 and 129, 130 and
(viii) in Chapter IX, Articles 133, 134, 151, 152, 155, 157 and 159,
and
(b) the Minister, in the case of—
(i) collecting data under Article 57,
(ii) Article 91(3) in respect of recording wholesale distribution on the database,
(iii) granting wholesale distribution authorisation under Section 1 of Chapter VII and its suspension or revocation under Article 131, and
(iv) derogations under Articles 104(2), 110, 116 and 120(2).
(2) The HPRA may decide if a manufacturing authorisation is not required for the purposes of Article 88(2) of the VMP Regulation.
(3) The Minister is the competent authority in the State for the Medicated Feed Regulation.
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paragraphs: (1) The following are revoked:
(a) the European Communities (Animal Remedies) (No. 2) Regulations 2007 (S. I. No. 786 of 2007);
(b) the European Communities (Animal Remedies) (Amendment) Regulations 2009 (S. I. No. 182 of 2009);
(c) the European Communities (Animal Remedies) (Amendment) Regulations 2012 (S. I. No. 262 of 2012);
(d) the European Communities (Animal Remedies) (Amendment) Regulations 2014 (S. I. No. 162 of 2014);
(e) the European Communities (Animal Remedies) (Amendment) (No. 2) Regulations 2014 (S. I. No. 361 of 2014);
(f) the European Communities (Animal Remedies) (Amendment) Regulations 2016 (S. I. No. 278 of 2016).
(2) The European Communities (Animal Remedies and Medicated feedingstuffs) Regulations 1994 (S. I. No. 176 of 1994) are revoked.
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paragraphs: (1) A person who places on the market a veterinary medicinal product without holding a marketing authorisation granted by the competent authority or the European Commission for the product in contravention of Article 5(1) commits an offence.
(2) A person who conducts a clinical trial without approval under Article 9 commits an offence.
(3) A person who fails to comply with Section 4 of Chapter II of the VMP Regulation in respect of labelling and package leaflets commits an offence.
(4) The holder of a marketing authorisation or a registration of homeopathic veterinary medicinal products who fails to comply with Article 58, 76, 77 or 81 commits an offence.
(5) A qualified person responsible for pharmacovigilance who fails to comply with Article 78(1) commits an offence.
(6) A person who makes available a homeopathic veterinary medicinal product which is not registered in accordance with Chapter V of the VMP Regulation commits an offence.
(7) A person who engages in any of the activities referred to in Article 88(1) without holding a manufacturing authorisation commits an offence.
(8) The holder of a manufacturing authorisation who fails to comply with Article 93 commits an offence.
(9) An importer, manufacturer or a distributor of an active substance used as starting materials in veterinary medicinal products who fails to register their activity in accordance with Article 95 commits an offence.
(10) The holder of a manufacturing authorisation who fails to keep records in accordance with Article 96 commits an offence.
(11) The holder of a manufacturing authorisation or a qualified person who fails to comply with Article 97 commits an offence.
(12) A person who is not the holder of a wholesale distribution authorisation who carries out wholesale distribution of veterinary medicinal products commits an offence.
(13) A wholesale distributor who fails to comply—
(a) with the obligations of wholesale distributors under Article 101, or
(b) for the purpose of parallel trade in veterinary medicinal products, with Article 102,
(14) A retailer of veterinary medicinal products who fails to comply with Article 103 commits an offence.
(15) A retailer of veterinary medicinal products retailing veterinary medicinal products at a distance who fails to comply with Article 104(1) or (5) commits an offence.
(16) A person who issues a veterinary prescription that fails to comply with the requirements set out in Article 105 commits an offence.
(17) A person who fails to comply with Article 106(1) by using a veterinary medicinal product other than in accordance with the terms of its marketing authorisation commits an offence.
(18) A person who fails to comply with Article 107 in the use of antimicrobial medicinal products commits an offence.
(19) The owner or keeper of a food-producing animal who fails to keep records in accordance with Article 108 commits an offence.
(20) A veterinarian referred to in Article 111(1) who fails to comply with that paragraph commits an offence.
(21) A veterinarian who fails to comply with Article 112, 113 or 114 when using medicinal products outside the terms of the marketing authorisations commits an offence.
(22) A veterinarian who fails to comply with Article 115 in respect of the withdrawal period for medicinal products used outside the terms of the marketing authorisation in food-producing animals commits an offence.
(23) A person who advertises veterinary medicinal products other than in accordance with Article 119 or 120 commits an offence.
(24) A person who promotes medicinal products used in animals in contravention of Article 121 commits an offence.
(25) The holder of a marketing authorisation who fails to comply with Article 127(1) or 128 in respect of the results of the control test carried out on a veterinary medicinal product commits an offence.
(26) A person who fails to comply with temporary safety restrictions imposed under Article 129 commits an offence.
(27) A person who supplies, fails to cease to supply or fails to recall a veterinary medicinal product the supply of which is prohibited or recalled under Article 134 commits an offence.
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paragraphs: A person who commits an offence under —
(a) paragraph (3), (4), (5), (6), (8), (9), (10), (11), (13), (23), (24) or (25) of Regulation 5, is liable on summary conviction to a class A fine, or
(b) paragraph (1), (2), (7), (12), (14), (15), (16), (17), (18), (19), (20), (21), (22), (26) or (27) of Regulation 5, is liable —
(i) on summary conviction, to a class A fine, or
(ii) on conviction on indictment, to a fine not exceeding €300,000.
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paragraphs: (1) The HPRA may allow an identification code to be added on the immediate or outer packaging of a veterinary medicinal product in addition to the information referred to in Article 10(1) and 11(1).
(2) The HPRA may, on request by an applicant, allow on the immediate or outer packaging of a veterinary medicinal product additional useful information referred to in Article 13.
(3) A packaging leaflet shall be made available on paper and in addition, optionally electronically.
(4) A person who fails to comply with paragraph (3) commits an offence and is liable on summary conviction to a class A fine.
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paragraphs: (1) A marketing, manufacturing or distribution authorisation or approval for clinical trial or parallel trade shall contain such terms as the competent authority decides. The authorisation or approval may be suspended or revoked if any of the terms attached to it are not complied with.
(2) The competent authority shall grant, refuse, suspend, revoke or amend by way of variation a marketing, manufacturing or distribution authorisation or clinical trial or parallel trade approval or registration of homeopathic veterinary medicinal products under the VMP Regulation.
(3) Applications to the competent authority for authorisation or approval or registration or amendments to such applications under the VMP Regulation shall be made in writing, or electronically to the competent authority in such form and manner as it decides accompanied by the fee to cover the costs of administration and such information as the competent authority decides.
(4) Decisions to grant, refuse, suspend, revoke or amend by way of variation a marketing authorisation, or a registration of a homeopathic veterinary medicinal product by the competent authority shall be published by the competent authority and in such form as it decides.
(5) Except in the circumstances set out in Section 6 of Chapter III or Section 6 of Chapter IV of the VMP Regulation, where the European Commission takes a decision, the competent authority shall inform the applicant of any proposed refusal, or the holder of an authorisation approval or registration of any proposed suspension, revocation or amendment by way of variation, of an authorisation, approval or registration under the VMP Regulation made by the competent authority. In relation to the competent authority’s proposal, the applicant or holder may within such period as the competent authority allows, being not less than 14 days, make representations in writing to the competent authority in relation to the proposal, who shall consider and inform the applicant or holder of its decision.
(6) If an applicant or holder is aggrieved by a decision of the competent authority under paragraph (5) in respect of representations made and considered, they may request the Minister or the HPRA’s Advisory Committee for Veterinary Medicines, as the case may be, not later than 21 days after notification of the decision, to establish a panel to adjudicate on the matter. The Minister or the HPRA’s Advisory Committee for Veterinary Medicines, unless they consider the request vexatious, shall establish a panel with one or more persons, who he or she considers are suitably qualified and independent to adjudicate on the matter. The panel shall set its own procedure and adjudicate on the matter. The decision of the panel is final, other than on a point of law, which lies with the High Court.
(7) Authorisations, approvals or registrations granted under the European Communities (Animal Remedies) (No. 2) Regulations 2007 (S. I. No. 786 of 2007) (“2007 Regulations”) which are in force immediately before the commencement of these Regulations continue in force and are deemed to have been issued in accordance with the corresponding provision of the VMP Regulation and are, as such, subject to the relevant provisions of the VMP Regulation.
(8) Fees for applications for authorisations, approvals or registrations and inspections are not refundable.
(9) (a) A person who- —
(i) possesses or uses, or
(ii) distributes, sells or supplies or imports, or possesses with the intention of distributing, selling or supplying,
a veterinary medicinal product which has not been granted a marketing authorisation by the competent authority or the European Commission, or the competent authority of another Member State, unless its use is permitted in the State, commits an offence.
(b) This paragraph does not apply to a veterinary medicinal product—
(i) allowed under Article 110, 111 or 116 or used under 112, 113 or 114, or
(ii) authorised under the European Union (Protection of animals used for Scientific Purposes) Regulations 2012 (S. I. No. 543 of 2012).
(10) A person who commits an offence under—
(a) paragraph (9)(a)(i), is liable on summary conviction to a class a fine, or
(b) paragraph (9)(a)(ii), is liable—
(i) on summary conviction, to a class A fine, or
(ii) on conviction on indictment, to a fine not exceeding €300,000.
(11) Where by way of derogation under Article 106(1) of the VMP Regulation—
(a) the competent authority allows the use of an immunological veterinary medicinal product in accordance with Article 110(2, 3 or 5) or a veterinary medicinal product in accordance with Article 116, a person who fails to use the product in accordance with the allowance, or
(b) a veterinarian who treats an animal in the circumstances referred to in Article 112, 113 or 114 with a product referred to in paragraph (1) of Article 112, 113 or 114, as the case may be, but fails to follow the steps for such treatment as set out in that Article,
(i) on summary conviction, to a class A fine, or
(ii) on conviction on indictment, to a fine not exceeding €50,000.
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paragraphs: (1) A feed business operator who fails to comply with Article 4 in respect of the manufacture, storage, transport or placing on the market of medicated feed or intermediate products commits an offence.
(2) A feed business operator manufacturing medicated feed or intermediate product who fails to comply with Article 5, 6, 7 or 8 commits an offence.
(3) A person who fails to comply with the specific labelling requirements of Article 9 commits an offence.
(4) A person who fails to comply with the packaging requirements of Article 10 commits an offence.
(5) A person who contravenes the prohibition of advertising medicated feed and intermediate products under Article 11(1) commits an offence.
(6) A person who fails to comply with the advertising, distribution or labelling requirements of Article 11 (2), (3), (4) or (5) commits an offence.
(7) A feed business operator distributing medicated feed or intermediate products who fails to comply with Article 12 commits an offence.
(8) A feed business operator manufacturing, storing, transporting or placing on the market medicated feed or intermediate products who fails to comply with the approval obligation under Article 13(1) commits an offence.
(9) A mobile mixer who fails to comply with Article 13(4) commits an offence.
(10) A person who fails to comply with the prescription requirements of Article 16 commits an offence.
(11) An animal keeper or other person who fails to use medicated feed in accordance with Article 17 commits an offence.
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paragraphs: A person who commits an offence under —
(a) paragraph (2), (3), (4), (6), (7), (9) or (11) of Regulation 9, is liable on summary conviction to a class A fine, or
(b) paragraph (1), (5), (8) or (10) of Regulation 9, is liable —
(i) on summary conviction, to a class A fine, or
(ii) on conviction on indictment, to a fine not exceeding €300,000.
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paragraphs: (1) Upon application to it in writing and in such form as it decides, the competent authority may approve in accordance with Article 13 establishments under the control of a feed business operator manufacturing, storing, transporting or placing on the market medicated feed or intermediate products.