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Chapter 6
Matters under national law mentioned in VMP Regulation or Medicated Feed Regulation
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Regulations - additional to VMP Regulation and Medicated Feed Regulation
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32. (1) The Minister may make regulations in relation to matters mentioned in the VMP Regulation that are to be determined by national law or to be put in place by national procedures or that the State is permitted to do, including—
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(a) requiring the availability of a packaging leaflet in such a format as permitted under Article 14(3),
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(b) imposing specific requirements on veterinarians or other health professionals in respect of the reporting of suspected adverse events as permitted under Article 79(2),
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(c) imposing conditions on the role of responsible person as permitted under Article 100(2)(a),
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(d) the supply by a wholesale distributor of veterinary medicinal products for the purposes of Article 101(2),
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(e) as permitted under Article 104(2) allowing for the retail at a distance within the State of veterinary medicinal products subject to a prescription,
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(f) as permitted under Article 105(11), making rules on record-keeping for veterinarians when issuing veterinary prescriptions,
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(g) as permitted under Article 105(12), requiring a veterinarian to issue a veterinary prescription for administered medicines and recording of such,
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(h) as permitted under Article 107(7), making further restrictions or prohibitions on the use of antimicrobials in animals,
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(i) as permitted under Article 108(4), making additional requirements for record-keeping by owners and keepers of food-producing animals,
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(j) as permitted under and in accordance with Article 110(1), prohibiting the manufacture, import, distribution, possession, sale, supply or use of immunological veterinary medicinal products, or
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(k) for the purpose of Article 117, providing that appropriate systems are in place for the collection and disposal of waste veterinary medicinal products,
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of the VMP Regulation.
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(2) The Minister may make regulations—
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(a) establishing maximum levels of cross contamination for active substances in non‑target feed as permitted under Article 7(5),
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(b) laying down procedures for the approval of establishments under Article 13, including a licencing system,
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(c) for the purpose of Article 13(5), to ensure that relevant information regarding the activities of retailers of medicated feed for pets is available to the Minister including requiring a registration or licencing system, or
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(d) for the purpose of Article 18, providing that appropriate collection and discard systems are in place for medicated feed and intermediate products that are expired or in case an animal keeper has received a larger quantity of medicated feed than is actually used for the treatment referred to in the veterinary prescription for medicated feed,
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of the Medicated Feed Regulation.
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(3) A person who contravenes or fails to comply with a provision of a regulation made under—
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(a) this section (other than under subsection (1)(h), (j) or (k) or subsection (2)(d)) commits an offence and is liable on summary conviction to a class A fine, or
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(b) subsection (1)(h), (j) or (k) or subsection (2)(d) commits an offence and is liable—
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(i) on summary conviction, to a class A fine, or
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(ii) on conviction on indictment, to a fine not exceeding €100,000.
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