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Licencing of import of medicinal products in relation to their use under Articles 110 to 114 or 116 of VMP Regulation
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25. (1) The Minister may, on application, authorise in accordance with Article 106(3) of the VMP Regulation by licence, to be known as a special import licence, or notification to be known as a special import notification, the import, possession, retail or use of a veterinary medicinal product for the purposes of Article 110 or 116, or a medicinal product for the purposes of Article 111, 112, 113 or 114, of the VMP Regulation by—
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(a) a veterinarian,
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(b) the holder of a wholesale distribution authorisation, or
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(c) the holder of a marketing authorisation.
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(2) A person who imports, possesses, retails or uses a medicinal product—
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(a) for the purposes of Article 110 or 116 of the VMP Regulation, or
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(b) for the purposes of Article 112, 113 or 114 of the VMP Regulation, that has not been granted a marketing authorisation by the competent authority or the European Commission,
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without holding a special import licence or notification 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 €300,000.
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(3) The Minister may make regulations as permitted by Article 106(3) of the VMP Regulation on procedures required for the implementation of Articles 110 to 114 and 116.
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