Veterinary Medicinal Products, Medicated Feed and Fertilisers Regulation Act 2023
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Obligations of holder of retailer’s licence | ||
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19. (1) The holder of a retailer’s licence shall obtain a veterinary medicinal product only from a holder of a wholesale distribution authorisation authorised to distribute veterinary medicinal products or a holder of a manufacturing authorisation authorised to manufacture the product. | ||
(2) A person who fails to comply with subsection (1) commits an offence and is liable on summary conviction to a class A fine. | ||
(3) The holder of a retailer’s licence when retailing a veterinary medicinal product shall— | ||
(a) ensure that a retail responsible person provides advice to the end user on the appropriate storage, administration, contraindications, withdrawal period, disposal of the veterinary medicinal product and procedures for reporting suspected adverse events, | ||
(b) ensure that a retail responsible person obtains the consent of the end user before dispensing to him or her a product in accordance with regulations made for the purposes of section 6 (1)(d) and shall ensure the end user is fully advised of any product differences to the prescribed product including withdrawal periods, | ||
(c) not retail the product except to an end user of the product or a veterinarian in small quantities, in accordance with Article 99 of the VMP Regulation, | ||
(d) comply with any advertising requirements of Section 4 of Chapter VII of the VMP Regulation or guidance provided by the Minister in relation to veterinary medicinal products, | ||
(e) provide and maintain premises, equipment and staff and have in operation arrangements necessary to avoid deterioration of the product and to notify the Minister within 7 days of a material change in the premises, equipment, staff or arrangements of the holder, | ||
(f) permit inspections by authorised officers and make available information required to satisfy the Minister that the conditions of the licence are being complied with, | ||
(g) immediately withdraw, if directed by the Minister, the European Medicines Agency, the Health Products Regulatory Authority, the marketing authorisation holder or the wholesale distribution authorisation holder, from retail any quantity, and, in so far as is practicable, immediately recall any quantity sold or supplied of— | ||
(i) a batch or part of a batch of a product that does not conform with a marketing authorisation or the strength, quality or purity does not conform with the specification of that veterinary medicinal product, or | ||
(ii) a product that has given rise to unacceptable adverse events, unacceptable environmental safety or consumer safety concerns or a negative benefit or risk balance as decided by the person so directing, | ||
(h) report any suspected adverse events as defined in Article 73(2) of the VMP Regulation, that they are made aware of, to the marketing authorisation holder of the veterinary medicinal product or the competent authority concerned designated under Article 137 of the VMP Regulation, | ||
(i) have in place the necessary systems to receive from those that they retail to, the veterinary medicinal product that is unused or expired for the return to the person from whom they purchased that product and in addition take steps to ensure that customers are aware of the arrangements, | ||
(j) ensure the premises of the holder and the retail and storage of veterinary medicinal products conform with the conditions in the holder’s licence, | ||
(k) in addition to keeping records of veterinary medicinal products requiring a veterinary prescription, keep records of such products not subject to veterinary prescription, and | ||
(l) comply with such further obligations specified in regulations by the Minister having regard in particular to the need to adequately safeguard public and animal health. | ||
(4) Where the Minister considers that the holder of a retailer’s licence is not complying with the obligations of a holder under subsection (3), the Minister shall notify the holder of this and require the holder to comply with the obligation in accordance with the notification within such time as specified in the notification. If the holder of the licence does not comply with the notification or does not comply with it to the satisfaction of the Minister, the Minister may withdraw the licence indefinitely or until the holder complies with the notification and section 34 (6) applies to any proposed withdrawal. |