Veterinary Medicinal Products, Medicated Feed and Fertilisers Regulation Act 2023
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National database | ||
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7. (1) The Minister shall establish and maintain a database (“national database”) on which veterinary prescriptions and dispensing of veterinary prescriptions shall be recorded. | ||
(2) Subject to regulations made under section 6 (1) for the purposes of paragraph (c), a veterinary prescription shall be issued electronically and dispensed and recorded on or transmitted to the national database. | ||
(3) Subject to subsection (4), a person who issues a veterinary prescription or dispenses a medicinal product or medicated feed on foot of a veterinary prescription shall record on, or cause to be transmitted to the national database the issuing of the prescription or dispensing of the product. The format of the recording and transmission to the national database shall be in accordance with any regulations made under subsection (6). | ||
(4) The Minister shall cause to be electronically stored on the national database information obtained under subsection (2) for the purposes set out in subsection (6). | ||
(5) Information held on the national database— | ||
(a) may be shared with the following persons: | ||
(i) the Food Safety Authority of Ireland for the purpose of performing its regulatory functions; | ||
(ii) the Health Products Regulatory Authority in their role as a competent authority for the VMP Regulation; | ||
(iii) the Veterinary Council of Ireland for the purpose of performing their functions under the Act of 2005; | ||
(iv) the Pharmaceutical Society of Ireland for the purposes of performing their functions under the Act of 2007; | ||
(v) Bord Bia for the purpose of quality assurance inspections and processes; | ||
(vi) the European Commission for the purpose of audit and control; | ||
(vii) the European Court of Auditors for the purpose of audit and control; | ||
(viii) such other persons specified by the Minister in regulations where sharing such information is necessary— | ||
(I) to comply with this Part or end user obligations under the VMP Regulation or the Medicated Feed Regulation, or | ||
(II) having regard to the need to adequately safeguard public or animal health or the environment, | ||
and | ||
(b) may be accessed and used by the Minister and, subject to being required to be registered on it in accordance with regulations made under subsection (6) for the purpose of paragraph (e), the following persons: | ||
(i) veterinarians and persons engaged on their behalf for the purposes of using the national database to the extent necessary for the issuing and dispensing of veterinary prescriptions for their own clients; | ||
(ii) dispensers and persons engaged on their behalf to the extent necessary for the purposes of using the national database when dispensing a veterinary prescription; | ||
(iii) keepers and owners of animals subject to a veterinary prescription to the extent necessary for animals under their care; | ||
(iv) such other persons specified by the Minister in regulations where accessing such information is necessary— | ||
(I) to comply with this Part or end user obligations under the VMP Regulation or the Medicated Feed Regulation, or | ||
(II) having regard to the need to adequately safeguard public or animal health or the environment. | ||
(6) The Minister may make regulations in relation to the operation of the national database including, inter alia— | ||
(a) specifying the information to be recorded on and the manner, method or form of recording information on or transmitting it to, the national database, | ||
(b) determining the form of an electronic prescription or notification of the existence of a prescription on the national database, | ||
(c) if recorded on another database, requiring that the information is transmitted to and from the national database in a readable and compatible form as specified in the regulations, | ||
(d) specifying the period of time within which such prescriptions or dispensing must be recorded or shared with the national database, | ||
(e) providing for the registration on the national database of a person referred to in subparagraph (i), (ii), (iii) or (iv) of paragraph (b) of subsection (5) to access and use it, and | ||
(f) providing for the prescription and dispensing protocols in circumstances as determined by the Minister where the national database is unavailable to users. | ||
(7) The Minister may process information held on the national database for the following: | ||
(a) monitoring, evaluating or reporting the volume of sales, level and frequency of use of veterinary medicinal products or medicated feed or certain classes of such, or in specific animals or in different species of animals in the State; | ||
(b) developing or implementing national or European policy relating to the use of veterinary medicinal products or medicated feed or certain classes of such in specific animals or in different species of animals in the State; | ||
(c) determining the types of diseases or ailments in respect of which specific types of veterinary medicinal products or medicated feed are prescribed or dispensed; | ||
(d) evaluating or determining the persons or class of persons prescribing, dispensing or using veterinary medicinal products or medicated feed or certain classes of such in the State and the level and frequency of prescribing, dispensing or use by such persons; | ||
(e) monitoring or evaluating the scientific justification provided for prescribing veterinary medicinal products or medicated feed or certain classes of such for use in specific animals or in different species of animals; | ||
(f) evaluating or identifying if certain locations in the State are more prevalent to animal diseases or ailments; | ||
(g) the administration, control and enforcement of this Part, the VMP Regulation, the Medicated Feed Regulation or Regulation 625/2017 of the European Parliament and of the Council of 15 March 20173 ; | ||
(h) where processing such information is necessary— | ||
(i) to comply with this Part or end user obligations under the VMP Regulation or the Medicated Feed Regulation, or | ||
(ii) having regard to the need to adequately safeguard public or animal health or the environment. | ||
(8) A person who fails to comply with subsection (2) or (3) commits an offence and is liable on summary conviction to a class A fine. | ||