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Veterinary Medicine & Residues
From Department of Agriculture, Food and the Marine
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The Department of Agriculture, Food and the Marine (the Department) is responsible for the implementation of controls in relation to veterinary medicines the purpose of which is to safeguard public health and animal health and welfare. REGULATION (EU) 2019/6 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC sets down a legislative basis for the licensing of veterinary medicines and controls on their distribution. Under this regime, the Health Products Regulatory Authority (HPRA) are the national licensing authority responsible for veterinary medicines, while the Department is responsible for the licensing of premises engaged in the commercial distribution of veterinary medicines. All veterinary medicinal products intended for use must be authorised in the State and can only be used in accordance with the conditions attached to the product authorisation.
There are currently 1,915 individual products licensed with HPRA and a number of Special Import Licences in accordance with the requirements of EU legislation. In addition, there are 94 wholesale and approx. 820 retail premises regulated and licensed in accordance with REGULATION (EU) 2019/6. All premises have been inspected by the Department to ensure that they reach the required standard.
The manufacture, distribution, and sale of medicated feedingstuffs and intermediate products is also subject to licensing by the Minister under REGULATION (EU) 2019/4 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 December 2018.The use of medicated feedingstuffs is prohibited except under and in accordance with the terms of a veterinary prescription issued by a registered veterinary practitioner. Medicated pre-mixes must be authorised by the HPRA. There are approximately 20 licensed medicated feed manufacturers and 34 home mixers licensed to manufacture medicated feed in Ireland
Application by a holder of a Wholesale Distribution Authorisation to import an Immunological Veterinary Medicinal Product in accordance with Article 110 of EU 2019/6 – From 3rd Country Only
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Application by a Veterinary Practitioner or a holder of a Wholesale Distribution Authorisation for an import licence in accordance with Articles 112,113 or 114 of Regulation EU 2019/6
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Application by a Veterinary Practitioner or a holder of a Wholesale Distribution Authorisation for an import licence for an Essential Substance as listed in the Annex to EU Regulation (EU) 122/2013 for the treatment of equidae
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Application for a Companion Animal Medicine Seller’s Registration
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Application for a Licence to sell Veterinary Medicinal Products via the Internet
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Application for a Veterinary Medicinal Product Retailers Licence to Solicit Orders
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Application for a Veterinary Medicinal Product Retailers Licence
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Application for a Veterinary Medicinal Product Wholesale Distribution Authorisation
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Application by a Feed Business Operator for a licence to import a medicated feedingstuff for own use
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Application by a Feed Business Operator for an authorisation to manufacture medicated feedingstuffs and intermediate products
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Protocol for notifying shortages of Veterinary Medicinal products
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Industry Notification of anticipated Veterinary Medicine Product Shortage
Formal ‘Industry Notification’ of anticipated Veterinary Medicine Product Shortage
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Sector Notification Form of Veterinary Medicine Product Shortage
Formal Notification by End-User (Farmer, Veterinary Inspector, Pharmacist, Licenced Merchant) of Veterinary Medicine Product Shortage
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HPRA Notification of anticipated Veterinary Medicine Product Shortage
Formal HPRA Notification’ of anticipated Veterinary Medicine Product Shortage
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Advertising or Promotion of Veterinary Medicinal Products Information Note
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Information for Compound Mills - Medicated Feed Regulation EU 2019/4
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Essential Substances for the Treatment of Horses - The Responsibilities of Equine Veterinary Practitioners
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Responsibilities of Horse Owners/Person in charge of Horses
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Each year the Department implements the National Residue Control Plan (NRCP). The NRCP is one of a range of measures implemented by the Department designed to safeguard consumers from exposure to illegal residues and to meet the requirements laid down by EU law. Under Council Directive 96/23/EC all Member States are required to implement residue surveillance plans and to submit their programmes annually to the European Commission for approval. The legal basis for the NRCP in Ireland is provided for by the European Communities (Control of Animal Remedies and their Residues) Regulations, 2009 (S.I. No. 183 of 2009). Third Countries wishing to export animal products to the EU are similarly required to satisfy the European Commission that their residue surveillance measures provide equivalent guarantees for EU consumers.
Implementation of the Plan involves taking samples from food producing species both at farm and primary processing plant levels. Samples are taken in accordance with criteria designed to target animals or products, which are more likely to contain illegal residues. However, the results also reflect the outcome of sampling conducted in specific cases where the presence of illegal residues was suspected by Department inspectors, for example, on the basis of the ante or post-mortem examinations of animals at slaughterhouses. Where a positive result is detected in the laboratory, a follow-up investigation is conducted at the farm of origin with a view to taking the necessary enforcement measures up to and including legal action, where appropriate.
During 2017, for example, just over 18,500 samples were taken nationally from eight food-producing species as well as from milk, eggs and honey. Tests were carried out at officially approved laboratories covering 18 distinct residue groupings (each residue grouping is in turn comprised of a number of sub-groups). The residue groupings fall into three broad categories: banned substances, such as growth-promoting hormones and beta-agonists; illegal residues of approved veterinary medicines (these usually arise where animals enter the food chain before expiry of the prescribed withdrawal period for the medicine concerned); and environmental contaminants.
The effectiveness of the NRCP and enforcement measures coupled with the efforts of the industry over many years has seen low levels of detected positives in recent years. Taking all groups and species into account, the incidence of positive results in 2017, was 0.3%, this is in line with the reduced levels detected in recent years (0.2% in 2016, 0.18% in 2015 and 0.22% in 2014). The Department publishes the detailed results of residue monitoring on an on-going basis annually.
Since 2000, the NRCP has been complemented by a legislatively-based regime under which meat and milk processors are obliged to implement their own residue monitoring measures in respect of animals or milk supplied to them. This involves each processor submitting, annually, to the Department a residue monitoring plan (for approval). Where animals test positive it makes it mandatory for the processor to apply significantly increased levels of testing (up to a level of 100%) to subsequent consignments of animals from the supplier in question. This initiative significantly increases the protection from illegal residues afforded to consumers of Irish food products. It also enables each processor and, indeed supplier, to deal effectively and in a timely manner with any problems which might from time to time emerge and equips Irish processors with another valuable and credible means of assuring consumers in an increasingly competitive marketplace of the quality and safety of their products.
Control plan reports for 2010 to 2018 are available Here
Further information on residue surveillance and associated matters can be obtained from
Veterinary Medicines Section
Address:
Floor 1, Block B, Administration Building, Backweston, Youngs Cross
, Celbridge
, Co. Kildare
Phone number:
The Veterinary Council of Ireland is an independent statutory body set up under the Veterinary Practice Act 2005, as amended. The Veterinary Council operates under the aegis of the Minister for Agriculture, Food and the Marine.
The principal function of the Veterinary Council is to regulate the practice of veterinary medicine and veterinary nursing in Ireland, in the interest of animal health and welfare, and veterinary public health, in the public interest. http://www.vci.ie/
Review of the Governance Arrangements of the Veterinary Council of Ireland Report
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Information on the new EU Regulations on Veterinary Medicines and Medicated Feed can be found here .
The Department of Agriculture, Food and the Marine (DAFM) and the Health Products Regulatory Authority (HPRA) are the competent authorities for the purpose of this Regulation.
The role of the HPRA in relation to veterinary medicinal products is to ensure that medicines are of good quality, that they are safe and effective. They review applications for marketing authorisation and ensure that the medicines comply with the regulatory standards and relevant legislation. They review the benefit / risk balance of products on an ongoing basis by means of pharmacovigilance monitoring.
DAFM regulate activities relating to the wholesale, retail and the use of veterinary medicines, as well as legislate nationally in respect of the conditions that must be fulfilled for the prescribing, dispensing, use and disposal of veterinary medicines in Ireland.
The Regulation applies in the European Union on 28 January 2022 and sets out rules for the sale, manufacture, import, export, supply, distribution, advertisement, control and use of veterinary medicinal products, aiming to:
- modernise legislation;
- stimulate innovation in and increase the availability of veterinary medicinal products; and
- strengthen the EU’s campaign against antimicrobial resistance.
The main objectives of the new Regulation are to:
- simplify the regulatory environment and reduce the administrative burden for pharmaceutical companies developing veterinary medicines, for example through streamlined pharmacovigilance rules;
- stimulate the development of innovative veterinary medicines, including products for small markets (minor use and minor species);
- improve the functioning of the internal market for veterinary medicines;
- strengthen EU action to fight antimicrobial resistance through specific measures ensuring prudent and responsible use of antimicrobials in animals, including reserving certain antimicrobials for the treatment of infections in humans in line with a ‘One Health’ approach for the benefit of animal and public health and every EU citizen.
Commission Implementing Regulation (EU) 2022/1255 of EU 2019/6 of the European Parliament and of the Council on antimicrobials reserved for human use
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Information for Veterinary Practitioners on EU Regulation 2019/6 on Veterinary Medicinal Products (VMP) and EU Regulation 2019/4 on Medicated Feed
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