{"id":19378,"date":"2022-10-10T22:53:13","date_gmt":"2022-10-10T22:53:13","guid":{"rendered":"http:\/\/legalblog.ie\/?p=19378"},"modified":"2023-12-03T22:19:48","modified_gmt":"2023-12-03T22:19:48","slug":"veterinary-medicine-2","status":"publish","type":"post","link":"https:\/\/legalblog.ie\/veterinary-medicine-2\/","title":{"rendered":"Veterinary Medicine"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_63 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title \" >Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/legalblog.ie\/veterinary-medicine-2\/#The_Legislation\" title=\"The Legislation\">The Legislation<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/legalblog.ie\/veterinary-medicine-2\/#Product_Authorisation\" title=\"Product Authorisation\">Product Authorisation<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/legalblog.ie\/veterinary-medicine-2\/#Application\" title=\"Application\">Application<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/legalblog.ie\/veterinary-medicine-2\/#Cross-Border_Sales\" title=\"Cross-Border Sales\">Cross-Border Sales<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/legalblog.ie\/veterinary-medicine-2\/#Various_Licences\" title=\"Various Licences\">Various Licences<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/legalblog.ie\/veterinary-medicine-2\/#Prescription\" title=\"Prescription\">Prescription<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/legalblog.ie\/veterinary-medicine-2\/#Manufacture_Import_Licensing\" title=\"Manufacture &amp; Import Licensing\">Manufacture &amp; Import Licensing<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/legalblog.ie\/veterinary-medicine-2\/#Sales_Channels\" title=\"Sales Channels\">Sales Channels<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/legalblog.ie\/veterinary-medicine-2\/#Companion_Animal_Medicine\" title=\"Companion Animal Medicine\">Companion Animal Medicine<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/legalblog.ie\/veterinary-medicine-2\/#Licence_Requirements\" title=\"Licence Requirements\">Licence Requirements<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/legalblog.ie\/veterinary-medicine-2\/#Merchants_Licence\" title=\"Merchants Licence\">Merchants Licence<\/a><\/li><\/ul><\/nav><\/div>\n<h3><span class=\"ez-toc-section\" id=\"The_Legislation\"><\/span>The Legislation<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>The Legislation in respect of veterinary medicines is broadly similar to that for human medicines.\u00a0 It has now been consolidated at the EU level pursuant to the Directive. Principles of mutual recognition of animal remedies apply within the EU. The Irish regulation is the EU (Animal Remedies) Regulations.\u00a0 The Department of Agriculture administers the regulations.<\/p>\n<p>The Animal Remedies Act is domestic legislation. The Irish Medicines Board (now the Healthcare Products Regulatory Authority)\u00a0 licenses veterinary medicinal products.\u00a0 It maintains the pharmacovigilance system.\u00a0 It grants licences for the manufacture of animal remedies and importation from outside the EU.<\/p>\n<p>Veterinary medical products are substances having properties for treating or preventing disease in animals or substances or combinations which may be used or administered to animals with a view to restoring, correcting, modifying physiological functions or exerting a pharmacological, immunological or metabolic action or to making a medical diagnosis.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Product_Authorisation\"><\/span>Product Authorisation<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Veterinary medicinal products must be authorised before being placed on the market.\u00a0 An animals remedies authorisation includes licences and authorisations under the regulations as well as marketing authorisation under EU law granted under centralised procedure or other documents, registration or licence deemed to be so.<\/p>\n<p>It is an offence to import, possess, sell or supply an animal remedy unless there is an authorisation for that remedy in force.<\/p>\n<p>There are exemptions in respect of<\/p>\n<ul>\n<li>homeopathic animal remedies which are registered before 1993 under prior regulations.<\/li>\n<li>if the Irish Medicines Board (now the Healthcare Products Regulatory Authority) determines that the substance is not within the Directive or<\/li>\n<li>in the case of veterinary products intended for fish, caged birds, homing pigeons, small rodents, parrots and rabbits, kept exclusively as pets; they must not contain substances which require veterinary control.<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"Application\"><\/span>Application<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>There are a number of different mechanisms by which authorisations may be granted for veterinary medicine.\u00a0 An application may be made to the Irish Medicines Board (now the Healthcare Products Regulatory Authority) for a national authorisation.<\/p>\n<p>Details of the characteristics of the product must be given together with data in relation to its efficiency, safety and quality.\u00a0 The Irish Medicines Board (now the Healthcare Products Regulatory Authority) grants or refuses a licence in accordance with the requirements in the Directive.<\/p>\n<p>There are special procedures where an applicant wishes to obtain authorisation in two or more states.\u00a0 Following the grant of authorisation by one state, the holder may apply to one or more states to issue equivalent authorisations<\/p>\n<p>There is a further procedure where there is no existing authorisation.\u00a0 In this case, one state from a number may be chosen as a reference state.\u00a0 A coordinated assessment takes place.<\/p>\n<p>EU Rights<\/p>\n<p>The EU legislation provides for the central authorisation of human and veterinary products.\u00a0 A single application may be made and the authorisation is valid to the EU.\u00a0 The procedure must be followed in respect of certain types of medicine, such as<\/p>\n<ul>\n<li>high-tech medicinal products, particularly those which emanate from bio-technical processes and for veterinary medical processes which are primarily as performance enhancers to promote the growth of treated animals or increase yields in the treated animal.\u00a0 In other cases it is discretionary.<\/li>\n<li>qnew product, which contains a new active substance for products with significant therapeutic, scientific and technical innovation or for immunological products for the treatment of animals\u2019 diseases.<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"Cross-Border_Sales\"><\/span>Cross-Border Sales<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Regulations allow for veterinary practitioners in other states providing cross-border services to supply and administer small quantities of animal remedies, notwithstanding that it is not authorised in Ireland.\u00a0 This is subject to certain conditions.\u00a0 It must be authorised in the state in which the veterinary practitioner is established.<\/p>\n<p>It must be brought into the state in its original packaging and used in a food-producing animal.\u00a0 It must be similar in qualitative and quantitative composition to a remedy authorised in Ireland.<\/p>\n<p>In this case, the vet must inform the owner of the animal of the withdrawal procedure. The quantity must be such as may be expected to be in the possession of a practitioner in terms of daily needs and good practice.\u00a0 It must not exceed five days&#8217; supply.\u00a0 Records are required, which must be retained for five years including particulars of animals treated, date and number of animal, address of persons in charge, details and dosage, duration of treatment.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Various_Licences\"><\/span>Various Licences<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>The Department of Agriculture may issue licences to import, possess, sell or administer \u00a0an animal remedy which is not otherwise authorised.\u00a0 This may be permissible if the animal&#8217;s health status requires this and it is authorised in another state.<\/p>\n<p>It may be permitted in other situations where authorisation is pending in Ireland or before the European Medicines Agency.\u00a0 It may be permitted where immunological remedies are required to deal with a serious disease, in exceptional circumstances where an animal is to be exported outside the EU and there is requirement to use an immunisation remedy authorised in that country.<\/p>\n<p>A licence may be issued to allow an animal remedy to be imported, manufactured, possessed or sold in circumstances where it is not authorised, authorised in certain limited situations.\u00a0 This includes use for a trial in research, supply for education and research and exportation from Ireland, supplied for the purpose of an application to the medical IMV.<\/p>\n<p>The application for authorisation requires the veterinary medicinal product to be tested against criteria of safety, quality, efficiency when used in accordance with the recommended usage, takes accounts of risks to animals, person administering the medicine and others who may consume the medicine from produce of the animals concerned and from the environment.<\/p>\n<p>The Board and other authorities undertake a risk-benefit analysis.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Prescription\"><\/span>Prescription<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>A vet must not prescribe animal remedies to a food producing animal other than in accordance with animal remedies authorisation rules in respect of the relevant type of animal. If there is no treatment available and it is necessary to avoid unacceptable suffering, an unauthorised medicine may be administered.\u00a0 However the medicine to be administered must be available, be one licensed for another condition in the same species, for human use or authorised abroad.<\/p>\n<p>Only if the foregoing cannot be met may be veterinary practitioner prepare \u00a0or prescribe another remedy.\u00a0 Other conditions apply.<\/p>\n<p>A withdrawal period must be prescribed to ensure that food from the animal does not contain residues. Minimum periods are prescribed.\u00a0 Records must be made and retained setting out details of the animal and the substance administered together with reasons and the particulars of withdrawal period.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Manufacture_Import_Licensing\"><\/span>Manufacture &amp; Import Licensing<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>A person may not manufacture, import an animal remedy without being licensed by the Irish Medicines Board (now the Healthcare Products Regulatory Authority).\u00a0 There are a number of limited exceptions including<\/p>\n<ul>\n<li>manufacture in a laboratory engaged in education, research or analysis, manufacture of medicated feed stuff or products in accordance with licence,<\/li>\n<li>importation from a third country for transhipment to another \u00a0EU state<\/li>\n<li>dividing packaging or presenting an animal remedy not pre-prepared by\n<ul>\n<li>a pharmacist to be sold from \u00a0the pharmacy,<\/li>\n<li>a veterinary practitioner to be supplied by him for treatment for treatment of an animal under his care<\/li>\n<li>certain sales from an animal remedies merchant licence premises<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>An applicant for a manufacture\u2019s licence must show that they have sufficient premises, technical equipments, human resources to manufacture, control and store the remedies and substances.\u00a0 They must show that manufacturing will take place in accordance with the relevant guidelines and principles.\u00a0 The services of at least one qualified person fulfilling requirements applicable must be available. The HPRA must determine the application within 90 days.<\/p>\n<p>The manufacturer licence must keep records of incoming and outgoing remedies manufactured, sold or supplied.\u00a0 They must include details of the date, type of remedy, batch number and expiry date, quantities, names of recipients.<\/p>\n<p>Records must be maintained and available for inspection by an authorised officer for at least five years or one year after the expiry date whichever is longer.<\/p>\n<p>The licence remains in force for three years or shorter if specified.\u00a0 They must be renewed.\u00a0 Once renewed the validity is for an unlimited period.\u00a0 It may however be revoked, suspended or varied if the remedy is not being manufactured, appropriately.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Sales_Channels\"><\/span>Sales Channels<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Animal remedies may only be sold through a number of outlets or channels.\u00a0 The permitted channels are relative to the medicine concerned.<\/p>\n<p>Veterinary practitioner only, medicines are those which must only be sold or supplied by a vet or by a practitioner to an animal under his care, VPO-1.<\/p>\n<p>A second category VPO-2 are remedies which may be sold only by a veterinary practitioner and administered by the practitioner or by a person in his presence or under his direct supervision to an animal in his care.<\/p>\n<p>Prescription only, are those which may be sold<\/p>\n<ul>\n<li>by a pharmacist in accordance with a prescription from a vet<\/li>\n<li>a registered veterinary practitioner for an \u00a0animal under his care and he has issued a veterinary prescription.<\/li>\n<li>A responsible person from a premise in which animal remedy merchant licence relates in accordance with a veterinary prescription in the case of certain animal remedies.<\/li>\n<\/ul>\n<p>There are a number of other categories of animal remedies.\u00a0 Prescription only exempt, are remedies which may be sold by a pharmacist from a pharmacy or a registered practitioner where the animal is under his care.\u00a0 Pharmacy only remedies are those which may only be supplied from a pharmacy under the personal supervision of a pharmacist or registered veterinary practitioner for an animal under his care.<\/p>\n<p>A licensed merchant remedy is animal remedy which may be sold only for a pharmacy or from a premises for which an animal remedy\u2019s licence relates.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Companion_Animal_Medicine\"><\/span>Companion Animal Medicine<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>A companion animal medicine is an animal remedy which can be provided from a pharmacy, registered veterinary practitioner or from premises in which an animal remedies merchant licence is held or premises to which a companion animal medicine seller\u2019s registration is enforced.<\/p>\n<p>A person may not sell a companion animal medicines unless registered in the companion animal medicine sellers register maintained by the Department of Agriculture.\u00a0 The requirements do not apply to pharmacists, veterinary practitioners, licensed merchants or holders of animal remedies wholesaler\u2019s licence.<\/p>\n<p>Sellers of companion animal medicines must comply with storage requirements.\u00a0 They must have arrangements to receive in return unused and expired remedies. A sale other than accordance with the above conditions is unlawful.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Licence_Requirements\"><\/span>Licence Requirements<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>A person may not sell or supply a remedy unless he has an animal remedies wholesaler\u2019s licence, merchant\u2019s licence or is registered in the companion animal medicine seller\u2019s register.\u00a0 The sale or supply of animal remedies by or under the supervision of a pharmacist from a pharmacy, by a veterinary surgeon in respect of animal under his care or by wholesale by a person who has manufactured them under a manufacture\u2019s licence is permitted.<\/p>\n<p>A premises may not be used for the sale or supply of animal remedies or for storage unless it is either a \u00a0pharmacy registered for a manufacture\u2019s licence, a wholesale licence or merchant\u2019s licence registered in the companion animal medicine seller\u2019s register used by a veterinary surgeon for veterinary practice.<\/p>\n<p>Generally, animal remedies may not be sold remotely or by mail order, travelling shops, vending machines etc.\u00a0 Licences may be granted to permit merchants and pharmacist to sell certain medicines by e-mail or internet.<\/p>\n<p>Licence holders must have suitable premises, equipment and staff arrangements to preserve and prevent the deterioration of remedies.\u00a0 Changes in the premises must be notified to the Minister.\u00a0 There must be suitable procedures and facilities for storage, maintenance of records, handling of stocks.\u00a0 There must be appropriate withdrawal and recall procedures.<\/p>\n<p>Records must be kept of all incoming and outgoing transactions including transaction dates, details of the remedy, manufacturer\u2019s batch number, particulars of supplier or consignee, quantity. The records must be maintained for five years and may be inspected by authorised officer.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Merchants_Licence\"><\/span>Merchants Licence<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>An animal remedies merchant\u2019s licence is granted by the Department of Agriculture.\u00a0 It permits the sale or supply of certain animal remedies generally and others in accordance with a designated route of supply or prescription.\u00a0 The licence is valid for three years.<\/p>\n<p>The same provisions as apply both in respect of an animal remedies wholesaler\u2019s licence, apply.\u00a0 Requirements in respect of premises, stock handling records and sales apply.\u00a0 Licence holders must have sessions to receive back unused and expired products.\u00a0 Customers must be notified of the facility.<\/p>\n<p>Remedies may only be sold by a responsible person.\u00a0 The Minister may approve training requirements for responsible persons and certification of training for proper handling and storage of medicine.<\/p>\n<!--themify_builder_content-->\n<div id=\"themify_builder_content-19378\" data-postid=\"19378\" class=\"themify_builder_content themify_builder_content-19378 themify_builder tf_clear\">\n    <\/div>\n<!--\/themify_builder_content-->\n","protected":false},"excerpt":{"rendered":"<p>The Legislation The Legislation in respect of veterinary medicines is broadly similar to that for human medicines.\u00a0 It has now been consolidated at the EU level pursuant to the Directive. Principles of mutual recognition of animal remedies apply within the EU. The Irish regulation is the EU (Animal Remedies) Regulations.\u00a0 The Department of Agriculture administers [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"footnotes":""},"categories":[263,141],"tags":[],"_links":{"self":[{"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/posts\/19378"}],"collection":[{"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/comments?post=19378"}],"version-history":[{"count":5,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/posts\/19378\/revisions"}],"predecessor-version":[{"id":29777,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/posts\/19378\/revisions\/29777"}],"wp:attachment":[{"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/media?parent=19378"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/categories?post=19378"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/tags?post=19378"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}