{"id":10351,"date":"2022-07-11T22:56:08","date_gmt":"2022-07-11T22:56:08","guid":{"rendered":"http:\/\/legalblog.ie\/advertising-of-medicines\/"},"modified":"2024-02-24T22:17:47","modified_gmt":"2024-02-24T22:17:47","slug":"advertising-of-medicines","status":"publish","type":"post","link":"https:\/\/legalblog.ie\/advertising-of-medicines\/","title":{"rendered":"Advertising of Medicines"},"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\/advertising-of-medicines\/#Advertising\" title=\"Advertising\">Advertising<\/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\/advertising-of-medicines\/#Advertisement_Requirements\" title=\"Advertisement Requirements\">Advertisement Requirements<\/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\/advertising-of-medicines\/#Advertisments_to_Public\" title=\"Advertisments to Public\">Advertisments to Public<\/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\/advertising-of-medicines\/#Herbal_Homoeopathic\" title=\"Herbal &amp; Homoeopathic\">Herbal &amp; Homoeopathic<\/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\/advertising-of-medicines\/#Advertising_to_Medical_Professionals\" title=\"Advertising to Medical Professionals\">Advertising to Medical Professionals<\/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\/advertising-of-medicines\/#Promotional_Matters\" title=\"Promotional Matters\">Promotional Matters<\/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\/advertising-of-medicines\/#Sales_Representatives\" title=\"Sales Representatives\">Sales Representatives<\/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\/advertising-of-medicines\/#Promotional_to_Public\" title=\"Promotional to Public\">Promotional to Public<\/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\/advertising-of-medicines\/#Misc_Matters\" title=\"Misc. Matters\">Misc. Matters<\/a><\/li><\/ul><\/nav><\/div>\n<h3><span class=\"ez-toc-section\" id=\"Advertising\"><\/span>Advertising<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Advertising of medicines is regulated under EU-derived legislation.\u00a0 It is also subject to general legislation and codes of practice on advertising.<\/p>\n<p>Advertising includes any form of promotion, canvassing or inducement.\u00a0 It includes advertising to the general public and to persons entitled to prescribe. It also covers;<\/p>\n<ul>\n<li>visits by sales representatives,<\/li>\n<li>provision of samples,<\/li>\n<li>sponsorships or promotional meetings attended by persons entitled to prescribe, sponsorship of congresses, seminars etc.,<\/li>\n<li>provision of inducements to prescribe or supply medicinal products by gifts, bonuses in money or in kind.<\/li>\n<\/ul>\n<p>The legislation does not apply to the following:<\/p>\n<ul>\n<li>Labelling and Package Leaflet (which are subject to other very specific controls).<\/li>\n<li>Correspondence with material of a non-promotional nature, answering specific queries about products,<\/li>\n<li>factual informative announcements relating to ongoing matters such as warnings, catalogues, price lists and changes.<\/li>\n<li>books and journals containing advertising, imported into Ireland, are not aimed at intended or directed to people resident in the State.<\/li>\n<li>Information in relation to human health and disease without reference to particular medicinal products.<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"Advertisement_Requirements\"><\/span>Advertisement Requirements<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>A medicinal product may only be advertised by an entity with a marketing authorisation or certain other equivalent registrations and permits.\u00a0 The advertisement must comply with the product\u2019s summary of product characteristics (SPC) currently in place.\u00a0 Accordingly, new developments may not be published until they are updated and included in the SPC.<\/p>\n<p>Certain categories of medicines may not be advertised to the public, including<\/p>\n<ul>\n<li>prescription-only medicines,<\/li>\n<li>certain classes of substances whether or not requiring a prescription.<\/li>\n<\/ul>\n<p>Advertising may be allowed as part of public health campaigns for vaccines undertaken or approved by the Department of Health.<\/p>\n<p>The terms of authorisations of a medicine may restrict advertising of non-prescription medicines.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Advertisments_to_Public\"><\/span>Advertisments to Public<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>In the case of advertisements that may be made to the general public, further restrictions apply.\u00a0 They must not give information, giving the impression that medical consultation is unnecessary. \u00a0They should not offer diagnosis or suggest methods of treatment by post, e-mail etc. \u00a0They must not suggest the effects of the medicine are guaranteed and do not have adverse reactions.<\/p>\n<p>They must not suggest that health can be enhanced by taking the product.\u00a0 They must not suggest health could be affected by not taking the product.\u00a0 They must not be directed exclusively or principally at children.\u00a0 They must not refer to scientific recommendations by health professionals or celebrities, which could encourage consumption.<\/p>\n<p>They must not suggest that the product is a foodstuff, cosmetic or other product.\u00a0 They must not suggest the safety or efficacy is due to the fact that it is natural.\u00a0 They must not set out representations of particular case histories, which may lead to erroneous diagnoses.\u00a0 They must not make alarming or misleading claims of recovery or use terms or images of changes in the human body caused by disease or injury or the action of a product on the human body.<\/p>\n<p>It must be clear that the message is an advertisement.\u00a0 The product must be clearly identified as a medicinal product. Certain information must appear in the advertisement, including<\/p>\n<ul>\n<li>name of the product,<\/li>\n<li>if there is only one active ingredient, the common or generic name.<\/li>\n<li>information necessary for correct use<\/li>\n<li>invitation to read carefully the instructions on the package or label or leaflet.<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"Herbal_Homoeopathic\"><\/span>Herbal &amp; Homoeopathic<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>In the case of traditional herbal medicines, certain specific indications are required.<\/p>\n<p>Advertising by way of reminder, which makes no claims or indications and refers to the product only, must only contain certain minimal details, including in particular the product\u2019s international non-proprietary name, if it exists or trade mark, and advice to read carefully the instructions on the leaflet contained in the package or label.<\/p>\n<p>Homeopathic medicines may not state any claim on their labelling. The labelling or package insert \u00a0must contain<\/p>\n<ul>\n<li>certain wording, including the words &#8220;homeopathic medicinal product&#8221;,<\/li>\n<li>the scientific name, followed by the degree of dilution;<\/li>\n<li>name and address of the holder of the certificate of registration;<\/li>\n<li>method of administration;<\/li>\n<li>expiry date;<\/li>\n<li>contents of sales presentations;<\/li>\n<li>storage precautions;<\/li>\n<li>batch number;<\/li>\n<li>registration number;<\/li>\n<li>advice to consult a doctor if symptoms persist.<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"Advertising_to_Medical_Professionals\"><\/span>Advertising to Medical Professionals<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>There are specific requirements for advertisements aimed at persons who are qualified to prescribe.\u00a0 They must include:<\/p>\n<ul>\n<li>essential information compatible with the SmPC;<\/li>\n<li>name of product and list of active ingredients besides the product name; classification for sale and supply of the product, e.g., prescription only;<\/li>\n<li>indications of a marketing authorization or certificate of traditional use registration;<\/li>\n<li>details of adverse reactions,<\/li>\n<li>precautions per the SmPC;<\/li>\n<li>dosage and method of use;<\/li>\n<li>name and address of authorisation holder;<\/li>\n<li>marketing authorisation particulars;<\/li>\n<\/ul>\n<p>There are certain further requirements regarding traditional herbal medicine products.\u00a0There are requirements regarding the position, location and prominence of certain of the details.<\/p>\n<p>Reminder advertisements may contain prescribed but lesser information.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Promotional_Matters\"><\/span>Promotional Matters<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Promotional aides are non-monetary gifts relevant to the practice of medicine and pharmacy for the purpose of promotion.\u00a0 They may only include names of the product or its international non-proprietary name or trade mark.<\/p>\n<p>It must be intended only as a reminder and be supplied to persons qualified to prescribe medicinal products.\u00a0 They might cover such things as pens and equivalent small, inexpensive items.<\/p>\n<p>Written promotional material provided to persons qualified to prescribe must include, as a minimum, essential information in accordance with the SmPC classification and the date of the document. The information must be accurate, up-to-date, and sufficiently complete to enable the recipient to form a opinion as to the value of the medicine.\u00a0 Quotations must be taken from recognized scientific journals and works and must be accurately reproduced.<\/p>\n<p>Hospitality may be offered to persons entitled to prescribe at promotional events, including conferences and professional and scientific events, provided that the hospitality is at a reasonable level limited to the main purposes or scientific objectives of the event and is not extended to non-health professionals, including families of health professionals.<\/p>\n<p>Health professionals may not elicit or accept, prohibit inducements, sponsorship etc. This is not to prejudice the negotiation of prices and discounts, etc., in the ordinary course of business.\u00a0 They must be reflected in the relevant sales invoice.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Sales_Representatives\"><\/span>Sales Representatives<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>There are requirements in relation to the conduct and training of certain persons, including medical sales representatives.\u00a0 They must have a copy of the SmPC for each product promoted, or it must be included in a reference publication delivered within the last 12 months to the relevant group of health professionals.<\/p>\n<p>The representatives should draw the health professional\u2019s attention to the relevant entries in the compendium or reference publication.\u00a0 Representatives must report back on information about the use of products obtained during the visits, including, in particular, any adverse reaction.<\/p>\n<p>Authorisation holders are responsible for the representatives.\u00a0 They must ensure they have adequate training and scientific knowledge.\u00a0 The regulator may require specific training. The relevant SmPCs must be available.<\/p>\n<p>Gifts, monetary payments or benefit in kinds supplied or offered in the course of promoting medical products must be inexpensive and relevant to the practice of medicine or pharmacy.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Promotional_to_Public\"><\/span>Promotional to Public<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Pharmaceutical companies, manufacturers, wholesalers, etc. must not sell or supply medicines to the public for promotional purposes.\u00a0 Free samples may be given to persons entitled to prescribe but not pharmacists, subject to certain conditions.<\/p>\n<p>A Sample may be provided on an exceptional basis for the purpose of gaining experience. There is a maximum of six samples per year.\u00a0 There must be a written request for the sample.\u00a0 There must be adequate systems of control and accountability.<\/p>\n<p>The pack must be no larger than the smallest pack available on the market.\u00a0 It must be labelled, &#8220;free sample, not for sale.&#8221;\u00a0 It must be accompanied by the relevant SmPC or it must have been furnished within the previous 12 months.<\/p>\n<p>Marketing authorisation holders and equivalents must maintain a scientific survey to compile and create information in relation to products received from any source.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Misc_Matters\"><\/span>Misc. Matters<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Advertising material must be retained together with particulars of dates and channels of distribution.\u00a0 This must be provided to the regulator as required.<\/p>\n<p>Self-regulatory advertising codes of practice may be approved. They may go wider than those matters dealt with in regulation.\u00a0 They may include cure activities and dealings with various organisations&#8217; e-mail advertising.\u00a0 There are a number of codes that operate beyond the statutory positions.<\/p>\n<p>Breach of self-regulatory codes may be prosecuted under the Medicines Board legislation.\u00a0 Orders may be given to withdraw misleading advertisements or publish corrective statements.<\/p>\n<!--themify_builder_content-->\n<div id=\"themify_builder_content-10351\" data-postid=\"10351\" class=\"themify_builder_content themify_builder_content-10351 themify_builder tf_clear\">\n    <\/div>\n<!--\/themify_builder_content-->\n","protected":false},"excerpt":{"rendered":"<p>Advertising Advertising of medicines is regulated under EU-derived legislation.\u00a0 It is also subject to general legislation and codes of practice on advertising. Advertising includes any form of promotion, canvassing or inducement.\u00a0 It includes advertising to the general public and to persons entitled to prescribe. It also covers; visits by sales representatives, provision of samples, sponsorships [&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":[141],"tags":[],"_links":{"self":[{"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/posts\/10351"}],"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=10351"}],"version-history":[{"count":3,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/posts\/10351\/revisions"}],"predecessor-version":[{"id":32223,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/posts\/10351\/revisions\/32223"}],"wp:attachment":[{"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/media?parent=10351"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/categories?post=10351"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/tags?post=10351"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}