{"id":1872,"date":"2020-12-24T07:53:53","date_gmt":"2020-12-23T21:53:53","guid":{"rendered":"https:\/\/nz.legalvision.com.au\/?p=1872"},"modified":"2021-02-23T10:28:45","modified_gmt":"2021-02-22T21:28:45","slug":"therapeutic-product","status":"publish","type":"post","link":"https:\/\/legalvision.co.nz\/regulatory-and-compliance\/therapeutic-product\/","title":{"rendered":"Therapeutic Product Regulation in New Zealand"},"content":{"rendered":"\n<p><span style=\"font-weight: 400\">There are a number of regulatory requirements for importing, distributing or otherwise supplying therapeutic products in New Zealand. If you are thinking about importing or supplying a therapeutic product in New Zealand, make sure that: <\/span><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><span style=\"font-weight: 400\">your product is compliant with New Zealand laws; and <\/span><\/li><li><span style=\"font-weight: 400\">you are aware of your legal requirements as the product sponsor.&nbsp;<\/span><\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span style=\"font-weight: 400\">Current <\/span><span style=\"font-weight: 400\">Therapeutic Product <\/span><span style=\"font-weight: 400\">Regulation&nbsp;<\/span><\/h2>\n\n\n\n<p><span style=\"font-weight: 400\">In New Zealand, there are certain requirements for approval, classification, manufacture, sale, distribution, advertising, prescribing and dispensing of therapeutic products. The body responsible for administering the regulatory framework in New Zealand is the New Zealand Medicines and Medical Devices Safety Authority (Medsafe). Medsafe works to ensure therapeutic products are of an acceptable standard of safety, quality and efficacy.&nbsp;<\/span><\/p>\n\n\n\n<p><span style=\"font-weight: 400\">Some therapeutic products, such as narcotic and psychotropic products, are classified as <\/span><i><span style=\"font-weight: 400\">controlled drugs<\/span><\/i><span style=\"font-weight: 400\">. These products face other legal regulations.&nbsp;<\/span><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span style=\"font-weight: 400\">What Is a Therapeutic Product?<\/span><\/h2>\n\n\n\n<p><span style=\"font-weight: 400\">A therapeutic product includes medicines, medical devices and other related products. Therapeutic products are products f<\/span>or use<span style=\"font-weight: 400\"> in or on humans for a therapeutic purpose. Therapeutic purpose means (as well as meaning a purpose in connection with any of the following):&nbsp;<\/span><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li style=\"font-weight: 400\"><span style=\"font-weight: 400\">preventing, diagnosing, monitoring, alleviating, treating, curing, or compensating for a disease, ailment, defect or injury;<\/span><\/li><li style=\"font-weight: 400\"><span style=\"font-weight: 400\">influencing, inhibiting or modifying a physiological process;<\/span><\/li><li style=\"font-weight: 400\"><span style=\"font-weight: 400\">testing the susceptibility of persons to a disease or ailment;<\/span><\/li><li style=\"font-weight: 400\"><span style=\"font-weight: 400\">influencing, controlling, or preventing conception;<\/span><\/li><li style=\"font-weight: 400\"><span style=\"font-weight: 400\">testing for pregnancy; or&nbsp;<\/span><\/li><li style=\"font-weight: 400\"><span style=\"font-weight: 400\">investigating, replacing, or modifying parts of the human anatomy.&nbsp;&nbsp;<\/span><\/li><\/ul>\n\n\n\n<p><span style=\"font-weight: 400\">Your product may be a therapeutic product if you claim or imply a therapeutic purpose for the product. For instance, this could be via a claim on the product labelling.<\/span><\/p>\n\n\n\n<div class=\"box box--info box--icon\">\n<p><span style=\"font-weight: 400\">For example, an e-cigarette product that makes therapeutic purpose claims, such as \u201csupports or aids smoking cessation\u201d, will be considered a therapeutic product.<\/span><\/p>\n<\/div>\n\n\n\n<p>The regulation exempts c<span style=\"font-weight: 400\">ertain products and product types i<\/span>f<span style=\"font-weight: 400\"> <\/span>you meet <span style=\"font-weight: 400\">certain conditions. For example, this includes oral hygiene products like toothpaste or mouthwash. T<\/span>he Medicines Act does not regulate <span style=\"font-weight: 400\">oral hygiene products, provided that: <\/span><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><span style=\"font-weight: 400\">such products do not contain a substance which is a scheduled medicine; and <\/span><\/li><li><span style=\"font-weight: 400\">any claimed benefits from the use of the product only relate to improvements in oral hygiene and prevention of tooth decay.&nbsp;<\/span><\/li><\/ul>\n\n\n\n\n<a href=\"#content-next\"\n   class=\"block p-4 mt-10 text-xl font-bold text-center text-white no-underline bg-gray-800 rounded-t-xl\">\n    Continue reading this article below the form\n    <i class=\"text-xl fa-regular fa-arrow-down\"><\/i>\n<\/a>\n<div class=\"px-6 pt-10 pb-12 mb-10 text-center bg-gray-100 rounded-b-xl sm:px-12 test\">\n    <div class=\"mb-8 text-2xl font-bold text-orange\">\n        Need legal advice?\n        <br>\n        <span class=\"text-lg not-prose\">\n                            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These categories are:&nbsp;<\/span><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li style=\"font-weight: 400\"><span style=\"font-weight: 400\">prescription medicines;<\/span><\/li><li style=\"font-weight: 400\"><span style=\"font-weight: 400\">restricted medicines; and<\/span><\/li><li style=\"font-weight: 400\"><span style=\"font-weight: 400\">pharmacy-only medicines.<\/span><\/li><\/ul>\n\n\n\n<p><span style=\"font-weight: 400\">Prescription medicines are medicines that can only be sold, supplied or administered in accordance with a prescription given by an authorised prescriber. An authorised prescriber could be a nurse practitioner, medical practitioner or dentist.<\/span><\/p>\n\n\n\n<p><span style=\"font-weight: 400\">Restricted medicines are medicines that y<\/span>ou may sell<span style=\"font-weight: 400\"> without a prescription. However, only a registered pharmacist in a pharmacy can sell them.&nbsp;<\/span><\/p>\n\n\n\n<p><span style=\"font-weight: 400\">Pharmacy-only medicines are medicines that y<\/span>ou <span style=\"font-weight: 400\">may<\/span> sell<span style=\"font-weight: 400\"> in:<\/span><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><span style=\"font-weight: 400\">community or hospital pharmacies; or <\/span><\/li><li><span style=\"font-weight: 400\">a shop in an isolated area that <\/span>has a<span style=\"font-weight: 400\"> license to sell that particular medicine. <\/span><\/li><\/ul>\n\n\n\n<p><span style=\"font-weight: 400\">Any salesperson can sell pharmacy-only medicines.&nbsp;<\/span><\/p>\n\n\n\n<p><span style=\"font-weight: 400\">Some herbal remedies are also regulated as medicines under the Medicines Act. Herbal remedies do not contain prescription, restricted or pharmacy-only ingredients.&nbsp;<\/span><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span style=\"font-weight: 400\">Related Products<\/span><\/h2>\n\n\n\n<p><span style=\"font-weight: 400\">A related product is a product that is a food, dentifrice or cosmetic product that is claimed to be effective for a therapeutic purpose. <\/span><\/p>\n\n\n\n<div class=\"box box--info box--icon\">\n<p><span style=\"font-weight: 400\">For example, certain vitamin supplements and antiseptic throat lozenges are related products.&nbsp;<\/span><\/p>\n<\/div>\n\n\n\n<p><span style=\"font-weight: 400\">Antiperspirants, most moisturisers, anti-wrinkle and anti-ageing products which have a superficial cosmetic effect (and not physiological effect) and general use antiseptics are all cosmetic products. You do not need consent to distribute these products in New Zealand.&nbsp;<\/span><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span style=\"font-weight: 400\">Medical Devices<\/span><\/h2>\n\n\n\n<p><span style=\"font-weight: 400\">A medical device is any device, instrument, apparatus or appliance that is intended to be used primarily on human beings for a therapeutic purpose.<\/span> This is<span style=\"font-weight: 400\"> provided it does not achieve its principal intended action by pharmacological, immunological, or metabolic means.<\/span><\/p>\n\n\n\n<p><span style=\"font-weight: 400\">Currently, medical devices d<\/span>o not have <span style=\"font-weight: 400\">strict regula<\/span>tions<span style=\"font-weight: 400\"> in New Zealand. Unlike medicines and related products, the only requirement for supply of a medical device in New Zealand is to file an online notification via the Web Assisted Notification of Devices (WAND) portal. <\/span>The New Zealand sponsor of the medical device must file a<span style=\"font-weight: 400\"> WAND notification<\/span> <span style=\"font-weight: 400\">and must include details such as the:&nbsp;<\/span><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li> risk classification of the device; <\/li><li> name of the manufacturer and sponsor of the device (together with their relevant business addresses and contact details); and&nbsp; <\/li><li> product description attributed to the device by the Global Medical Device Nomenclature System.&nbsp; <\/li><\/ul>\n\n\n\n<p><span style=\"font-weight: 400\">The government has been working to develop a new regulatory framework for therapeutic goods, which would look to replace the existing Medicines Act and more fully regulate medical devices in New Zealand.&nbsp;<\/span><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Distributing or Supplying Medicines and Related Products in New Zealand<\/h2>\n\n\n\n<p><span style=\"font-weight: 400\">You must obtain consent from the Minister of Health before you can distribute, sell or advertise your medicine or related product in New Zealand. You must:&nbsp;<\/span><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li> submit an application for consent to Medsafe; and&nbsp; <\/li><li> comply with the requirements of the Medicines Act.&nbsp; <\/li><\/ul>\n\n\n\n<p><span style=\"font-weight: 400\">Medsafe will make an initial assessment to ensure that you have: <\/span><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><span style=\"font-weight: 400\">submitted your application in the correct category; and <\/span><\/li><li><span style=\"font-weight: 400\">provided all the required data. <\/span><\/li><\/ul>\n\n\n\n<p><span style=\"font-weight: 400\">The application will then progress to the evaluation phase. In this phase, Medsafe will determine that your application sufficiently demonstrates the safety, quality and efficacy of your product and that the benefits outweigh the risk of harm to the patient. If this phase is successful, Medsafe will recommend that the Minister should grant consent.&nbsp;<\/span><\/p>\n\n\n\n<p><span style=\"font-weight: 400\">The New Zealand resident manufacturer or importer of a therapeutic product is the \u201csponsor\u201d for the product. As the sponsor, you are responsible for ensuring the therapeutic product is compliant with New Zealand laws, including in relation to advertising and promotion, undertaking product recalls and withdrawals and reporting adverse reactions.<\/span><\/p>\n\n\n\n<p><span style=\"font-weight: 400\">Sometimes a patient may require treatment by a medicine that has not been approved for use or supply in New Zealand. Access may be provided to such unapproved medicines via special pathways, such as a clinical trials scheme, compassionate use supply for a named patient, or an authorised prescriber (the practitioner exemption).&nbsp;<\/span><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span style=\"font-weight: 400\">Key Takeaways<\/span><\/h2>\n\n\n\n<p><span style=\"font-weight: 400\">Therapeutic products can present serious risks of harm, especially if manufactured, advertised or used inappropriately or in ways that do not comply with applicable regulation. If you need advice about distributing or advertising your therapeutic products in New Zealand, contact <a href=\"https:\/\/legalvision.co.nz\/regulatory-lawyers-lp\">LegalVision\u2019s commercial health lawyers<\/a> on 0800 005 570 or fill out the form on this page.<\/span><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">FAQs<\/h2>\n\n\n\n<div class=\"schema-faq wp-block-yoast-faq-block\"><div class=\"schema-faq-section\" id=\"faq-question-1606880228344\"><strong class=\"schema-faq-question\"><span>What regulation is there over New Zealand <\/span><strong><strong><strong><strong><strong><strong><strong><strong><strong><strong><strong><strong><strong><strong><strong>therapeutic products?<\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong> <p class=\"schema-faq-answer\">In New Zealand, there are certain requirements for approval, classification, manufacture, sale, distribution, advertising, prescribing and dispensing of therapeutic products.<\/p> <\/div> <div class=\"schema-faq-section\" id=\"faq-question-1606880258379\"><strong class=\"schema-faq-question\"><strong><strong><strong><strong><strong><strong><strong><strong><strong><strong><strong><strong><strong><strong><strong><strong><strong><strong>What is a therapeutic product?<\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong> <p class=\"schema-faq-answer\">A therapeutic product includes medicines, medical devices and other related products.<\/p> <\/div> <div class=\"schema-faq-section\" id=\"faq-question-1606880271477\"><strong class=\"schema-faq-question\"><strong><strong><strong><strong><strong><strong><strong><strong><strong><strong><strong><strong><strong><strong><strong><strong>What is a medical device?<\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong> <p class=\"schema-faq-answer\">A medical device is any device, instrument, apparatus or appliance that is intended to be used primarily on human beings for a therapeutic purpose<\/p> <\/div> <\/div>\n\n\n\n\n<div class=\"not-prose m-feedback-prompt\">\n    <!-- Thumbs up\/down bar -->\n    <div class=\"m-feedback-prompt__main\">\n        <div class=\"m-feedback-prompt__title\">Was this article helpful?<\/div>\n        <div>\n            <!--span class=\"m-feedback-prompt__button--text\">Thanks!<\/span-->\n            <button type=\"button\" class=\"m-feedback-prompt__button m-feedback-prompt__button--yes\"\n                    data-analytics-link=\"feedback-prompt:yes\" aria-label=\"Agree\">\n                <i class=\"fa-regular fa-thumbs-up fa-3x\"><\/i>\n            <\/button>\n            <button 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value=\"https:\/\/legalvision.co.nz\/regulatory-and-compliance\/therapeutic-product\/\" type=\"hidden\" name=\"currenturl\"\n                   id=\"currenturl\">\n            <input value=\"Therapeutic Product Regulation in New Zealand\" type=\"hidden\" name=\"currenttitle\"\n                   id=\"currenttitle\">\n            <label>\n                <!-- display on thumbs-up -->\n                <span class=\"m-feedback-prompt__feedback m-feedback-prompt__feedback--yes\">\n                    Can you tell us <span class=\"font-semibold\">why<\/span> you found it helpful?\n                <\/span>\n\n                <!-- display on thumbs-down -->\n                <span class=\"m-feedback-prompt__feedback m-feedback-prompt__feedback--no text-lg\">\n                    How can we better improve this article?\n                <\/span>\n                <textarea name=\"feedbackmessage\" id=\"feedbackmessage\" required><\/textarea>\n            <\/label>\n\n            <div class=\"m-feedback-prompt__form--error\" id=\"form-submit-error\"><\/div>\n            <button id=\"submit-contact-form-button\" type=\"submit\" name=\"commit\" class=\"m-feedback-prompt__form--submit\"\n                    data-analytics-link=\"feedback-prompt:submit\">\n                Submit            <\/button>\n        <\/form>\n    <\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>There are a number of regulatory requirements for importing, distributing or otherwise supplying therapeutic products in New Zealand. If you are thinking about importing or supplying a therapeutic product in New Zealand, make sure that: your product is compliant with New Zealand laws; and you are aware of your legal requirements as the product sponsor.&nbsp;<a href=\"https:\/\/legalvision.co.nz\/regulatory-and-compliance\/therapeutic-product\/\">Continue reading <span class=\"sr-only\">&#8220;Therapeutic Product Regulation in New Zealand&#8221;<\/span><\/a><\/p>\n","protected":false},"author":13195,"featured_media":132,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","editor_notices":[],"footnotes":""},"categories":[8],"tags":[24,25,54,319,320,321],"class_list":["post-1872","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulatory-and-compliance","tag-startup","tag-small-business","tag-medium-business","tag-therapeutic-product","tag-medicine","tag-related-products"],"acf":[],"yoast_head":"<!-- This site is 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